CA2325337C - Use of live yeast cell derivative to treat bed sore pressure ulcers - Google Patents
Use of live yeast cell derivative to treat bed sore pressure ulcers Download PDFInfo
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Abstract
A stable composition is provided to treat and/or prevent pressure ulcer (bed sores) and related skin disorders, such as by topically applying to the skin the treatment composition containing an effective amount of a compound including live yeast cell derivative (LYCD), in a pharmaceutically acceptable anhydrous vehicle such as petrolatum as an occlusion in combination with a solvent, such as shark liver oil. The present invention includes use of a particular over the counter (OTC) skin protectant ointment containing biologically active live yeast cell derivative (LYCD) which is shown to be effective in the treatment of pressure ulcers in clinical trials. It has been found to minimize the risk of infection, patient discomfort and recovery times, as well as to provide a moist environment to facilitate healing, and for skin protection.
Description
USE OF LIVE YEAST CELL DERIVATIVE TO TREAT BED SORE PRESSURE
ULCERS
FIELD OF THE INVENTION
The present invention relates to topical treatments for pressure ulcers also known commonly as bed sores, which most commonly occur in non-ambulatory, bed ridden medical patients, or in patients with limited mobility.
BACKGROUND OF THE INVENTION
Pressure ulcers, commonly known as bedsores, are a vascular problem caused by a patient's constant weight bearing at a site due to inactivity. The mechanism is understood to be related to decreased blood flow through capillaries at the site; this results in deficient oxygenation of cells in the local area, which causes morbidity.
Pressure ulcers are wounds that occur as a result of prolonged pressure due to body weight against a surface such as a bed or wheel chair. Pressure ulcers, occur where a bony protuberance concentrates a person's weight against the skin and its underlying support. This causes vascular constriction which limits nutrient and oxygen blood flow in the area of the wound, so that the wound forms and worsens.
The incidence of pressure ulcers is high especially among certain risk groups including elderly patients admitted to hospitals for femoral fracture (66% incidence), critical care patients (33% incidence), and residents of skilled care facilities and nursing homes (up to 23%
incidence). A study of acute care facilities reported an incidence of 9.2% while one study of quadriplegic patients revealed a prevalence of 60%.
Several adjunctive therapies have been used in attempts to enhance pressure ulcer healing. Among these has been the application of a variety of topical agents. These have, included the topical use of zinc oxide (such as "DesitinTM"
OTC ointment). Vitamin A and vitamin D treatments such as "A&D" OTC ointments, a product known as"GranulexT"'", and petrolatum and lanolin in an emulsion are also prior art topical treatments. These have not proven effective in promoting healing of pressure ulcers.
The prior art also includes reference to the use of live yeast cell derivative (LYCD) to treat burn victims. A
study by Kaplan, "Acceleration of Wound Healing By A Live Yeast Cell Derivative", Arch Surg Vol. 119, Sept. 1984 pp.
1005-1008 showed that a concentration of 2,000 units/g of LYCD in an ointment base was effective in accelerating burn wound healing.
However, it must be noted that burn damage is qualitatively different from that of pressure ulcers. Cells are damaged by burns through de-naturing of the cell's protein. In contrast, pressure ulcers are caused by a local vascular deficiency.
In fact, the United States Dept. of Health and Human Services stated in " Treatment of Pressure Ulcers" Clinical Practice Guideline, Number 15, HHS, AH CPR Publication No.
95-0652, Dated December, 1994, at page 56 that yeast extracts, such as live yeast cell derivative (LYCD), are not recommended for treatment of pressure ulcers because of limited efficacy. Therefore, the use of live yeast cell derivative (LYCD) has not been previously proved to be effective in treatment of pressure ulcers.
U.S. Patent No.5,714,169 of Levin describes treating wounds, including pressure ulcers with topically applied medicinal composition in combination with a live yeast cell derivative (LYCD). However there is no proof that the live yeast cell derivative (LYCD) is anything but incidental, since medicinal recombinant growth factors are known as wound healing agents.
Moreover, US Patent No. 6,143,321 of Needham describes liposomes as medicinal formulations designed to promote the effectiveness of poorly water soluble components. In a liposome, an outer lipid layer, such as a phospholipid, surrounds and entraps a water soluble component therein.
Furthermore, US patent no. 5,776,441 of Scancarella, assigned to Avon Products, Inc., describes a lip balm composition of live yeast cell derivative LYCD in petrolatum. However, Scancarella '441 describes and gives examples of liquid or powdered live yeast cell derivative (LYCD), neither of which are liposome encapsulated.
US patent no. 5,874,479 of Martin, assigned to Warner Lambert, describes a wound composition that mentions treating decubitus ulcers among many types of wounds.
However, the studies it conducted were treatment of incision wounds on mice, not treatment of humans with pressure ulcers. In Table A of Martin '479, there is a comparison of four formulations, namely, 1) PREPARATION H , 2) petrolatum with LYCD, shark oil, and a mixture of pyruvate, vitamin E
and chicken fat, 3) petrolatum with LYCD and shark oil and 4) petrolatum only.
However, Martin '479 does not describe a method of treating pressure ulcers with a composition comprising petrolatum with liposome encapsulated live yeast cell derivative (LYCD )and shark liver oil.
Other wound healing treatment regimens are disclosed in W. Goodson et al. "Augentation of Some Aspects of Wound Healing By a 'Skin Respiratory Factor "', J Surg Res 1976 81:125-129, J. Niinikoski "The Effect of Blood and Oxygen Supply of the Biochemistry of Repair" (TK Hunt ed.) Wound Healing and Wound Infection: Theory and Surgical Practice, 1980 Appleton-Century-Crofts, NY, and Treatment of Pressure Ulcers. Clinical Practice Guideline No. 15, US Dept. of Health and Human Services, AHCPR Pub. No. 95-0652, Maibacvh, HF, Rovee DT: Epidermal Wound Healinq; Mosby, St. Louis, MO, 1972, Brody, HJ:
Chemical Peeling; Mosby, St. Louis, MO 1992:27-31; and Ghadially, et al., "Effects of Petrolatum on Stratum Corneum Structure and Function,". J.
AM.ACAD.DERM. 192:26;387-96 (VA Hospital Study NIH Grant).
Also known are Pulgiese, PT,et.al., "Some Biological Actions of Alkylglycerols from Shark Liver Oil," J. Ahern Complement Medicine. '98 4 (1):87-89, Loftssson, T., Petersen DS, " Unsaturated Glycerol Monoethers as Novel Skin Protection Enhancers," Dept. of Pharmacy, Univ. of Iceland, Reykjavik Pharmzie ' 97 Jun:52(6);463-5.
Live yeast cell derivative (LYCD) has been used to aid in healing and to reduce patient recovery time and discomfort after facial peeling, which is the controlled wounding of skin. It is believed that the live yeast cell derivative (LYCD) re-generates facial peeled skin with greater collagen levels and improved cosmetic appearance. Such skin facial wounds which have been effectively treated with live yeast cell derivative (LYCD) include those caused by dermabrasion, chemical burns from application of trichloroacetic acid, of thermal burns from a laser. The live yeast cell derivative (LYCD) supports natural homeostatic regulators found in skin cells and contains tissue respiratory factor (TRF) that increases cellular respiration. See footnotes 3,4,5.
However it is not known to provide a topical composition for treatment of pressure ulcers (bed sores) with biologically active yeast extract, including live yeast cell derivative (LYCD).
EMBODIMENTS OF THE INVENTION
It is therefore a feature of one embodiment of the present invention to promote prevention and treatment of pressure ulcers.
It is also a feature of another embodiment of the present invention to promote vascularization of capillary blood vessels to counteract the development of pressure ulcers.
It is yet a feature of another embodiment of the present invention to provide a skin protectant ointment containing live yeast cell derivative (LYCD) useful in the treatment of pressure ulcers.
It is a further feature of another embodiment of the present invention to make the previously ineffective use of live yeast cell derivative (LYCD) effective 5 in treating pressure ulcers.
It is also a feature of another embodiment of the present invention to minimize the risk of infection, patient discomfort and recovery times when treating pressure ulcers.
It is also a feature of another embodiment of the present invention to provide treatment modalities for all of the various stages of pressure ulcers.
It is also a feature of one embodiment of the present invention to promote collagen synthesis in fibroblasts by increasing oxygen, thereby, promoting cellular respiration, for the healing of pressure ulcers.
It is also a feature of one embodiment of the present invention to promote acceleration of re-epithelialization, angiogenesis, and pain reduction in patients with pressure ulcers.
SUMMARY OF THE INVENTION
The present invention relates to a topical composition for treating pressure ulcer bed sores and related skin disorders including alleviating bed sores of various degrees, said topical composition comprising a compound including liposome encapsulated live yeast cell derivative (LYCD), said composition being provided in a substantially anydrous pharmaceutically acceptable base.
In a preferred embodiment of the invention, the live yeast cell derivative (LYCD) is provided in an amount of about 200 to about 600 biologically active units per 100 grams of the composition, and the composition further comprises a skin enhancing penetration solvent.
In a more preferred embodiment, the composition comprises the following components, listed by percentage of the total composition.
Ingredient Ran4e (%w/w) Petrolatum 10 - 99.5%
Live Yeast Cell Derivative (LYCD) at least 200 biologically active units per 100 grams of the composition In yet another preferred embodiment, the composition comprises the following components, listed by percentage of the total composition:
In req dient Ranae (%w/w) Petrolatum 87.5%
Live Yeast Cell Derivative (LYCD) at least 600 biologically active units per 100 grams of the composition The present invention relates, in another embodiment to a method for treating patients prone to bed sore problems and related skin disorders, including alleviating bed sores of various degrees.
The above compositions and methods of the present invention includes the use of a skin protectant topically applied ointment containing an effective amount of live yeast cell derivative (LYCD), preferably as a lipsome encapsulated composition. The ointment of the present invention is effective by virtue of its skin penetration abilities in the treatment of bed sore pressure ulcers, as shown in clinical trials of the use of the subject matter of the present invention.
This topically applied ointment is used by dermatologists, plastic surgeons and cosmetic surgeons as an adjunct therapy to protect the wound and to promote healing. In its original use, it has been found to minimize the risk of infection, patient discomfort and recovery times. Clinical trials have shown similar results in the treatment of pressure ulcers (bed sores), especially in non-ambulatory patients.
An ointment of the present invention was shown in the clinical trials to be therapeutically effective in the prevention and treatment of inflammation in Stage I and Stage II pressure ulcers. In one clinical trial, an ointment of the present invention either resolved pressure ulcers by returning affected skin to pre-wound status, prevented further development, or markedly improved the pressure ulcer wounds treated during a five week clinical study.
Unlike the previous ineffective attempts to use live yeast cell derivative (LYCD) to treat pressure ulcers, the formulation of the present invention is effective because it enhances deep dermal penetration of the live yeast cell derivative (LYCD) to the capillaries and wounded tissues.
The deep dermal penetration occurs for three reasons.
First, the live yeast cell derivative (LYCD) is preferably incorporated as a liposome encapsulated composition, which enhances deep skin penetration. Second, a pharmacological solvent, such as shark liver oil, with its component mono-ethers, enhances skin penetration. Third, the preferably anhydrous base for the liquid live yeast cell derivative component formed with an occlusive agent, such as petrolatum provides an occlusion that keeps air out and opens skin pores up, causing sweating and resultant absorption of the live yeast cell derivative (LYCD) deep within the dermis.
ULCERS
FIELD OF THE INVENTION
The present invention relates to topical treatments for pressure ulcers also known commonly as bed sores, which most commonly occur in non-ambulatory, bed ridden medical patients, or in patients with limited mobility.
BACKGROUND OF THE INVENTION
Pressure ulcers, commonly known as bedsores, are a vascular problem caused by a patient's constant weight bearing at a site due to inactivity. The mechanism is understood to be related to decreased blood flow through capillaries at the site; this results in deficient oxygenation of cells in the local area, which causes morbidity.
Pressure ulcers are wounds that occur as a result of prolonged pressure due to body weight against a surface such as a bed or wheel chair. Pressure ulcers, occur where a bony protuberance concentrates a person's weight against the skin and its underlying support. This causes vascular constriction which limits nutrient and oxygen blood flow in the area of the wound, so that the wound forms and worsens.
The incidence of pressure ulcers is high especially among certain risk groups including elderly patients admitted to hospitals for femoral fracture (66% incidence), critical care patients (33% incidence), and residents of skilled care facilities and nursing homes (up to 23%
incidence). A study of acute care facilities reported an incidence of 9.2% while one study of quadriplegic patients revealed a prevalence of 60%.
Several adjunctive therapies have been used in attempts to enhance pressure ulcer healing. Among these has been the application of a variety of topical agents. These have, included the topical use of zinc oxide (such as "DesitinTM"
OTC ointment). Vitamin A and vitamin D treatments such as "A&D" OTC ointments, a product known as"GranulexT"'", and petrolatum and lanolin in an emulsion are also prior art topical treatments. These have not proven effective in promoting healing of pressure ulcers.
The prior art also includes reference to the use of live yeast cell derivative (LYCD) to treat burn victims. A
study by Kaplan, "Acceleration of Wound Healing By A Live Yeast Cell Derivative", Arch Surg Vol. 119, Sept. 1984 pp.
1005-1008 showed that a concentration of 2,000 units/g of LYCD in an ointment base was effective in accelerating burn wound healing.
However, it must be noted that burn damage is qualitatively different from that of pressure ulcers. Cells are damaged by burns through de-naturing of the cell's protein. In contrast, pressure ulcers are caused by a local vascular deficiency.
In fact, the United States Dept. of Health and Human Services stated in " Treatment of Pressure Ulcers" Clinical Practice Guideline, Number 15, HHS, AH CPR Publication No.
95-0652, Dated December, 1994, at page 56 that yeast extracts, such as live yeast cell derivative (LYCD), are not recommended for treatment of pressure ulcers because of limited efficacy. Therefore, the use of live yeast cell derivative (LYCD) has not been previously proved to be effective in treatment of pressure ulcers.
U.S. Patent No.5,714,169 of Levin describes treating wounds, including pressure ulcers with topically applied medicinal composition in combination with a live yeast cell derivative (LYCD). However there is no proof that the live yeast cell derivative (LYCD) is anything but incidental, since medicinal recombinant growth factors are known as wound healing agents.
Moreover, US Patent No. 6,143,321 of Needham describes liposomes as medicinal formulations designed to promote the effectiveness of poorly water soluble components. In a liposome, an outer lipid layer, such as a phospholipid, surrounds and entraps a water soluble component therein.
Furthermore, US patent no. 5,776,441 of Scancarella, assigned to Avon Products, Inc., describes a lip balm composition of live yeast cell derivative LYCD in petrolatum. However, Scancarella '441 describes and gives examples of liquid or powdered live yeast cell derivative (LYCD), neither of which are liposome encapsulated.
US patent no. 5,874,479 of Martin, assigned to Warner Lambert, describes a wound composition that mentions treating decubitus ulcers among many types of wounds.
However, the studies it conducted were treatment of incision wounds on mice, not treatment of humans with pressure ulcers. In Table A of Martin '479, there is a comparison of four formulations, namely, 1) PREPARATION H , 2) petrolatum with LYCD, shark oil, and a mixture of pyruvate, vitamin E
and chicken fat, 3) petrolatum with LYCD and shark oil and 4) petrolatum only.
However, Martin '479 does not describe a method of treating pressure ulcers with a composition comprising petrolatum with liposome encapsulated live yeast cell derivative (LYCD )and shark liver oil.
Other wound healing treatment regimens are disclosed in W. Goodson et al. "Augentation of Some Aspects of Wound Healing By a 'Skin Respiratory Factor "', J Surg Res 1976 81:125-129, J. Niinikoski "The Effect of Blood and Oxygen Supply of the Biochemistry of Repair" (TK Hunt ed.) Wound Healing and Wound Infection: Theory and Surgical Practice, 1980 Appleton-Century-Crofts, NY, and Treatment of Pressure Ulcers. Clinical Practice Guideline No. 15, US Dept. of Health and Human Services, AHCPR Pub. No. 95-0652, Maibacvh, HF, Rovee DT: Epidermal Wound Healinq; Mosby, St. Louis, MO, 1972, Brody, HJ:
Chemical Peeling; Mosby, St. Louis, MO 1992:27-31; and Ghadially, et al., "Effects of Petrolatum on Stratum Corneum Structure and Function,". J.
AM.ACAD.DERM. 192:26;387-96 (VA Hospital Study NIH Grant).
Also known are Pulgiese, PT,et.al., "Some Biological Actions of Alkylglycerols from Shark Liver Oil," J. Ahern Complement Medicine. '98 4 (1):87-89, Loftssson, T., Petersen DS, " Unsaturated Glycerol Monoethers as Novel Skin Protection Enhancers," Dept. of Pharmacy, Univ. of Iceland, Reykjavik Pharmzie ' 97 Jun:52(6);463-5.
Live yeast cell derivative (LYCD) has been used to aid in healing and to reduce patient recovery time and discomfort after facial peeling, which is the controlled wounding of skin. It is believed that the live yeast cell derivative (LYCD) re-generates facial peeled skin with greater collagen levels and improved cosmetic appearance. Such skin facial wounds which have been effectively treated with live yeast cell derivative (LYCD) include those caused by dermabrasion, chemical burns from application of trichloroacetic acid, of thermal burns from a laser. The live yeast cell derivative (LYCD) supports natural homeostatic regulators found in skin cells and contains tissue respiratory factor (TRF) that increases cellular respiration. See footnotes 3,4,5.
However it is not known to provide a topical composition for treatment of pressure ulcers (bed sores) with biologically active yeast extract, including live yeast cell derivative (LYCD).
EMBODIMENTS OF THE INVENTION
It is therefore a feature of one embodiment of the present invention to promote prevention and treatment of pressure ulcers.
It is also a feature of another embodiment of the present invention to promote vascularization of capillary blood vessels to counteract the development of pressure ulcers.
It is yet a feature of another embodiment of the present invention to provide a skin protectant ointment containing live yeast cell derivative (LYCD) useful in the treatment of pressure ulcers.
It is a further feature of another embodiment of the present invention to make the previously ineffective use of live yeast cell derivative (LYCD) effective 5 in treating pressure ulcers.
It is also a feature of another embodiment of the present invention to minimize the risk of infection, patient discomfort and recovery times when treating pressure ulcers.
It is also a feature of another embodiment of the present invention to provide treatment modalities for all of the various stages of pressure ulcers.
It is also a feature of one embodiment of the present invention to promote collagen synthesis in fibroblasts by increasing oxygen, thereby, promoting cellular respiration, for the healing of pressure ulcers.
It is also a feature of one embodiment of the present invention to promote acceleration of re-epithelialization, angiogenesis, and pain reduction in patients with pressure ulcers.
SUMMARY OF THE INVENTION
The present invention relates to a topical composition for treating pressure ulcer bed sores and related skin disorders including alleviating bed sores of various degrees, said topical composition comprising a compound including liposome encapsulated live yeast cell derivative (LYCD), said composition being provided in a substantially anydrous pharmaceutically acceptable base.
In a preferred embodiment of the invention, the live yeast cell derivative (LYCD) is provided in an amount of about 200 to about 600 biologically active units per 100 grams of the composition, and the composition further comprises a skin enhancing penetration solvent.
In a more preferred embodiment, the composition comprises the following components, listed by percentage of the total composition.
Ingredient Ran4e (%w/w) Petrolatum 10 - 99.5%
Live Yeast Cell Derivative (LYCD) at least 200 biologically active units per 100 grams of the composition In yet another preferred embodiment, the composition comprises the following components, listed by percentage of the total composition:
In req dient Ranae (%w/w) Petrolatum 87.5%
Live Yeast Cell Derivative (LYCD) at least 600 biologically active units per 100 grams of the composition The present invention relates, in another embodiment to a method for treating patients prone to bed sore problems and related skin disorders, including alleviating bed sores of various degrees.
The above compositions and methods of the present invention includes the use of a skin protectant topically applied ointment containing an effective amount of live yeast cell derivative (LYCD), preferably as a lipsome encapsulated composition. The ointment of the present invention is effective by virtue of its skin penetration abilities in the treatment of bed sore pressure ulcers, as shown in clinical trials of the use of the subject matter of the present invention.
This topically applied ointment is used by dermatologists, plastic surgeons and cosmetic surgeons as an adjunct therapy to protect the wound and to promote healing. In its original use, it has been found to minimize the risk of infection, patient discomfort and recovery times. Clinical trials have shown similar results in the treatment of pressure ulcers (bed sores), especially in non-ambulatory patients.
An ointment of the present invention was shown in the clinical trials to be therapeutically effective in the prevention and treatment of inflammation in Stage I and Stage II pressure ulcers. In one clinical trial, an ointment of the present invention either resolved pressure ulcers by returning affected skin to pre-wound status, prevented further development, or markedly improved the pressure ulcer wounds treated during a five week clinical study.
Unlike the previous ineffective attempts to use live yeast cell derivative (LYCD) to treat pressure ulcers, the formulation of the present invention is effective because it enhances deep dermal penetration of the live yeast cell derivative (LYCD) to the capillaries and wounded tissues.
The deep dermal penetration occurs for three reasons.
First, the live yeast cell derivative (LYCD) is preferably incorporated as a liposome encapsulated composition, which enhances deep skin penetration. Second, a pharmacological solvent, such as shark liver oil, with its component mono-ethers, enhances skin penetration. Third, the preferably anhydrous base for the liquid live yeast cell derivative component formed with an occlusive agent, such as petrolatum provides an occlusion that keeps air out and opens skin pores up, causing sweating and resultant absorption of the live yeast cell derivative (LYCD) deep within the dermis.
It is further noted that in an alternate embodiment the liposome encapsulated live yeast cell derivative may be provided in a petrolatum base, without the shark liver oil as a penetrating enhancing solvent, since petrolatum is also a skin penetration enhancer by itself, as well as an occlusive agent.
Moreover, in an alternate embodiment, the liposome encapsulated live yeast cell derivative may be provided in a petrolatum base, but with one or more other penetrating enhancing solvents, such as oleic acid, trihydroxy compounds, ethoxydiglycol, propylene gylcol, polyethylene glycol, terpenes, trichloroethanol, urea, butylene glycol, alcohols, dimethyl formamide, dimethyl sulfoxide (DMSO), 1 dodecylazacycloheptan-2-one, methyidecyl sulfoxide (DMS) and N-methyl pyrrolidone.
Therefore, the required components of the formulation of the present invention include preferably petrolatum, as a vehicle for the LYCD treatment composition to enhance occlusion, shark liver oil to enhance penetration and liposome encapsulation of the live yeast cell derivative (LYCD), which is provided in biologically active units of yeast.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the present invention, a method is provided for the treatment of pressure ulcers, also known as bedsores, as well as excoriation and treatment of the peri-wound area. The method includes the topical application of an ointment of the present invention containing an effective amount of biologically active live yeast cell derivative (LYCD) encapsulated liposome as an adjunctive therapy as appropriate to the particular treatment modalities of the various stages of pressure ulcers (stage I through IV) as defined by the National Pressure Ulcer Advisory Panel Consensus Development Conference (NPUAP, 1989).
Moreover, in an alternate embodiment, the liposome encapsulated live yeast cell derivative may be provided in a petrolatum base, but with one or more other penetrating enhancing solvents, such as oleic acid, trihydroxy compounds, ethoxydiglycol, propylene gylcol, polyethylene glycol, terpenes, trichloroethanol, urea, butylene glycol, alcohols, dimethyl formamide, dimethyl sulfoxide (DMSO), 1 dodecylazacycloheptan-2-one, methyidecyl sulfoxide (DMS) and N-methyl pyrrolidone.
Therefore, the required components of the formulation of the present invention include preferably petrolatum, as a vehicle for the LYCD treatment composition to enhance occlusion, shark liver oil to enhance penetration and liposome encapsulation of the live yeast cell derivative (LYCD), which is provided in biologically active units of yeast.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the present invention, a method is provided for the treatment of pressure ulcers, also known as bedsores, as well as excoriation and treatment of the peri-wound area. The method includes the topical application of an ointment of the present invention containing an effective amount of biologically active live yeast cell derivative (LYCD) encapsulated liposome as an adjunctive therapy as appropriate to the particular treatment modalities of the various stages of pressure ulcers (stage I through IV) as defined by the National Pressure Ulcer Advisory Panel Consensus Development Conference (NPUAP, 1989).
In accordance with the present invention the method for treating and curing pressure ulcers includes wound cleaning at least once a day and preferably as often as required during a day, by topical application of an ointment containing an effective amount of biologically active live yeast cell derivative,(LYCD), preferably an ointment prepared with a petrolatum base or similar water resistant carrier material for the live yeast cell derivative (LYCD), which is preferably a liposome encapsulated LYCD compo.sition and a pharmaceutically acceptable carrier, the applications of ointment to completely cover the pressure ulcer and surrounding area of skin, and then preferably applying a clean dry dressing. In accordance with the invention the treatment method is continued for at least about two weeks or longer, if required.
The biologically active live yeast cell derivative (LYCD) used in the present invention is quantified as a quantity of biologically active units, of an amount of about 200 more biologically active units per applied dose, such as for example, 600 biologically active units, or more.
Biologically active live yeast cell derivative (LYCD) typically is measured as a Warburg assay at not less than 8 biologically active units per milligram of yeast extract. To obtain 600 biologically active units, it is provided from raw yeast extract in an amount of about 600 biologically active units per 100 grams of finished product.
The biologically active live yeast cell derivative (LYCD) is commercially available as an extract of varying amounts of active live yeast cell derivative in numerous forms, including as a liquid, a powder, a concentrate, a gel, a paste or as a liposome encapsulated LYCD.
Although all of these forms are efficacious, the preferable form is an extract encapsulated within a liposome.
The carriers for the liquid or concentrates include water, alcohols, glycols, and preserved serums. The powders have extenders such as, but not limited to, dextrose or starches. The liposomes can be of any suitable form, such as for example, with phospolipids.
Among commercially available yeast extract is product no. 8013-01-2 of Red Star Yeast and Products of Milwaukee, Wisconsin, which yeast extract is a spray dried yeast extract fraction.
According to the National Formulary of the United States Pharmacopeia(1998), yeast extract is a peptone-like derivative of yeast cells (Saccharomyces) which is water-soluble.
In a preferred embodiment, the over the-counter (OTC) skin protectant ointment of the present invention is predominately petrolatum U.S.P. as a base carrier for live yeast cell derivative (LYCD) with a pharmaceutically acceptable delivery topical vehicle, which may also contain the following optional ingredients: yucca extract, ceramides, shark liver oil, Vitamin E (tocopherol), benzyl alcohol, and green tea extract.
Each of these components has been shown in the medical literature to have effects that promote healing by a variety of mechanisms.
The yeast extract, which is the source of the live cell derivative (LYCD),of various biological activity, has been reported to promote collagen synthesis in fibroblasts by increasing oxygen, which may be important for promoting cellular respiration and for the healing of pressure ulcers.
See footnotes 3,4,5. Other related effects of live yeast cell derivative (LYCD) include the acceleration of re-epithelialization, angiogenesis, and pain reduction.
Other ingredients that may be included in the topical ointment of the invention include yeast extract having a high vitamin B content and which is characterized by a liposomal delivery system. Further ingredients include yucca extract, containing complex polysaccharides, which increases moisturization, which may be important in the treatment of pressure ulcers, as well as promoting a soothing ingredient much like aloe vera; ceramides, which normalize barrier function by regulating fluid levels; and to enhance moisturization, wherein they are the mortars in the brick and mortar model of the stratum corneum; a skin penetration enhancing solvent such as shark liver oil, containing unsaturated glycerol monoethers, 6, and Vitamin E, which is a well-known antioxidant, which moderates the inflammation reaction resulting in accelerated wound recovery 7, 8.
Furthermore, benzyl alcohol is often used as an anti-microbial in ingestables and injectables 10, 11. It has topical anesthetic properties. It is also very mild, as illustrated by its use in intravaginal preparations. Green tea extract is also used. It is a known antioxidant and also a source of catechins and polyphenols. It is also a free radical scavenger and a source of tannin.
To increase shelf life, mineral oil and lanolin alcohol, such as provided in the AMERCHOLTM L-101 product, stabilize the formulation.
Clinical studies, which have been conducted with statistically significant results, reveal that the method of the present invention including the application of the topical ointment of the present invention, is effective in treating and reducing the effects of pressure ulcers (bed sores) in non ambulatory nursing and adult home patients.
The resultant topical ointment is a comfortable delivery vehicle, which delivers an effective amount therein of yeast of extract, and related components to the skin in a manner which promotes penetration and vascularization of capillaries and treatment of pressure ulcers.
The following examples illustrate typical topically applied skin care products, which can be prepared using conventional procedures, from the following ingredients with ranges of acceptable percentages shown by weight, and typical preferred percentage by weight showns Preferably the carrier for the active live yeast cell derivative (LYCD) component is an anhydrous base, such as for example, petrolatum.
The live yeast cell derivative (LYCD) is quantified in the following Formulations 1 through 6 as biologically active units per 100 grams of finished product.
The formulations are illustrative only:
Formulation #1:
Ingredient Ranqe(%w/w) Preferred (%w/w) Petrolatum 10-99.5 50-99.5 Live Yeast Cell Derivative (LYCD) at least 200 about 600 Formulation # 2:
In the aforementioned clinical trials, substantial improvement occurred with the preferred embodiment of the following Formulation #2, which quantifies the live yeast cell derivative (LYCD) as biologically active units per loo grams of finished product. The reference to Amerchol L-101 refers to a commercial mixture of mineral oil and lanolin alcohol.
Ingredient(% w/w) Range ($wjw) Preferred Petrolatum 10-99 88.95 Amerchol L-101 0.1-30 7 Ceramides 0.0-5 0.1 Shark Liver Oil 0.1-25 0.25 Yucca Extract 0.0-50 1.0 Tocopherol (Vitamin E) 0.0-10 0.1 Benzyl Alcohol 0.0-5.0 1.0 Green Tea Extract 0.0-10 0.1 LYCD (Liposome encapsulated) at least 200 about 600 Other formulations with anhydrous carriers include:
Formulation 13:
Ingredient Range(%w,(w) Preferred (%wlw) Petrolatum 10-99.5 50-99.5 (preferred 50-99.5) Mineral Oil 0.0-99.5 7 Lanolin Alcohol 0.0-10 1 Yucca Glauca Extract 0.0-50 1 Shark Liver Oil 0.0-5. 0.25 Vitamin E 0.0-10.0 0.1 Benzyl Alcohol 0.0-5.0 1.0 Green Tea Extract 0.0-10.0 0.1 Ceramides 0.0-5.0 0.1 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of finished product.
Formulation 1 4:
Ingredient Range(%wfw) Preferred (%w/w) Petrolatum 10-90.0 50-99.5 Mineral Oil 0.0-70.0 10.0 Paraffin Wax 0.0-50.0 5.0 Lanolin Alcohol 0.0-20.0 1.0 Yucca Glauca Extract 0.0-70.0 2.0 Aloe Vera Gel 0.0-70.0 1.0 Shark Liver Oil 0.0-25.0 0.25 Green Tea Extract 0.0-70.0 0.25 Benzyl Alcohol 0.0-10.0 1.0 Vitamin E 0.0-25.0 0.1 Vitamin A 0.0-5.0 0.2 Vitamin D 0.0-1.0 0.2 Ceramides 0.0-5.0 0.25 Soybean Extract 0.0-25 0.25 Corn Oil 0.0-25 0.25 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of biologically active finished product.
In the above noted formulation, Vitamin D is provided at about 20,000 International units (IU) per gram. Vitamin A is provided at about 1,000,000 International units (IU) per gram. Vitamin E is provided at about 1.1 million International units (IU) per gram, as Tocopheryl Acetate.
Formulation 1 5:
Ingredient Ranqe(%wJwl Preferred (%wlw) Petrolatum 10-99.5 50-99.5 Mineral Oil 0.0 -5.0 6.5 Lanolin Alcohol 0.0-5.0 0.35 Yucca Glauca Extract 0.0-10.0 1.0 Shark Liver Oil 0.0-10.0 0.30 Green Tea Extract 0.0-25.0 0.1 Benzyl Alcohol 0.0-10.0 0.5 Vitamin E 0.0-10.0 0.1 Ceramides 0.0-5.0 0.1 Hydrogenated Vegetable Oil 0.0 -99.5 51.05 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of biologically active finished product.
In the above formulation, Vitamin E is provided at about 1.1 million International units (IU) per gram.
While the aforementioned formulations #1 through #5 are preferably in an anhydrous carrier, such as petrolatum, for example, it has also been found that a typical cream version of the topical applied ointment in an aqueous base can be effective in treating early Stage I pressure ulcers, before the pressure ulcers bed sores advance to Stage II pressure ulcers. The following formulation is in an aqueous cream base.
Formulation # 6:
Inctredient Preferred Rw/w) Water balance of composition Ca rbome rTM 0.3 Glycerin 2.0 Methylparaben 0.2 Yucca Extract 1.0 Triethanolamine 0.6 Shark Liver Oil 0.1 Green Tea Extract 0.01 Benzyl alcohol 1.0 Imidazolidinyl Urea 0.3 Vitamin E 0.1 Emulsifying Wax 6.0 PPG-2 Myristyl Ether Propionate 3.5 Ceramides 0.1 Squalane 3.0 White wax 1.0 Dimethicone 1.0 Propylparaben 0.1 Live Yeast Cell from about 200 biologically Derivative (LYCD) active units per 100 grams (liposome encapsulated) finished product The present invention therefore comprises a method for the prevention and/or treatment of pressure ulcers (bedsores) and related skin disorders with the compositions of the present invention.
The method comprises the steps of the topical application of suitable compositions containing live yeast cell derivative (LYCD), preferably liposome encapsulated in a suitable base, such as petrolatum which helps occlusion to increase penetration of the live yeast cell derivative (LYCD); which also helps penetration to the wound site in the dermis.
Penetration is also enhanced by the addition of a pharmacological skin penetration enhancing solvent, such as shark liver oil, with its component monoethers.
In general, the treatment composition suitable for use in accordance with the invention containing live yeast cell derivative (LYCD), may be applied in any dermatological acceptable vehicle such as a gel, lotion, cream, ointment or pad applied formulation, which may or may not be emulsified and may contain ingredients to improve, modify, or stabilize the formulation physically or cosmetically. Other suitable formulations will be apparent to those skilled in the art.
However, it has been found that water based cream formulations are primarily only effective in treating early Stage I pressure ulcers, so anhydrous bases, such as petrolatum, are preferred.
The treatment compositions of the invention improves the fluid and homeostatic regulation of the skin and tissues to which it is applied, preferably by frequent periodical application over an extended period of time without undue irritation to the skin or any other side effects.
Generally, the topical applications are applied periodically such as one or two times per day.
EXAMPLES
The preferred embodiment of Formulation no. 2 above noted was used in the following clinical studies, which disclose the efficacy thereof in treating pressure ulcers on human patients.
Example 1:
The use of petrolatum was compared to the ointment of the present invention in the Treatment of Pressure Ulcers, in a study by Kuflik, A., Stillo J., Sanders, D., Roland, P.T., Sweeney, O.T., and Lemke, P. dated November 19, 1999.
The Formulation No. 2 noted above was a new topically applied, non-prescription medication that was introduced for re-epithelization of ulcers and erosions of the skin. It was found that the formulation of the present invention combines the nurturing and barrier effect of petrolatum with several other wound healing ingredients.
The object of this study was to compare therapeutic effects of the formulation No. 2 noted above against petrolatum by itself as an active ingredient in treating pressure ulcers of shallow depth (Stage I & II). It is noted that petrolatum is the anhydrous base ointment component in the preferred embodiment of the formulation of the present invention.
A six-weeks randomized, double-blinded study was performed on twenty patients with Stage I or Stage II
ulcers. These patients received either Formulation Number 2 of the present invention in an Ointment or petrolatum, which served as a control.
The results showed complete resolution in a majority of pressure ulcers after a few weeks while only 1/3 of the pressure ulcers being treated with petrolatum resolved in the same period of time.
It was therefore concluded that preliminary results showed that the ointment of the present invention, as in Formulation No. 2, is a safe and effective treatment for Stage I & II pressure ulcers.
Previous treatments for pressure ulcers have included various topical medications, such as creams, ointments and hydrocolloid dressings; encouragement for movement; and cessation of all potentially confounding conditions that could perpetuate the ulcer. Topically applied medications include a variety of ingredients that fit into both prescription and non-prescription categories.
In this clinical study there was compared the therapeutic effectiveness of the ointment of the present invention, as a topically applied preparation with a novel combination of ingredients (see below), against its base component petrolatum in a scientifically controlled, randomized, double-blinded, control study.
The study consequently considered the ointment of the present invention as part of a regimen for treatment of other types of wounds such as Stage I & Stage II Pressure Ulcers.
The ingredients in the Formulation No. 2 ointment and their proposed pharmacological actions include: petrolatum, which helps control water loss from damaged skin by providing an occlusive protective layer while promoting normal skin barrier recovery (See footnote 9); liposome encapsulated live yeast cell derivative (LYCD) which promotes collagen synthesis through increased tissue oxygenation and cellular respiration,(see footnotes 3, 4, 5) shark liver oil which assists in skin penetration of other ingredients,(see footnote 6); catechins in green tea extract and vitamin E, which are free radical antioxidants and moderators of inflammation; benzyl alcohol, which has antimicrobial and local anesthetic properties(see footnotes 10, 11); ceramides, which are normal components of the stratum corneum, where they form a barrier to control moisture loss from the skin, and yucca extract which is used for its skin moisturizing properties.
Two separate study groups totaling twenty patients were conducted. Patients with Stage I or Stage II pressure ulcers were assigned twice daily (BID) treatment with formulation number 2 of the present invention, or with petrolatum by itself as an active ingredient. No other treatments were used.
The dispensing tubes containing formulation number 2 noted above, or petrolatum, were randomly numbered and their contents blinded from the patients, physicians and nursing staffs.
Patients with pressure ulcers having complex underlying etiologies such as venous stasis and severe diabetes were excluded from the study. Pressure ulcers were assessed for stage, size, erythema, and tenderness at the beginning and end of the study. Patients were monitored for any adverse effects, such as hypersensitivity, rash, or itching. Before and after photographs were taken of the pressure ulcers, the attending physicians were allowed to terminate patients from the study.
Nineteen patients having either Stage 1 or Stage II
Pressure Ulcers were entered into this study. Eighteen out of nineteen patients had one ulcer and one had two ulcers.
These nineteen patients were randomly placed in either the Group being treated with Formulation No. 2 of the present invention or the Petrolatum Group.
As noted in Table I here, ten patients totaling eleven ulcers were in the Group being treated with Formulation No.
2 of the present invention. Eight patients totaling nine ulcers finished the study. Two patients out of ten did not finish the study. One patient with a Stage I Ulcer was terminated because of medical conditions and the other with a Stage II Ulcer was discontinued because of non-improvement without deterioration. Nine of the remaining ulcers out of nine treated with the Formulation No. 2 of the present invention showed some level of improvement.
With respect to Stage I Pressure Ulcers: five of the nine pressure ulcers in this group were Stage I. Four out of five Stage I Ulcers were resolved by the end of the study. One out of five Stage I Ulcers was improved.
Four of the nine pressure ulcers were Stage II. One of the four Stage II Ulcers was resolved by the end of the study. Three of the four Stage II Ulcers were improved by the end of the study.
With respect to the Petrolatum Group, as in Table II
herein, nine patients totaling nine ulcers were in the Petrolatum Group. Two of the patients were terminated from the study because of worsening. Both had a Stage I Pressure Ulcer. Five of the remaining seven ulcers were Stage I.
Two of the remaining seven ulcers were Stage II.
Of the Stage I Pressure Ulcers: two out of five Stage I
Ulcers resolved by the end of the study. One out of five Stage I Ulcers showed no change. Two out of five Stage I
Ulcers worsened. concerning Stage II Pressure Ulcers: two out of two Stage II Pressure Ulcers worsened by the end of the study.
There were no complaints of itching, sensitivity or rash from either of the ointments.
Table I: Formulation No. 2 Ointment Patient Ulcer Stage Size (cm/diam) Erythema Tenderness Start 6 Weeks Start 6 Weeks Start 6 Weeks 1 One 1.5 Resolved Moderate Absent Non Applicable 2 One 1.0 Resolved Moderate Absent Non Applicable 3 One 0.7 Resolved Moderate Absent Non Applicable 4 One 2.0 0.3 Moderate Absent Non Applicable One 1.2 Terminated because of medical conditions 6 One 2.0 Resolved Moderate Absent Non Applicable 6 Two 1.1 0.7 Severe Mild Non Applicable 7 Two 3.0 1.0 Severe Mild Very 1V1ild 8 Two 4.0 1.5 Severe Mild Very Mild 9 Two 0.8 Resolved Moderate Absent Non Applicable Two 1.3 Discontinued because of non-improvement Table II: Petrolatum Control Group Patient Ulcer Stage Size (cm/diam) Erythema Tenderness Start 6 Weeks Start 6 Weeks Start 6 Weeks 1 One 1.2 Resolved Severe Moderate Mild 2 One 0.7 Resolved Moderate Absent N/A
3 One 0.7 0.7 Moderate Mild N/A
4 One 0.8 1.0 Mild Severe Not Tested One to Two 0.2 0.4 Mild Mild N/A
6 One 1.5 Terminated because of worsening 7 One 1.3 Terminated because of worsening 8 Two 0.4 1.0 Mild Moderate N/A
9 Two 4.0 6.0 Moderate Severe Very Mild 5 Conclusions:
The ointment of Formulation No. 2 of the present invention was found to be safe and effective in the treatment of pressure ulcers. It helped resolve the ulcers in a timely manner and did not have any side effects. It also was shown to be more effective than its base of petrolatum given the period of the study. This may be secondary to its additional wound healing components. The ointment of Formulation No. 2 was found therefore to also be useful in combination with other products for the treatment of pressure ulcers.
Footnote References:
(1) Chiarello, S. Skin Resurfacing: The Triple Technique, Cos. Derm. Oct. 1996:26-29.
.20 (2) Resnik, B., and Resnik, S. TCA Cream Skin Peel and Segmental Laser Resurfacing: Effective Combination Treatment of Rhytids and Solar Dyschromia. Cos.
Derm. 1999, 31-34 (3) Bentley JP, Hunt TK, Weiss JB, Taylor CM, Hanson, AN, Davies GH, Halliday BJ, Peptides from yeast cell derivative stimulate wound healing. Arch Surg. 1990 May; 125(5):641-64.
(4) Crowe MJ, McNeill RB, Schlemm DJ, Greenbaigh OH.
Topical application of yeast extract accelerates the wound healing of diabetic mice. J Burn Care Rehab.
1999 Mar-Apr; 2 (2):155-162 (5) Kaplan JZ. Acceleration of wound healing by live yeast cell derivative. Arch Surg. 19984;
119(9):1005-1008.
(6) Loftsson T, Peterson DS, Le Goffic F, Olafsson JH.
.15 Unsaturated glycerol monoethers as novel skin penetration enhancers. Pharmazie, 1997, June;
52(6):463-465 (7) Katiyar, S., Matsui, M., Ehmets, C., and Mulchter, H. Polyphenolic antioxidant (-)- epigallocatechin-3-gallate from green tea reduces UVB-induced inflammatory responses and infiltration of leukocytes in human skin. Photochem, Photobiol, Feb; 69(2):148-53.
(8) Fuchs, J., Huflejt, M., Rothfuss, L., Wilson, D., Carcamo, G., and Packer, L. Impairment of Enzymatic and Nonenzymatic Antioxidants in Skin by UVB
Irradiation, J. Invest. Dermatol. 93:769-773, 1989.
(9) Ghadially, R., Halkier-Scrensen, L., Elias, P., Effects of petrolatum on stratum corneum structure and function, J. Am. Acad. Dermatol 1992;26:387-96.
(10) Physicians Desk Reference. 1995;49 Edition: See:
Ativan Injection, p2644; Hexadrol Injection, p1751;
Vasotec Injection, p1648.
The biologically active live yeast cell derivative (LYCD) used in the present invention is quantified as a quantity of biologically active units, of an amount of about 200 more biologically active units per applied dose, such as for example, 600 biologically active units, or more.
Biologically active live yeast cell derivative (LYCD) typically is measured as a Warburg assay at not less than 8 biologically active units per milligram of yeast extract. To obtain 600 biologically active units, it is provided from raw yeast extract in an amount of about 600 biologically active units per 100 grams of finished product.
The biologically active live yeast cell derivative (LYCD) is commercially available as an extract of varying amounts of active live yeast cell derivative in numerous forms, including as a liquid, a powder, a concentrate, a gel, a paste or as a liposome encapsulated LYCD.
Although all of these forms are efficacious, the preferable form is an extract encapsulated within a liposome.
The carriers for the liquid or concentrates include water, alcohols, glycols, and preserved serums. The powders have extenders such as, but not limited to, dextrose or starches. The liposomes can be of any suitable form, such as for example, with phospolipids.
Among commercially available yeast extract is product no. 8013-01-2 of Red Star Yeast and Products of Milwaukee, Wisconsin, which yeast extract is a spray dried yeast extract fraction.
According to the National Formulary of the United States Pharmacopeia(1998), yeast extract is a peptone-like derivative of yeast cells (Saccharomyces) which is water-soluble.
In a preferred embodiment, the over the-counter (OTC) skin protectant ointment of the present invention is predominately petrolatum U.S.P. as a base carrier for live yeast cell derivative (LYCD) with a pharmaceutically acceptable delivery topical vehicle, which may also contain the following optional ingredients: yucca extract, ceramides, shark liver oil, Vitamin E (tocopherol), benzyl alcohol, and green tea extract.
Each of these components has been shown in the medical literature to have effects that promote healing by a variety of mechanisms.
The yeast extract, which is the source of the live cell derivative (LYCD),of various biological activity, has been reported to promote collagen synthesis in fibroblasts by increasing oxygen, which may be important for promoting cellular respiration and for the healing of pressure ulcers.
See footnotes 3,4,5. Other related effects of live yeast cell derivative (LYCD) include the acceleration of re-epithelialization, angiogenesis, and pain reduction.
Other ingredients that may be included in the topical ointment of the invention include yeast extract having a high vitamin B content and which is characterized by a liposomal delivery system. Further ingredients include yucca extract, containing complex polysaccharides, which increases moisturization, which may be important in the treatment of pressure ulcers, as well as promoting a soothing ingredient much like aloe vera; ceramides, which normalize barrier function by regulating fluid levels; and to enhance moisturization, wherein they are the mortars in the brick and mortar model of the stratum corneum; a skin penetration enhancing solvent such as shark liver oil, containing unsaturated glycerol monoethers, 6, and Vitamin E, which is a well-known antioxidant, which moderates the inflammation reaction resulting in accelerated wound recovery 7, 8.
Furthermore, benzyl alcohol is often used as an anti-microbial in ingestables and injectables 10, 11. It has topical anesthetic properties. It is also very mild, as illustrated by its use in intravaginal preparations. Green tea extract is also used. It is a known antioxidant and also a source of catechins and polyphenols. It is also a free radical scavenger and a source of tannin.
To increase shelf life, mineral oil and lanolin alcohol, such as provided in the AMERCHOLTM L-101 product, stabilize the formulation.
Clinical studies, which have been conducted with statistically significant results, reveal that the method of the present invention including the application of the topical ointment of the present invention, is effective in treating and reducing the effects of pressure ulcers (bed sores) in non ambulatory nursing and adult home patients.
The resultant topical ointment is a comfortable delivery vehicle, which delivers an effective amount therein of yeast of extract, and related components to the skin in a manner which promotes penetration and vascularization of capillaries and treatment of pressure ulcers.
The following examples illustrate typical topically applied skin care products, which can be prepared using conventional procedures, from the following ingredients with ranges of acceptable percentages shown by weight, and typical preferred percentage by weight showns Preferably the carrier for the active live yeast cell derivative (LYCD) component is an anhydrous base, such as for example, petrolatum.
The live yeast cell derivative (LYCD) is quantified in the following Formulations 1 through 6 as biologically active units per 100 grams of finished product.
The formulations are illustrative only:
Formulation #1:
Ingredient Ranqe(%w/w) Preferred (%w/w) Petrolatum 10-99.5 50-99.5 Live Yeast Cell Derivative (LYCD) at least 200 about 600 Formulation # 2:
In the aforementioned clinical trials, substantial improvement occurred with the preferred embodiment of the following Formulation #2, which quantifies the live yeast cell derivative (LYCD) as biologically active units per loo grams of finished product. The reference to Amerchol L-101 refers to a commercial mixture of mineral oil and lanolin alcohol.
Ingredient(% w/w) Range ($wjw) Preferred Petrolatum 10-99 88.95 Amerchol L-101 0.1-30 7 Ceramides 0.0-5 0.1 Shark Liver Oil 0.1-25 0.25 Yucca Extract 0.0-50 1.0 Tocopherol (Vitamin E) 0.0-10 0.1 Benzyl Alcohol 0.0-5.0 1.0 Green Tea Extract 0.0-10 0.1 LYCD (Liposome encapsulated) at least 200 about 600 Other formulations with anhydrous carriers include:
Formulation 13:
Ingredient Range(%w,(w) Preferred (%wlw) Petrolatum 10-99.5 50-99.5 (preferred 50-99.5) Mineral Oil 0.0-99.5 7 Lanolin Alcohol 0.0-10 1 Yucca Glauca Extract 0.0-50 1 Shark Liver Oil 0.0-5. 0.25 Vitamin E 0.0-10.0 0.1 Benzyl Alcohol 0.0-5.0 1.0 Green Tea Extract 0.0-10.0 0.1 Ceramides 0.0-5.0 0.1 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of finished product.
Formulation 1 4:
Ingredient Range(%wfw) Preferred (%w/w) Petrolatum 10-90.0 50-99.5 Mineral Oil 0.0-70.0 10.0 Paraffin Wax 0.0-50.0 5.0 Lanolin Alcohol 0.0-20.0 1.0 Yucca Glauca Extract 0.0-70.0 2.0 Aloe Vera Gel 0.0-70.0 1.0 Shark Liver Oil 0.0-25.0 0.25 Green Tea Extract 0.0-70.0 0.25 Benzyl Alcohol 0.0-10.0 1.0 Vitamin E 0.0-25.0 0.1 Vitamin A 0.0-5.0 0.2 Vitamin D 0.0-1.0 0.2 Ceramides 0.0-5.0 0.25 Soybean Extract 0.0-25 0.25 Corn Oil 0.0-25 0.25 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of biologically active finished product.
In the above noted formulation, Vitamin D is provided at about 20,000 International units (IU) per gram. Vitamin A is provided at about 1,000,000 International units (IU) per gram. Vitamin E is provided at about 1.1 million International units (IU) per gram, as Tocopheryl Acetate.
Formulation 1 5:
Ingredient Ranqe(%wJwl Preferred (%wlw) Petrolatum 10-99.5 50-99.5 Mineral Oil 0.0 -5.0 6.5 Lanolin Alcohol 0.0-5.0 0.35 Yucca Glauca Extract 0.0-10.0 1.0 Shark Liver Oil 0.0-10.0 0.30 Green Tea Extract 0.0-25.0 0.1 Benzyl Alcohol 0.0-10.0 0.5 Vitamin E 0.0-10.0 0.1 Ceramides 0.0-5.0 0.1 Hydrogenated Vegetable Oil 0.0 -99.5 51.05 Phospholipids 0.0-20.0 1.25 Live Yeast Cell Derivative (LYCD) at least 200 about 600 The LYCD is expressed as biologically active units per 100 grams of biologically active finished product.
In the above formulation, Vitamin E is provided at about 1.1 million International units (IU) per gram.
While the aforementioned formulations #1 through #5 are preferably in an anhydrous carrier, such as petrolatum, for example, it has also been found that a typical cream version of the topical applied ointment in an aqueous base can be effective in treating early Stage I pressure ulcers, before the pressure ulcers bed sores advance to Stage II pressure ulcers. The following formulation is in an aqueous cream base.
Formulation # 6:
Inctredient Preferred Rw/w) Water balance of composition Ca rbome rTM 0.3 Glycerin 2.0 Methylparaben 0.2 Yucca Extract 1.0 Triethanolamine 0.6 Shark Liver Oil 0.1 Green Tea Extract 0.01 Benzyl alcohol 1.0 Imidazolidinyl Urea 0.3 Vitamin E 0.1 Emulsifying Wax 6.0 PPG-2 Myristyl Ether Propionate 3.5 Ceramides 0.1 Squalane 3.0 White wax 1.0 Dimethicone 1.0 Propylparaben 0.1 Live Yeast Cell from about 200 biologically Derivative (LYCD) active units per 100 grams (liposome encapsulated) finished product The present invention therefore comprises a method for the prevention and/or treatment of pressure ulcers (bedsores) and related skin disorders with the compositions of the present invention.
The method comprises the steps of the topical application of suitable compositions containing live yeast cell derivative (LYCD), preferably liposome encapsulated in a suitable base, such as petrolatum which helps occlusion to increase penetration of the live yeast cell derivative (LYCD); which also helps penetration to the wound site in the dermis.
Penetration is also enhanced by the addition of a pharmacological skin penetration enhancing solvent, such as shark liver oil, with its component monoethers.
In general, the treatment composition suitable for use in accordance with the invention containing live yeast cell derivative (LYCD), may be applied in any dermatological acceptable vehicle such as a gel, lotion, cream, ointment or pad applied formulation, which may or may not be emulsified and may contain ingredients to improve, modify, or stabilize the formulation physically or cosmetically. Other suitable formulations will be apparent to those skilled in the art.
However, it has been found that water based cream formulations are primarily only effective in treating early Stage I pressure ulcers, so anhydrous bases, such as petrolatum, are preferred.
The treatment compositions of the invention improves the fluid and homeostatic regulation of the skin and tissues to which it is applied, preferably by frequent periodical application over an extended period of time without undue irritation to the skin or any other side effects.
Generally, the topical applications are applied periodically such as one or two times per day.
EXAMPLES
The preferred embodiment of Formulation no. 2 above noted was used in the following clinical studies, which disclose the efficacy thereof in treating pressure ulcers on human patients.
Example 1:
The use of petrolatum was compared to the ointment of the present invention in the Treatment of Pressure Ulcers, in a study by Kuflik, A., Stillo J., Sanders, D., Roland, P.T., Sweeney, O.T., and Lemke, P. dated November 19, 1999.
The Formulation No. 2 noted above was a new topically applied, non-prescription medication that was introduced for re-epithelization of ulcers and erosions of the skin. It was found that the formulation of the present invention combines the nurturing and barrier effect of petrolatum with several other wound healing ingredients.
The object of this study was to compare therapeutic effects of the formulation No. 2 noted above against petrolatum by itself as an active ingredient in treating pressure ulcers of shallow depth (Stage I & II). It is noted that petrolatum is the anhydrous base ointment component in the preferred embodiment of the formulation of the present invention.
A six-weeks randomized, double-blinded study was performed on twenty patients with Stage I or Stage II
ulcers. These patients received either Formulation Number 2 of the present invention in an Ointment or petrolatum, which served as a control.
The results showed complete resolution in a majority of pressure ulcers after a few weeks while only 1/3 of the pressure ulcers being treated with petrolatum resolved in the same period of time.
It was therefore concluded that preliminary results showed that the ointment of the present invention, as in Formulation No. 2, is a safe and effective treatment for Stage I & II pressure ulcers.
Previous treatments for pressure ulcers have included various topical medications, such as creams, ointments and hydrocolloid dressings; encouragement for movement; and cessation of all potentially confounding conditions that could perpetuate the ulcer. Topically applied medications include a variety of ingredients that fit into both prescription and non-prescription categories.
In this clinical study there was compared the therapeutic effectiveness of the ointment of the present invention, as a topically applied preparation with a novel combination of ingredients (see below), against its base component petrolatum in a scientifically controlled, randomized, double-blinded, control study.
The study consequently considered the ointment of the present invention as part of a regimen for treatment of other types of wounds such as Stage I & Stage II Pressure Ulcers.
The ingredients in the Formulation No. 2 ointment and their proposed pharmacological actions include: petrolatum, which helps control water loss from damaged skin by providing an occlusive protective layer while promoting normal skin barrier recovery (See footnote 9); liposome encapsulated live yeast cell derivative (LYCD) which promotes collagen synthesis through increased tissue oxygenation and cellular respiration,(see footnotes 3, 4, 5) shark liver oil which assists in skin penetration of other ingredients,(see footnote 6); catechins in green tea extract and vitamin E, which are free radical antioxidants and moderators of inflammation; benzyl alcohol, which has antimicrobial and local anesthetic properties(see footnotes 10, 11); ceramides, which are normal components of the stratum corneum, where they form a barrier to control moisture loss from the skin, and yucca extract which is used for its skin moisturizing properties.
Two separate study groups totaling twenty patients were conducted. Patients with Stage I or Stage II pressure ulcers were assigned twice daily (BID) treatment with formulation number 2 of the present invention, or with petrolatum by itself as an active ingredient. No other treatments were used.
The dispensing tubes containing formulation number 2 noted above, or petrolatum, were randomly numbered and their contents blinded from the patients, physicians and nursing staffs.
Patients with pressure ulcers having complex underlying etiologies such as venous stasis and severe diabetes were excluded from the study. Pressure ulcers were assessed for stage, size, erythema, and tenderness at the beginning and end of the study. Patients were monitored for any adverse effects, such as hypersensitivity, rash, or itching. Before and after photographs were taken of the pressure ulcers, the attending physicians were allowed to terminate patients from the study.
Nineteen patients having either Stage 1 or Stage II
Pressure Ulcers were entered into this study. Eighteen out of nineteen patients had one ulcer and one had two ulcers.
These nineteen patients were randomly placed in either the Group being treated with Formulation No. 2 of the present invention or the Petrolatum Group.
As noted in Table I here, ten patients totaling eleven ulcers were in the Group being treated with Formulation No.
2 of the present invention. Eight patients totaling nine ulcers finished the study. Two patients out of ten did not finish the study. One patient with a Stage I Ulcer was terminated because of medical conditions and the other with a Stage II Ulcer was discontinued because of non-improvement without deterioration. Nine of the remaining ulcers out of nine treated with the Formulation No. 2 of the present invention showed some level of improvement.
With respect to Stage I Pressure Ulcers: five of the nine pressure ulcers in this group were Stage I. Four out of five Stage I Ulcers were resolved by the end of the study. One out of five Stage I Ulcers was improved.
Four of the nine pressure ulcers were Stage II. One of the four Stage II Ulcers was resolved by the end of the study. Three of the four Stage II Ulcers were improved by the end of the study.
With respect to the Petrolatum Group, as in Table II
herein, nine patients totaling nine ulcers were in the Petrolatum Group. Two of the patients were terminated from the study because of worsening. Both had a Stage I Pressure Ulcer. Five of the remaining seven ulcers were Stage I.
Two of the remaining seven ulcers were Stage II.
Of the Stage I Pressure Ulcers: two out of five Stage I
Ulcers resolved by the end of the study. One out of five Stage I Ulcers showed no change. Two out of five Stage I
Ulcers worsened. concerning Stage II Pressure Ulcers: two out of two Stage II Pressure Ulcers worsened by the end of the study.
There were no complaints of itching, sensitivity or rash from either of the ointments.
Table I: Formulation No. 2 Ointment Patient Ulcer Stage Size (cm/diam) Erythema Tenderness Start 6 Weeks Start 6 Weeks Start 6 Weeks 1 One 1.5 Resolved Moderate Absent Non Applicable 2 One 1.0 Resolved Moderate Absent Non Applicable 3 One 0.7 Resolved Moderate Absent Non Applicable 4 One 2.0 0.3 Moderate Absent Non Applicable One 1.2 Terminated because of medical conditions 6 One 2.0 Resolved Moderate Absent Non Applicable 6 Two 1.1 0.7 Severe Mild Non Applicable 7 Two 3.0 1.0 Severe Mild Very 1V1ild 8 Two 4.0 1.5 Severe Mild Very Mild 9 Two 0.8 Resolved Moderate Absent Non Applicable Two 1.3 Discontinued because of non-improvement Table II: Petrolatum Control Group Patient Ulcer Stage Size (cm/diam) Erythema Tenderness Start 6 Weeks Start 6 Weeks Start 6 Weeks 1 One 1.2 Resolved Severe Moderate Mild 2 One 0.7 Resolved Moderate Absent N/A
3 One 0.7 0.7 Moderate Mild N/A
4 One 0.8 1.0 Mild Severe Not Tested One to Two 0.2 0.4 Mild Mild N/A
6 One 1.5 Terminated because of worsening 7 One 1.3 Terminated because of worsening 8 Two 0.4 1.0 Mild Moderate N/A
9 Two 4.0 6.0 Moderate Severe Very Mild 5 Conclusions:
The ointment of Formulation No. 2 of the present invention was found to be safe and effective in the treatment of pressure ulcers. It helped resolve the ulcers in a timely manner and did not have any side effects. It also was shown to be more effective than its base of petrolatum given the period of the study. This may be secondary to its additional wound healing components. The ointment of Formulation No. 2 was found therefore to also be useful in combination with other products for the treatment of pressure ulcers.
Footnote References:
(1) Chiarello, S. Skin Resurfacing: The Triple Technique, Cos. Derm. Oct. 1996:26-29.
.20 (2) Resnik, B., and Resnik, S. TCA Cream Skin Peel and Segmental Laser Resurfacing: Effective Combination Treatment of Rhytids and Solar Dyschromia. Cos.
Derm. 1999, 31-34 (3) Bentley JP, Hunt TK, Weiss JB, Taylor CM, Hanson, AN, Davies GH, Halliday BJ, Peptides from yeast cell derivative stimulate wound healing. Arch Surg. 1990 May; 125(5):641-64.
(4) Crowe MJ, McNeill RB, Schlemm DJ, Greenbaigh OH.
Topical application of yeast extract accelerates the wound healing of diabetic mice. J Burn Care Rehab.
1999 Mar-Apr; 2 (2):155-162 (5) Kaplan JZ. Acceleration of wound healing by live yeast cell derivative. Arch Surg. 19984;
119(9):1005-1008.
(6) Loftsson T, Peterson DS, Le Goffic F, Olafsson JH.
.15 Unsaturated glycerol monoethers as novel skin penetration enhancers. Pharmazie, 1997, June;
52(6):463-465 (7) Katiyar, S., Matsui, M., Ehmets, C., and Mulchter, H. Polyphenolic antioxidant (-)- epigallocatechin-3-gallate from green tea reduces UVB-induced inflammatory responses and infiltration of leukocytes in human skin. Photochem, Photobiol, Feb; 69(2):148-53.
(8) Fuchs, J., Huflejt, M., Rothfuss, L., Wilson, D., Carcamo, G., and Packer, L. Impairment of Enzymatic and Nonenzymatic Antioxidants in Skin by UVB
Irradiation, J. Invest. Dermatol. 93:769-773, 1989.
(9) Ghadially, R., Halkier-Scrensen, L., Elias, P., Effects of petrolatum on stratum corneum structure and function, J. Am. Acad. Dermatol 1992;26:387-96.
(10) Physicians Desk Reference. 1995;49 Edition: See:
Ativan Injection, p2644; Hexadrol Injection, p1751;
Vasotec Injection, p1648.
(11) Federal Register. 1990;55:31778.31780.
In another study of the use of Formulation No. 2 of the present invention for patients with Stage I & II pressure ulcers, a randomized pilot study in the nursing home was conducted by J. Shua-Haim MD, M. Sabo MD, J. Smith RNC at the Dept. of Outpatient Geriatrics, Geropsychiatry & Long Term Care Services, at the Jersey Shore Medical Center, NJ.
See footnote 12.
The purpose of this study was to investigate the efficacy of Formulation No. 2 of the present invention, as compared to the standard treatment for Stage I & II pressure ulcers in a nursing home facility (including sub-acute beds).
In this study, all newly admitted patients with Stage I
& II pressure ulcers, were randomized in two groups: a study group included persons treated with Formulation No. 2 in one study group and another control group including patients treated with conventional nursing home pressure ulcer protocol.
Formulation No. 2 was applied directly to the wound twice a day for Stage I & II ulcers. No dressing was applied. For Stage I, the control group was treated with normal sterile saline (NSS) followed by A&D ointment twice daily. Stage II ulcers were treated with NSS dressings twice daily and Replicare hydrocolloid wound dressing every 72 hours. All study patients were turned every 2 hours for pressure relief. All patients were evaluated daily during wound care rounds in the facility.
As a result, a total of 23 patients were evaluated.
Eleven patients were treated with Formulation No, 2 and 12 patients were in the control group.
Locations of pressure ulcers included: sacrum & Upper buttocks (7 occurrences), heel and ankle (8 occurrences), hip & upper thigh (5 occurrences), lateral calf (2 occurrences), back (1 occurrence). Three Stage I patients treated with Formulation No. 2 of the present invention had complete healing. The average treatment length for cure was days. Four Stage I patients in the control group showed the following: three healed, one did not heal after 14 5 days. The average treatment length to cure in control group was 10 days.
For Stage II wounds, results were collected after 14 days. Results for the eight patients treated with Formulation No. 2 were: three healed, three improved and two had no change. Results for the eight patients in the control group were: four healed, one improved, one had no change and two deteriorated. It was therefore concluded that treatment with Formulation No. 2 of the present invention for Stage I & II pressure ulcers showed a faster healing rate, with no deterioration, when compared to traditional nursing home treatment.
In another study of the use of Formulation No. 2 of the present invention for patients with Stage I & II pressure ulcers, a randomized pilot study in the nursing home was conducted by J. Shua-Haim MD, M. Sabo MD, J. Smith RNC at the Dept. of Outpatient Geriatrics, Geropsychiatry & Long Term Care Services, at the Jersey Shore Medical Center, NJ.
See footnote 12.
The purpose of this study was to investigate the efficacy of Formulation No. 2 of the present invention, as compared to the standard treatment for Stage I & II pressure ulcers in a nursing home facility (including sub-acute beds).
In this study, all newly admitted patients with Stage I
& II pressure ulcers, were randomized in two groups: a study group included persons treated with Formulation No. 2 in one study group and another control group including patients treated with conventional nursing home pressure ulcer protocol.
Formulation No. 2 was applied directly to the wound twice a day for Stage I & II ulcers. No dressing was applied. For Stage I, the control group was treated with normal sterile saline (NSS) followed by A&D ointment twice daily. Stage II ulcers were treated with NSS dressings twice daily and Replicare hydrocolloid wound dressing every 72 hours. All study patients were turned every 2 hours for pressure relief. All patients were evaluated daily during wound care rounds in the facility.
As a result, a total of 23 patients were evaluated.
Eleven patients were treated with Formulation No, 2 and 12 patients were in the control group.
Locations of pressure ulcers included: sacrum & Upper buttocks (7 occurrences), heel and ankle (8 occurrences), hip & upper thigh (5 occurrences), lateral calf (2 occurrences), back (1 occurrence). Three Stage I patients treated with Formulation No. 2 of the present invention had complete healing. The average treatment length for cure was days. Four Stage I patients in the control group showed the following: three healed, one did not heal after 14 5 days. The average treatment length to cure in control group was 10 days.
For Stage II wounds, results were collected after 14 days. Results for the eight patients treated with Formulation No. 2 were: three healed, three improved and two had no change. Results for the eight patients in the control group were: four healed, one improved, one had no change and two deteriorated. It was therefore concluded that treatment with Formulation No. 2 of the present invention for Stage I & II pressure ulcers showed a faster healing rate, with no deterioration, when compared to traditional nursing home treatment.
12) Shua-Haim, J., Sabo, M., Smith, J., and Ross, J.
Resurfix Treatment for Patients with Stage I and Stage II
Pressure Ulcers: A Randomized Pilot Study in the Nursing Home, Dept. of Outpatient Geriatric, Geropsychiatry, and Long Term Care Services, Jersey Shore Med. Center, N.J., Accepted for presentation at: The Gerontological Society of America, 52nd Annual Scientific Meeting: New Perspectives on Aging in the Post Genome Era, November 19-23, 1999, San Francisco Hilton and Towers, San Francisco, CA.
EXAMPLE 3:
Another evaluation was conducted of Formulation No. 2 as a novel wound care product in the elderly by B. Cook, E.
Gavanis and P. Lemke.
This study recognized that Formulation No. 2 of the present invention a multi component non-prescription wound care ointment product which has been used to enhance healing after trichloracetic acid skin peels, laser surgery and dermabrasion. (See footnote references 13 14).
This study had the objective of establishing the therapeutic effectiveness over a longer period of Formulation 2 in treating wounds commonly found in skilled nursing facilities. These include wounds of various degrees of severity such as simple inflammation, Pre-Stage I
Pressure Ulcers, Stage I Pressure Ulcers and Stage II
Pressure Ulcers. Formulation No. 2 was evaluated not only for the ability to reduce or heal the wound but also to maintain status after healing. Residents exhibiting various types of wounds were treated with Formulation No. 2 over a five-week period. The wounds were assessed for size and/or color on a weekly basis.
The study took place over a period of 5 weeks.
Residents exhibiting the various types of wounds considered for treatment with Formulation No. 2 were identified and grouped by a wound care nurse investigator in conjunction with the nursing staff of the facility where the study was performed.
Baseline wound status was assessed at the beginning of the study and once a week for the next 5 weeks by a wound care nurse investigator. This investigator also monitored mandatory wound care procedures performed by the nursing staff and adherence to the study protocol on a daily basis.
These included appropriate hydration, appropriate nutrition (dietary consult when necessary), turning and repositioning of residents, use of adaptive devices, use of wheel chair cushions, air mattresses, rolls, pillows, rest periods, use of pressure relieving overlays, cleansing of wounds (where appropriate), and application of Formulation No. 2 of the present invention.
Residents that were non-compliant were not be considered for this study. Residents that become non-compliant were eliminated from the study. Residents were placed into groups according to their type of wound(s).
For example, Group 1 included residents exhibiting areas of continual inflammation as evidenced by a pink color. Some of these areas were previous sites of excoriation or a Stage I Pressure Ulcer. These residents had experienced excoriation or had Stage I Pressure Ulcers in spite of preventative wound care procedures, including topical application of some wound care product. The protocol for treatment and evaluation for residents in this group included:
1) cleansing the inflamed area with soap and tepid water and patting the wound dry once daily or after each episode of incontinence, 2) applying Formulation No. 2 once daily or after each episode of incontinence, 3) monitoring on a daily basis other preventative procedures that were utilized as per existing nursing facility protocol and, 4) evaluating for color and change of inflamed areas initially and once a week for 4 weeks.
Group II included residents with pre-existing Stage I
Pressure Ulcers. The protocol for treatment and evaluation for residents in this group included:
1) cleansing the inflamed area with soap and tepid water and patting dry once daily or after each episode of incontinence, 2) application of Formulation No. 2 once daily or after each episode of incontinence, 3) monitoring on a daily basis other preventative procedures that were utilized as per existing nursing facility protocol, and, 4) evaluating for color and size of wound at the beginning of the study and once a week for 5 weeks.
Color of the wound was noted as "Red","Pink" or "Resolved ". The size of the wound was measured in length and width with an accuracy of 0.1 centimeters (cm). Areas of the body that were difficult to measure were noted by identifying the specific anatomical site.
Group III included residents with pre-existing Stage II
Pressure Ulcers. The protocol for treatment and evaluation for residents in this group included:
1) irrigating the wound gently without force with Saline Solution (NSS) and patting dry with sterile gauze pad(s) three times daily, 2) application of Formulation 2 to affected area and perimeter three times daily, 3) monitoring on a daily basis other preventative procedures that where utilized as per existing nursing facility protocol, and, 4) evaluating for color and size of wound at the beginning of the study and once a week for 5 weeks.
The size of the wound was measured in length and width and depth with an accuracy of 0.1 centimeters (cm).
With respect to results of this study in Example 3, the resident assessments were missed for week number 4 due to a death in the wound care nurse investigator's family. The protocols for cleansing of wounds and application of Formulation No. 2 were continued during this week without interruption.
The use of the term " resolved " in the study tables means that the skin had returned to pre wound status.
For Group 1 as to treatment and prevention of inflammation, eleven residents were entered into this group.
All residents entered the study with inflamed areas. Some of these areas were sites of previous excoriation or Stage I
Ulcers. Other residents had sites of recent inflammation.
Three residents had previous Stage I Ulcers of their heels.
Two residents had previous excoriation of areas of their buttock. Two residents had inflamed areas of their buttocks. One resident had an inflamed perineal and anal area. One resident had an inflamed perineal area. One resident had inflammation of the perineal and back of the neck areas. One resident had an inflamed groin area.
All residents' wounds had resolved by the end of the second week of treatment with Formulation No. 2 of the present invention and this continued for the next three weeks.
(See Table III Group I Treatment and Prevention of Inflammation Results.) For Group II as to treatment and prevention of Stage I
Pressure Ulcers, fourteen of the sixteen residents that entered this group finished the study. All had Stage I
Pressure Ulcers. Two of the sixteen residents did not finish the study. One resident expired. The other one developed severe edema secondary to venous stasis and the attending physician changed therapies. Thirteen of the fourteen residents that finished the study had one existing Stage I Ulcer. One of the fourteen residents had six existing Stage I Ulcers. This particular resident became non-compliant by refusing therapy throughout the first week, however, was not eliminated from the study due to insistence by the attending physician. This resident was compliant for the remainder of the study. The results for this resident's ulcers were analyzed separately. This patient had six Stage I Pressure Ulcers and refused therapy during week one.
Therapy started at week two on five of the six ulcers and continued uninterrupted for the rest of the study. One of the six ulcers under went biopsy during week two and was not treated this week as per physician request. This particular ulcer received uninterrupted treatment for the rest of the study and will be analyzed separately.
In Example 3, there were a total of thirteen Stage I
Ulcers treated with Formulation No. 2. There was some degree of improvement in all ulcers treated. Two of the thirteen ulcers were resolved after one week of therapy.
Six of the thirteen ulcers were resolved after two weeks of therapy. Seven of the thirteen ulcers were resolved after three weeks of therapy and eleven of the thirteen ulcers were resolved after five weeks of therapy.
The two ulcers that had not completely resolved by week five had shown marked improvement. One of these ulcers went from a red color and 72.0 cm2 size to a pink color and a 31 cm2 at the end of five weeks. The other went from a bright red color to a pink color after four weeks where it remained for week f ive .
One of the five ulcers was resolved after one week of therapy (noted under week 2 in Table IV). Five of the five ulcers were resolved after week two of therapy (noted under week 3 in Table IV).
One ulcer showed improvement after one week of therapy (noted under week 3 in Table IV). The size decreased from 16.0 cm2 to 12.2 cm2. The ulcer showed further reduction three weeks of therapy (noted under week five in Table IV).
The size of the ulcer decreased from 16.0 cm2 at baseline to 7.5 cm2. (See Table IV: Group II Treatment and Prevention of Stage I Pressure Ulcers Results.) Group III: As to treatment and prevention of Stage II
Pressure Ulcers, six of the nine residents that entered this group finished the study. All residents entered with one Stage II Pressure Ulcer. Three of the nine residents were eliminated from the study. Two of the residents were non-compliant because of refusing to accept therapy and one resident was transferred to a hospital. Five of the six residents received uninterrupted treatment for the remaining period of the study. One of the residents was in the hospital for study week 2 and was analyzed separately.
Results at the end of week 1 of therapy: Two of the five ulcers remained the same size. Three of the five ulcers decreased in size.
Results at the end of week 2 of therapy: One out of five remained the same size. Four (4) out of five ulcers decreased in size.
Results at the end of week 3 of therapy: Three out of five ulcers decreased in size. Two out of five ulcers were resolved.
Results at the end of week 5 of therapy: One out of five ulcers remained the same size. Four (4) out of five were resolved.
The Results of the hospitalized patient are as follows: The ulcer was decreased at the end of week 1. The results were not available for week 2. The ulcer was treated but remained the same size for week 3. The ulcer was decreased in size for week 5. (See Table V: Group III Treatment and Prevention of Stage II Pressure Ulcers Results.) Table III
a Group I Results: Treatment and Prevention of Inflammation Patient Description Baseline Week 1 Week 2 Week 3 Week 5 Number Assessment 1 Groin Pink Pink Resolved Resolved Resolved 2 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels 3 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels 4 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels Recurrent Pink Pink Resolved Resolved Resolved Excoriation to Buttocks 6 Recurrent Pink Pink Resolved Resolved Resolved Excoriation to Buttocks 7 Perineal and Pink Pink Resolved Resolved Resolved Anal areas 8 Perineal area Pink Pink Resolved Resolved Resolved 9 Back of neck Pink Pink Resolved Resolved Resolved and perineal areas Buttocks Pink Pink Resolved Resolved Resolved 11 Buttocks Pink Pink Resolved Resolved Resolved Table IV
Group II: Treatment and Prevention of Stage I Pressure Ulcers Patient Anatomical Baseline Color or Therapy Therapy Therapy Therapy Number Site of the Size (cm 0.0) of Week 1 Week 2 Week 3 Week 5 Ulcer Ulcer Length (L) and Width 1 Bilateral Red Pink Resolved Resolved Resolved Heels 2 8.0L x 9.0W 8.OL x 9.0W 7.OL x 8.0W 7.OL x 7.0W 6.2L x 5.0W
3 Bilateral Red Red Resolved Pink Resolved Groin 4 Bilateral Red Red Resolved Resolved Resolved Inner Thighs Right Heel 1.5L x 1.5W 1.5L x 1.5W 1.OL x 1.0W Resolved Resolved 6 Bilateral 10.OL x 7.0W Resolved Resolved Resolved Resolved Buttocks 7 Upper 5.OL x 5.0W Refused 4.2L x 4.4W Resolved Resolved Posterior Therapy Knees 5.O1L x 5.OW
7 Right Lower 4.OL x 4.0W Refused Biopsy 3.4L x 3.6W 3.OL x 2.5W
Leg Therapy Taken 4.01L x 4.0W
7 Left Lower 3.OL x 4.0W Refused Resolved Resolved Resolved Posterior Therapy 3.OL x 4.0W
7 Left Calf 2.OL x 2.0W Refused 2.OL x 2.0W Resolved Resolved Therapy 2.OL x 2.0W
7 Left Upper 5.OL x 4.0W Refused 4.OL x 2.0W Resolved Resolved Thigh Therapy 5.OL x 4.0W
7 Left Outer 3.OL x 4.0W Refused 2.OL x 2.0W Resolved Resolved Knee Therapy 3.OL x 4.0W
8 Perineal Red Pink Pink Resolved Resolved Area 9 Under Red Resolved Resolved Resolved Resolved Breasts 6.OL x 5.0W 6.OL x 5.0W 4.OL x 5.0W 4.OL x 4.0W Resolved Penis, Bright Red Red Pink Pink Pink 11 Scrotum and .
Both inner Thighs 12 11.OL x 8.OW 10.0L x 8.0W 11.OL x 3.8L x 5.OW Resolved 5.0W
Resurfix Treatment for Patients with Stage I and Stage II
Pressure Ulcers: A Randomized Pilot Study in the Nursing Home, Dept. of Outpatient Geriatric, Geropsychiatry, and Long Term Care Services, Jersey Shore Med. Center, N.J., Accepted for presentation at: The Gerontological Society of America, 52nd Annual Scientific Meeting: New Perspectives on Aging in the Post Genome Era, November 19-23, 1999, San Francisco Hilton and Towers, San Francisco, CA.
EXAMPLE 3:
Another evaluation was conducted of Formulation No. 2 as a novel wound care product in the elderly by B. Cook, E.
Gavanis and P. Lemke.
This study recognized that Formulation No. 2 of the present invention a multi component non-prescription wound care ointment product which has been used to enhance healing after trichloracetic acid skin peels, laser surgery and dermabrasion. (See footnote references 13 14).
This study had the objective of establishing the therapeutic effectiveness over a longer period of Formulation 2 in treating wounds commonly found in skilled nursing facilities. These include wounds of various degrees of severity such as simple inflammation, Pre-Stage I
Pressure Ulcers, Stage I Pressure Ulcers and Stage II
Pressure Ulcers. Formulation No. 2 was evaluated not only for the ability to reduce or heal the wound but also to maintain status after healing. Residents exhibiting various types of wounds were treated with Formulation No. 2 over a five-week period. The wounds were assessed for size and/or color on a weekly basis.
The study took place over a period of 5 weeks.
Residents exhibiting the various types of wounds considered for treatment with Formulation No. 2 were identified and grouped by a wound care nurse investigator in conjunction with the nursing staff of the facility where the study was performed.
Baseline wound status was assessed at the beginning of the study and once a week for the next 5 weeks by a wound care nurse investigator. This investigator also monitored mandatory wound care procedures performed by the nursing staff and adherence to the study protocol on a daily basis.
These included appropriate hydration, appropriate nutrition (dietary consult when necessary), turning and repositioning of residents, use of adaptive devices, use of wheel chair cushions, air mattresses, rolls, pillows, rest periods, use of pressure relieving overlays, cleansing of wounds (where appropriate), and application of Formulation No. 2 of the present invention.
Residents that were non-compliant were not be considered for this study. Residents that become non-compliant were eliminated from the study. Residents were placed into groups according to their type of wound(s).
For example, Group 1 included residents exhibiting areas of continual inflammation as evidenced by a pink color. Some of these areas were previous sites of excoriation or a Stage I Pressure Ulcer. These residents had experienced excoriation or had Stage I Pressure Ulcers in spite of preventative wound care procedures, including topical application of some wound care product. The protocol for treatment and evaluation for residents in this group included:
1) cleansing the inflamed area with soap and tepid water and patting the wound dry once daily or after each episode of incontinence, 2) applying Formulation No. 2 once daily or after each episode of incontinence, 3) monitoring on a daily basis other preventative procedures that were utilized as per existing nursing facility protocol and, 4) evaluating for color and change of inflamed areas initially and once a week for 4 weeks.
Group II included residents with pre-existing Stage I
Pressure Ulcers. The protocol for treatment and evaluation for residents in this group included:
1) cleansing the inflamed area with soap and tepid water and patting dry once daily or after each episode of incontinence, 2) application of Formulation No. 2 once daily or after each episode of incontinence, 3) monitoring on a daily basis other preventative procedures that were utilized as per existing nursing facility protocol, and, 4) evaluating for color and size of wound at the beginning of the study and once a week for 5 weeks.
Color of the wound was noted as "Red","Pink" or "Resolved ". The size of the wound was measured in length and width with an accuracy of 0.1 centimeters (cm). Areas of the body that were difficult to measure were noted by identifying the specific anatomical site.
Group III included residents with pre-existing Stage II
Pressure Ulcers. The protocol for treatment and evaluation for residents in this group included:
1) irrigating the wound gently without force with Saline Solution (NSS) and patting dry with sterile gauze pad(s) three times daily, 2) application of Formulation 2 to affected area and perimeter three times daily, 3) monitoring on a daily basis other preventative procedures that where utilized as per existing nursing facility protocol, and, 4) evaluating for color and size of wound at the beginning of the study and once a week for 5 weeks.
The size of the wound was measured in length and width and depth with an accuracy of 0.1 centimeters (cm).
With respect to results of this study in Example 3, the resident assessments were missed for week number 4 due to a death in the wound care nurse investigator's family. The protocols for cleansing of wounds and application of Formulation No. 2 were continued during this week without interruption.
The use of the term " resolved " in the study tables means that the skin had returned to pre wound status.
For Group 1 as to treatment and prevention of inflammation, eleven residents were entered into this group.
All residents entered the study with inflamed areas. Some of these areas were sites of previous excoriation or Stage I
Ulcers. Other residents had sites of recent inflammation.
Three residents had previous Stage I Ulcers of their heels.
Two residents had previous excoriation of areas of their buttock. Two residents had inflamed areas of their buttocks. One resident had an inflamed perineal and anal area. One resident had an inflamed perineal area. One resident had inflammation of the perineal and back of the neck areas. One resident had an inflamed groin area.
All residents' wounds had resolved by the end of the second week of treatment with Formulation No. 2 of the present invention and this continued for the next three weeks.
(See Table III Group I Treatment and Prevention of Inflammation Results.) For Group II as to treatment and prevention of Stage I
Pressure Ulcers, fourteen of the sixteen residents that entered this group finished the study. All had Stage I
Pressure Ulcers. Two of the sixteen residents did not finish the study. One resident expired. The other one developed severe edema secondary to venous stasis and the attending physician changed therapies. Thirteen of the fourteen residents that finished the study had one existing Stage I Ulcer. One of the fourteen residents had six existing Stage I Ulcers. This particular resident became non-compliant by refusing therapy throughout the first week, however, was not eliminated from the study due to insistence by the attending physician. This resident was compliant for the remainder of the study. The results for this resident's ulcers were analyzed separately. This patient had six Stage I Pressure Ulcers and refused therapy during week one.
Therapy started at week two on five of the six ulcers and continued uninterrupted for the rest of the study. One of the six ulcers under went biopsy during week two and was not treated this week as per physician request. This particular ulcer received uninterrupted treatment for the rest of the study and will be analyzed separately.
In Example 3, there were a total of thirteen Stage I
Ulcers treated with Formulation No. 2. There was some degree of improvement in all ulcers treated. Two of the thirteen ulcers were resolved after one week of therapy.
Six of the thirteen ulcers were resolved after two weeks of therapy. Seven of the thirteen ulcers were resolved after three weeks of therapy and eleven of the thirteen ulcers were resolved after five weeks of therapy.
The two ulcers that had not completely resolved by week five had shown marked improvement. One of these ulcers went from a red color and 72.0 cm2 size to a pink color and a 31 cm2 at the end of five weeks. The other went from a bright red color to a pink color after four weeks where it remained for week f ive .
One of the five ulcers was resolved after one week of therapy (noted under week 2 in Table IV). Five of the five ulcers were resolved after week two of therapy (noted under week 3 in Table IV).
One ulcer showed improvement after one week of therapy (noted under week 3 in Table IV). The size decreased from 16.0 cm2 to 12.2 cm2. The ulcer showed further reduction three weeks of therapy (noted under week five in Table IV).
The size of the ulcer decreased from 16.0 cm2 at baseline to 7.5 cm2. (See Table IV: Group II Treatment and Prevention of Stage I Pressure Ulcers Results.) Group III: As to treatment and prevention of Stage II
Pressure Ulcers, six of the nine residents that entered this group finished the study. All residents entered with one Stage II Pressure Ulcer. Three of the nine residents were eliminated from the study. Two of the residents were non-compliant because of refusing to accept therapy and one resident was transferred to a hospital. Five of the six residents received uninterrupted treatment for the remaining period of the study. One of the residents was in the hospital for study week 2 and was analyzed separately.
Results at the end of week 1 of therapy: Two of the five ulcers remained the same size. Three of the five ulcers decreased in size.
Results at the end of week 2 of therapy: One out of five remained the same size. Four (4) out of five ulcers decreased in size.
Results at the end of week 3 of therapy: Three out of five ulcers decreased in size. Two out of five ulcers were resolved.
Results at the end of week 5 of therapy: One out of five ulcers remained the same size. Four (4) out of five were resolved.
The Results of the hospitalized patient are as follows: The ulcer was decreased at the end of week 1. The results were not available for week 2. The ulcer was treated but remained the same size for week 3. The ulcer was decreased in size for week 5. (See Table V: Group III Treatment and Prevention of Stage II Pressure Ulcers Results.) Table III
a Group I Results: Treatment and Prevention of Inflammation Patient Description Baseline Week 1 Week 2 Week 3 Week 5 Number Assessment 1 Groin Pink Pink Resolved Resolved Resolved 2 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels 3 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels 4 Recurrent Pink Pink Resolved Resolved Resolved Stage I of heels Recurrent Pink Pink Resolved Resolved Resolved Excoriation to Buttocks 6 Recurrent Pink Pink Resolved Resolved Resolved Excoriation to Buttocks 7 Perineal and Pink Pink Resolved Resolved Resolved Anal areas 8 Perineal area Pink Pink Resolved Resolved Resolved 9 Back of neck Pink Pink Resolved Resolved Resolved and perineal areas Buttocks Pink Pink Resolved Resolved Resolved 11 Buttocks Pink Pink Resolved Resolved Resolved Table IV
Group II: Treatment and Prevention of Stage I Pressure Ulcers Patient Anatomical Baseline Color or Therapy Therapy Therapy Therapy Number Site of the Size (cm 0.0) of Week 1 Week 2 Week 3 Week 5 Ulcer Ulcer Length (L) and Width 1 Bilateral Red Pink Resolved Resolved Resolved Heels 2 8.0L x 9.0W 8.OL x 9.0W 7.OL x 8.0W 7.OL x 7.0W 6.2L x 5.0W
3 Bilateral Red Red Resolved Pink Resolved Groin 4 Bilateral Red Red Resolved Resolved Resolved Inner Thighs Right Heel 1.5L x 1.5W 1.5L x 1.5W 1.OL x 1.0W Resolved Resolved 6 Bilateral 10.OL x 7.0W Resolved Resolved Resolved Resolved Buttocks 7 Upper 5.OL x 5.0W Refused 4.2L x 4.4W Resolved Resolved Posterior Therapy Knees 5.O1L x 5.OW
7 Right Lower 4.OL x 4.0W Refused Biopsy 3.4L x 3.6W 3.OL x 2.5W
Leg Therapy Taken 4.01L x 4.0W
7 Left Lower 3.OL x 4.0W Refused Resolved Resolved Resolved Posterior Therapy 3.OL x 4.0W
7 Left Calf 2.OL x 2.0W Refused 2.OL x 2.0W Resolved Resolved Therapy 2.OL x 2.0W
7 Left Upper 5.OL x 4.0W Refused 4.OL x 2.0W Resolved Resolved Thigh Therapy 5.OL x 4.0W
7 Left Outer 3.OL x 4.0W Refused 2.OL x 2.0W Resolved Resolved Knee Therapy 3.OL x 4.0W
8 Perineal Red Pink Pink Resolved Resolved Area 9 Under Red Resolved Resolved Resolved Resolved Breasts 6.OL x 5.0W 6.OL x 5.0W 4.OL x 5.0W 4.OL x 4.0W Resolved Penis, Bright Red Red Pink Pink Pink 11 Scrotum and .
Both inner Thighs 12 11.OL x 8.OW 10.0L x 8.0W 11.OL x 3.8L x 5.OW Resolved 5.0W
13 Groin and Red Red Pink Resolved Resolved Fold 14 Left Hi 2.OL x 8.0W 11.OL x 6.0W Resolved Resolved Resolved Table V
Group III: Treatment and Prevention of Stage II Pressure Ulcers Patient Anatomical Baseline Color or Therapy Therapy Therapy Therapy Number Site of the Size (cm 0.0) of Week 1 Week 2 Week 3 Week 5 Ulcer Ulcer Length (L) and Width (W) and Depth 1 Sacral 1.OL x 1.5W x 0.8L x 1.5W Hospitalized 0.8L x 1.0W 0.2L x 0.5W
O.1D x 0.1D x 1.OD x 0.1D
2 Left 1.OL x 1.OW x 1.OL x 1.OW 0.5L x 0.4W 0.3L x 0.1 W Resolved Buttock 0.1D x 0.1D x 0.1D x 0.1D
3 Right 1.5L x 1.7W x 1.5L x 1.7W 1.4L x 1.5W 1.3L x 1.4W Resolved Buttock 0.1D x O.1D x O.1D x 0.1D
4 Sacral 2.OL x 2.0W x 2.OL x 2.5W 1.5L x 1.7W Resolved Resolved 0.4D x 0.2D x 0.1D
5 LeftHip 6.5Lx5.5Wx 4.5Lx2.3W 4.OLx2.3W 3.7Lx2.OW 3.OLx2.OW
(Old incision 0.1D x 0.1D x 0.1D x 0.1D x 0.1D
Site) 6 Left H'ip 0.3L x 0.3W x 0.3L x 0.1W 0.1L x 0.1W Resolved Resolved 0.5D x O.1D x O.1D
As a result of the Example 3 study noted in Tables III, IV and V. Formulation No. 2 of the present invention was shown to be therapeutically effective for prevention and treatment of inflammation, Stage I Pressure Ulcers, and as to Stage II Pressure Ulcers, Formulation No. 2 either resolved (returned the skin to pre wound status), prevented further development, or markedly improved the wounds treated during this five week study.
A
The study noted that treatment and prevention of wounds requires not only the application of an appropriate medication, such as Formulation No. 2, but just as importantly, assurance that all other underlying potentially confounding situations such as diet, hydration, repositioning, use of appliances, and etc. are controlled.
It was found in this study that Formulation No. 2 was not only therapeutically effective but was also very easy to apply and remove. This is especially important in elderly patients whose skin integrity may be greatly reduced and application and removal of topical medications may sometimes cause skin tears.
References:
13) Chiarello, S. Skin Resurfacing: The Triple Technique, Cos. Derm. Oct 1996:26-29 14) Resnik, B., and Resnik, S. TCA Cream Skin Peel and Segmental Laser Resurfacing: Effective Combination Treatment of Rhytids and Solar Dyschromia. Cos. Derm. 1999, Other changes to the present invention may be made without departing from the spirit or scope thereof, when read in conjunction with the appended claims.
Group III: Treatment and Prevention of Stage II Pressure Ulcers Patient Anatomical Baseline Color or Therapy Therapy Therapy Therapy Number Site of the Size (cm 0.0) of Week 1 Week 2 Week 3 Week 5 Ulcer Ulcer Length (L) and Width (W) and Depth 1 Sacral 1.OL x 1.5W x 0.8L x 1.5W Hospitalized 0.8L x 1.0W 0.2L x 0.5W
O.1D x 0.1D x 1.OD x 0.1D
2 Left 1.OL x 1.OW x 1.OL x 1.OW 0.5L x 0.4W 0.3L x 0.1 W Resolved Buttock 0.1D x 0.1D x 0.1D x 0.1D
3 Right 1.5L x 1.7W x 1.5L x 1.7W 1.4L x 1.5W 1.3L x 1.4W Resolved Buttock 0.1D x O.1D x O.1D x 0.1D
4 Sacral 2.OL x 2.0W x 2.OL x 2.5W 1.5L x 1.7W Resolved Resolved 0.4D x 0.2D x 0.1D
5 LeftHip 6.5Lx5.5Wx 4.5Lx2.3W 4.OLx2.3W 3.7Lx2.OW 3.OLx2.OW
(Old incision 0.1D x 0.1D x 0.1D x 0.1D x 0.1D
Site) 6 Left H'ip 0.3L x 0.3W x 0.3L x 0.1W 0.1L x 0.1W Resolved Resolved 0.5D x O.1D x O.1D
As a result of the Example 3 study noted in Tables III, IV and V. Formulation No. 2 of the present invention was shown to be therapeutically effective for prevention and treatment of inflammation, Stage I Pressure Ulcers, and as to Stage II Pressure Ulcers, Formulation No. 2 either resolved (returned the skin to pre wound status), prevented further development, or markedly improved the wounds treated during this five week study.
A
The study noted that treatment and prevention of wounds requires not only the application of an appropriate medication, such as Formulation No. 2, but just as importantly, assurance that all other underlying potentially confounding situations such as diet, hydration, repositioning, use of appliances, and etc. are controlled.
It was found in this study that Formulation No. 2 was not only therapeutically effective but was also very easy to apply and remove. This is especially important in elderly patients whose skin integrity may be greatly reduced and application and removal of topical medications may sometimes cause skin tears.
References:
13) Chiarello, S. Skin Resurfacing: The Triple Technique, Cos. Derm. Oct 1996:26-29 14) Resnik, B., and Resnik, S. TCA Cream Skin Peel and Segmental Laser Resurfacing: Effective Combination Treatment of Rhytids and Solar Dyschromia. Cos. Derm. 1999, Other changes to the present invention may be made without departing from the spirit or scope thereof, when read in conjunction with the appended claims.
Claims (11)
1. A topical composition for treating bedsores comprising a liposome encapsulated live yeast cell derivative (LYCD) provided in a substantially anhydrous pharmaceutically acceptable base.
2. The composition as in claim 1, wherein said live yeast cell derivative (LYCD) is provided in an amount of at least 200 biologically active units per 100 grams of the composition.
3. The composition as in claim 1, wherein said live yeast cell derivative (LYCD) is provided in an amount of about 600 biologically active units per 100 grams of the composition.
4. The composition as in any one of claims 1, 2 or 3, wherein said substantially anhydrous base comprises, petrolatum as an occlusion enhancing medium for the skin.
5. The composition as in any one of claims 1 to 4, further comprising a skin enhancing penetration solvent.
6. The composition as in claim 5, wherein said solvent is shark liver oil.
7. The composition for treating bedsores as in any one of claims 1 to 6, wherein the following components are listed by percentage weight of the total composition:
Ingredient Range (%w/w) Petrolatum 10-99.5%
Live Yeast Cell Derivative (LYCD) at least 200 biologically active units per 100 grams of the composition.
Ingredient Range (%w/w) Petrolatum 10-99.5%
Live Yeast Cell Derivative (LYCD) at least 200 biologically active units per 100 grams of the composition.
8. The composition for treating bedsores as in any one of claims 1 to 6, wherein the following components are listed by percentage weight of the total composition:
Ingredient Range (%w/w) Petrolatum 87.5%
Live Yeast Cell Derivative (LYCD) at last 600 biologically active units per 100 grams of the composition.
Ingredient Range (%w/w) Petrolatum 87.5%
Live Yeast Cell Derivative (LYCD) at last 600 biologically active units per 100 grams of the composition.
9. Use of a topical composition for treating bedsores, said composition comprising an effective amount of a liposome encapsulated live yeast cell derivative (LYCD) provided in a substantially anhydrous pharmaceutically acceptable base.
10. The use according to claim 9, wherein the composition is as defined in any one of claims 2 to 8.
11. The use according to claim 9, wherein said derivative is provided in an amount of at least 200 biologically active units per 100 grams of the composition, said composition having petrolatum as an occlusive agent, and a solvent, and wherein said composition is applied in a pharmaceutically accepted vehicle.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16489599P | 1999-11-10 | 1999-11-10 | |
| US60/164,895 | 1999-11-10 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2325337A1 CA2325337A1 (en) | 2001-05-10 |
| CA2325337C true CA2325337C (en) | 2009-12-15 |
Family
ID=22596565
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002325337A Expired - Fee Related CA2325337C (en) | 1999-11-10 | 2000-11-09 | Use of live yeast cell derivative to treat bed sore pressure ulcers |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2325337C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030198682A1 (en) * | 2002-02-12 | 2003-10-23 | Gruber James V. | Composition and method for protecting labile active components during high temperature drying |
| US10279007B2 (en) * | 2010-11-15 | 2019-05-07 | Oxygenetix Institute, Inc. | Topical treatment method for healing wounds, disinfecting, covering and concealing the wound until healing occurs |
-
2000
- 2000-11-09 CA CA002325337A patent/CA2325337C/en not_active Expired - Fee Related
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| Publication number | Publication date |
|---|---|
| CA2325337A1 (en) | 2001-05-10 |
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