CA2185583A1 - Topical composition for burn relief and method of use - Google Patents

Abstract

A topical composition for treatment of skin bum, comprising salt and lemon juice, preferably in proportions sufficient to form a pasty composition. A method for treatment of skin burn using this topical composition is also disclosed.

Description

W0 95/24829 ~ 1 3 5 5 8 3 PcTfUSs~2787 TO~?ICA1 COl!ql?OSITION FO~ 131~N
:E~13~I~F ~ND MI5THOD OF ~S~

R ~ r~ rl 0f thr Tnyr~nt;nn Fi~ 1 of thr~ InvRnti nn This invention relates to topical compositions and methods of using them for reducing pain and promoting healing of burn related wounds.
r;ntinn nf thr P--lAtr~rl Art Skin is the largest organ of the body, and performs a critical function as a protective waterproof covering for the entire body. Skin contains many sensory nerve endings which keep U6 informed regarding our external environment, as well as myriad blood vessels which aid in temperature regulation. Skin is modified for different areas of the body, and forms a thick, heavy epidermis on the palms of the hand and palms of the feet, as compared to the thin layer over the rest of the body.
Skin is composed of two layers. The outer layer, the epidermis, contains several layers of stratified epithelial cells, with increasing amounts of protein keratin in the outermost layers. This a- r~n~ ~ decreases excessive water loss from the skin surface and renders the body relatively insensitive to minor abrasions and in juries .
Furthermore, the epidermis has a limited distribution of nerve endings and is devoid of blood vessels so that one 2 1 8 5 5 8 3 PCr/US94/02787 o can shave off several layers of cells without blood loss or pain .
The stratum germinativum is the innermost layer of the epidermis and contain6 several layers of cells undergoing mitosis. The stratum corneum is the outermost layer of the epidermis, and makes up most of the epidermis. The f lattened, dehydrated cells of the stratum corneum are O~llaL~ ly flaking off, often in irregular patches, for instance, after sunburn, and are replaced by cells migrating towards the surface from the deeper epidermal layers. The dead cells provide an effective covering which protects the entire body against water loss and is also a poor c~ tor of heat. Thus, brief contact with a hot object does not burn the skin.
However, longer contact with hot objects can result in ~ ;Lion of skin and in vascular damage. While the body is capable of regenerating skin and healing minor burn related wounds without medical attention, more substantial burns require f irst-aid or even medical attention .
Of the injuries to the skin, burns are perhaps the most painful, and so treatment of skin burns involves not only LL~:a, L to expedite healing, but also treatment to reduce or control pain. Skin injuries are difficult to treat due to the constant ~X~ODULe of the skin to the dehydrating effect of the aerobic environment and to ~ ~. t. A further concern with burn related wounds is the increased susceptibility to infection. Severe skin W095i24829 2 1 8 ~i 5 ~ ;~; YCTlUSg4l0271l7 burns largely ~liminiqh the protective r- ~niF~nq of skin against infection, and leave necrotic tissue.
In the past, ekin burns have been covered with dressings fiuch as salves, vaseline, and fibrous or synthetic polymer balld~g~s, in an effort to prevent ~el.ydL~tion, protect against heat loss, prevent bacterial inf ection, and to maintain a moist environment about the wound to facilitate debridement. Conventional bandages are made of materials such as natural or synthetic fibers.
One problem with such conventional covers is that, as the skin exudes serum an pus, this exudate is absorbed by the bandage. This proteinaceous material provides a culture medium for bacteria. Further, as the exudate hardens, the bandage is likely to become adhered to the skin. As the bandage is removed, the scab is also frequently removed.
This can be t~L~ -ly painful.
Various have been developed as an alternative to, or f or use with, bandages . For example, United States Patent 85,385 ~llughes) teaches a medicinal c, ' suitable ~or treatment of skin ~ i 1- Ls including burns, which composition is made by mixing and simmering cider-vinegar, molasses, spirits of turpentine, salt, saltpeter, oil of vLtriol, and olive oil.
United States Patent 321,839 (Neuer) teaches a medicinal ~ nrl for treatment of skin wounds, comprising thymol, boracic acid, potassium chloride, sodium chloride, and oil of wintergreen.

Wo 95l24829 PcrluS94102787 2 1 85~83 ~
United States Patent 390,534 (Tnml ;ncon) teaches a lotion for L~i L of sores, wounds and the like, comprising water, gambier extract, salt, and sulphuric acid .
Recently; uv~ -nts have been made in hAnfl~Qq by the provision of a thin perforated non-adhering plastic f ilm between the bandage and the wound . However, exudate ~ ; n; n~ between the plastic and the wound, and this provides an excellent medium for bacterial proliferation.

Even more recently a new class of b~n~ c has been developed of natural or synthetic materials which are water swellable, i.e., they absorb water without dissolving in water .
r~ ry of these is United States Patent 4,732,755 (Grana), which teaches the application of sodium polyacrylate powder as a dressing over the skin burn area, and wetting the powder such as by spraying with distilled water, until the powder becomes moist. ~he outer wetted surface of the moistened powder dries to form a parchment like surface, and may remain in place for 2-3 weeks.
United States Patent 4,837,019 (Georgalas et al. ) teaches a skin treatment composition f or treating burned skin, which composition is capable of counteracting moisture 10s8 and promote healing, and which comprises a moisturizing ' L formed of polyglycerylmethacrylate, WO 95/Z4829 2 1 8 5 5 8 ~ PCTIUS94102787 glycerine, allantoin, panthenol, amino acid complex, and ~ibronectin .
United States Patent 5,009,890 (DiPippo) discloses a burn LL~Gai ~ product in the form of a water-soluble, bio-degradable gel, the active ingredients of which are water and Tea Tree Blend. A gum material is used to maintain the water and Tea Tree Blend in a gel state.
A number of compositions have been developed for the LLG~ L of skin burns, but these compositions contain medications which are expensive and not readily available.
In each case ri;~:r11~fi~cl above, the composition is either expensive or is formulated from ingredients which is not readily available. Further, the application of various of the prior art compositions to a burn may require medical training and constant attention. Further, various patients may have reactions to certain of the non-naturally occurring pharmaceutical compositions.
In view of the foregoing, it is an object of the present invention to provide a topical composition for LLG`a; L of skin burns which eliminates or minimizes the ab<,~ G - Lioned and other problems, limitations and disadvc.rlLayGs typically associated with conventional topical compositions, and to provide a topical composition which is in~yrF~n~ive~ easily obtAinAhll~, simple to manufacture, easy to apply and use, reliable, storage-stable, and which does not n~ Arily require medical t~aini~g to use.

Wo 95/24829 ~ ~ 8 5 ~ 8 3 PCr/US94/02787 of th~ Tnvention After extensive investigation and experimentation, the present inventor ha6 disuuvt:~d that the objects of the invention can be simply, eloquently, and in~yrnn~ively F~ hed by a topical composition for the LL~ai L of burns comprising a mixture of one part lemon juice to sufficient salt to form a pasty, plastic, formable composition (usually about 2 to 2.5 parts salt), which topical composition can be applied directly to the affected area of the skin without the need for complicated medical diagnosis, ~Le:L~edi L, and monitoring. The composition stops pain on contact, prevents blistering, causes the tissue to remain elastic, promotes healing and ~Le~v~ tS
infection .

tni 1~ ption of the Invention The present invention more specifically concerns a topical composition and method for treatment of traumatized skin, i.e., thermal burns ranging from mild in jury to extensive necrosis of the skin and/or underlying tissues.
The composition and method not only expedites the healing of f irst and second degree burns, which are normally capable of healing without scarring, but also promotes the healing of third degree burns without scar tissue.
The ability to heal third degree burns without scarring is important not only for the treatment of accidental burns, but also in the LL~ai L of intentional WO 95124829 2 1 8 5 5 8 3 PcrnJS94102787 .
burns, such as thermal burn6 for destruction of birthmarks, disfiguring scars resulting from earlier injury, and the like .
The composition of the present invention is capable of application to mammals in general and humans in particular.
This invention is particularly useful when applied to traumatized tissue immediately after injury, but may also be applied one or more days after injury. Healing begins promptly upon application of the composition to the affected area, and the duration of healing will vary, ~p~n~iin~ upon the extent of the injury, from a few days to a few weeks.
The salt patch may be removed and changed without fear of adhesion to the skin as in the case of f abric-based b~n~ e~. Alternatively, the salt patch may remain in place until sloughed off by the growth of new tissue under the new tissue under the bottom layer of the protective layer .
In addition to reducing pain and promoting healing, it is believed that both the salt Cu~ Lr ~tion in the patch and the citrus juice or citric acid thereof act as excellent anti-bacterial and anti-viral agents, preventing infection of the skin.
It has been known to use various citrus juices in relationship with the skin. For example, United States Patent 5,083,208 teaches a method of massage with 10-15%
lemon oil and 85-90% lemon juice, but cautions that the Wos5/24829 2 1 8 5 5 ~ 3 PCT/US94/02787 astringency of the lemon juice may cause minor irritation to abrasions and open wounds, and ~ _ ' f lushing wounds with water in case the composition contacts wounds.
United States Patent 5 ,152, 000 teaches a hair grower consisting of extract of skin of naval orange, skin of iyokan (Citrus iyo), skin of hassaku (Citrus hassaku), the skin of sweet summer orange, the skin of lemon, the skin of mandarin orange, and aloe, all of which extracts are prepared by extracting with sake.
An investigation of the virucidal activity of organic acids, including citric acids, against various groups of viruses can be found in Poli et S~l "Virucidal Activity of Organic Acids", Fd. Chem. ( 1979 ), pages 251-258 . The organic acids being tested are mixed into a viral suspension. There is no suggestion for combination with salt, and there is no suggestion that organic acids can be applied to skin burn to prevent infection and promote healing .
On the other hand, it is known to use salt in LL ~ of various conditions of the skin . United States Patent 711,263 (Robertson) discloses a composition for remedy of ~ ~e~PF; of the skin, comprising magnesium chloride, sodium chloride, potassium chloride, magnesium sulfate, gnP~ n bromide, and acetic acid.
United States Patent 3,579,632 (Sonnen) teaches a hair and scalp ~L ~ with a sodium chloride thick viscous agueous slurry.

-wo 9~/2482g 2 i 8 5 5 8 3 PCTIU~94102787 United States Patent 3, 574, 854 describes theapplication of a composition containing a solution of 10 to 15 percent sodium chloride in a soothing base for the purpose of soothing skin.
United States Patent 3,867,522 (Kligman) discloses a composition for LLaai L of acne, which composition comprises sodium chloride crystals in 30 to 60 percent co~ LLcltion in a suitable vehicle or base which act6 as a carrier. The composition is applied to the affected skin in such a manner as to debride the lesions and comedos which are characteristic of acne.
United States Patent 4,608,044 (Nord~auist et al) teaches a ~ ess for LLt:a L of wounds, which ess is designed f or delivering salt to the wound .
Recently, a wound gel composition has been developed containing sodium chloride. See United States Patent 5,271,943 (Bogart et al). Therapeutic gels are disclosed comprised of water, sodium chloride, and a gelling agent.
This patent also presents a detailed t9i ~c~ n of the state of the art LLt:a; t of wounds with gel compositions and/or salt containing compositions, the entirety of which is inuuLp~Lclted herein by reference.
However, it has never, prior to the making of the present invention, been attempted to treat skin burns with a cu~ LL ated combination of salt and citrus juices .
The topical composition of the present invention is prepared by mixing 1 part lemon juice with about 2 to 2 . 5 wo s~n4829 21 8 5 5 83 PCTNS94/02787 parts salt. The salt may be any pharmaceutically acceptable, topin~lly tolerable salt, but most preferred f or reasons of cost and av~ hi 1; ty is common table salt ( sodium chloride ) . The salt may include minor amounts of sodium iodide and potassium chloride as found in common table salt . Other ingredients or modif iers may be added, so long as they do not substantialLy effect the therapeutic effect of the combination of salt and lemon juice. The product should be a pasty composition which can be easily applied to the skin and held in place by a gauze bandage.
The citrus juice may be obtained f rom any citrus fruit, such as lime juice, lemon juice, orange juice, pink grapefruit juice, regular grapefruit juice, sour orange juice, tangerine, tangelo, etc . but is pref erably lemon juice. The lemon juice is most preferably freshly squeezed lemon juice, but where such is not available, may be reconstituted lemon juice.
The composition ~ay be premixed and stored in the premixed state. The composition is storage stable in a refrigerator and maintains it's activity for months. As an alternative to premixing, it is possible to apply salt directly to a traumatized area of the 6kin and to squeeze a lemon over the salt so that the lemon juice wets the salt .
It has been found that the salt has little effect on the burn i nrl~r~.n~l.ontly of the citrus juices, but when - ~ in~rl with the citrus juices an ~ ecl healing WO 95/24829 2 1 8 5 ~ 8 3 PCTIUS94/~2787 effect occurs. It has not been confirmed whether the effect is due to the moistening, acidifying, or 6alinity, but the surprising healing effect has been dol ted.
D~r~n~9;n~ upon the intensity of the burn, the amount of composition to be applied may vary, but generally the composition is shaped and applied to a thickness of about 1/2 inch. The composition is held in place with gauze, and additional lemon juice is applied to the area of the gauze over the burn being treated so that the gauze is very moist. The composition of the present invention has it's greatest effect during the first part of the healing process, immediately after the injury. It is thus preferred to apply the composition to the injury as soon as possible after the trauma to the skin. The composition should be held in place for at leaGt 2 to 3 days for severe trauma, but after the first few days LLæ~ t with the composition may be discontinued and the healing proces6 allowed to continue with only conventional gauze hAn~lA~
An advantage of the composition of tne present invention is the feature that the composition is plastic and deformable, and thus can conform to the superficial contours of the wound.

1 ~s:
In each of the following examples a composition was prepared by mixing approximately 3/4 cup (6 ounces) of lemon juice or the e~uivalent thereof with 15 ounces of common table salt. There is no particular restriction on Wo 95/24829 2 1 8 ~ 5 8~ PCTIUS94101787 the manner of mixing, and common kitchen implements can be used. In each of the following examples the composition was applied to a thickness of about one half inch and wrapped with gauze, after which the gauze was wetted with lemon juice.
Example l - A female in her early 20's was severely burned over the entire palm of her hand when a match~ook ignited in her hand. The composition of the present invention was formed into a patch and applied within two hours, and kept in place for approximately one week. The patch was changed once every morning and once every evening. The pain was reduced immediately, the composition giving a cooling sensation. The palm healed completely, with no scarring.
Example 2 - While ironing clothes, an iron fell over onto the back of the hand of a small girl. The iron was immediately pulled away with concomitant removal of skin.
The composition was applied and kept in place until the skin surrounding the wound turned white. Thereafter the wound was ~Y~;ned, and a fresh patch of the composition of the invention was applied. After one week the LL~ai was discontinued, and after three weeks the wound had healed, and after one year no scar can be seen on the hand.
Example 3 - A ~h~n;c~l charge used to weld pipes was ignited and burned through a leather glove and into the back of the hand of an approximately 35 year old welder.
The wound was only the size of a penny, but formed a rather WO 95/24829 2 1 8 5 5 8~ S94J02787 deep third degree burn. The composition described above was applied to the back of the hand for a period of over 14 days, after which treatnent was discontinued. Pain was controlled, and the wound healed completely, leaving almost no scar.
Example 4 - While working on a truck, a watch worn on the wrist of 55 year old mechanic caused a short circuit between two truck batteries. The short circuit immediately heated the watch and severely burned the wrist of the mechanic. The composition of the invention was applied for 19 days, after which ~Ledi - t was discontinued. The wound healed leaving almost no scar.
A number of other burns were treated, including gasoline burns, grease burns, and stove burns, using the same composition described above. All healing ~JC~ ULLtd with minimum of pain and minimum or complete absence of scarring .
Although the topical composition of the present invention was first designed for treatment of thermal burns, and thus is particularly suited for such LLæa~ L~"
it will be readily apparent that the system is capable of application to related conditions of the skin, such as acid burns , radiation burns , etc ., and is thus capable of use in a number of other applications. Although this invention has been described in its preferred form with a certain degree of particularity with respect to treatment of thermal burns, it is understood that the present disclosure Wo 9~124829 . - 2 1 8 5 ~ ~ 3 PCTluS94/02787 of the preferred form has been made only by way of example and that uu~ changes in the details of ingredients of the composition and the manner of application to an injury may be resorted to without departing from the spirit ~nd scope of the invention.
Now that the invention has been described,

Claims (9)

What is claimed is:

1. A topical composition for treatment of trauma of the skin, comprising a mixture of citrus juice and salt.

2. A topical composition as in claim 1, wherein said salt is sodium chloride.

3. A topical composition as in claim 1, wherein said citrus juice is lemon juice.

4. A topical composition as in claim 3, wherein said lemon juice is freshly squeezed lemon juice.

5. A topical composition as in claim 1, wherein said trauma is skin burn.

6. A topical composition as in claim 1, wherein said salt is present in an amount of from 1.0 to 4.0 parts by weight per part of citrus juice.

7. A topical composition as in claim 1, wherein said salt is present in an amount of from 1.5 to 2.5 parts per part of citrus juice.

8. A topical composition as in claim 1, wherein said citrus juice is selected from the group consisting of lime juice, lemon juice, grapefruit juice, orange juice, tangerine juice, and tangelo juice.

9. A method for treatment of skin burn, comprising applying to said skin burn a composition consisting essentially of salt and lemon juice in proportions sufficient to form a pasty composition.