JP2010184941A - Sponge-based therapeutic composition for treating and preventing dermatosis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a therapeutic topical composition, having safe, effective and versatile action mechanism and achieving medication compliance of a patient. <P>SOLUTION: A therapeutic composition for treating skin conditions and dermatoses is provided. The treatable skin conditions and dermatoses include acne vulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, optical aging and actinic keratosis, and eczema; but are not limited thereto. The therapeutic compositions indicated herein are sponge species, more specifically, a freshwater sponge. One of the embodiment originates in Spongilla species, and is prescribed together with a pharmaceutically acceptable vehicle. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

(Field of Invention)
The present invention relates to a therapeutic composition suitable for the treatment of skin diseases. Specifically, the therapeutic composition of the present invention is derived from a eukaryotic sponge. The therapeutic composition of the present invention may be applied topically for the treatment of various skin disorders and skin diseases.

(Background of the Invention)
Skin diseases are a major medical and social problem worldwide. The most common and therefore most serious skin diseases include acne vulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photoaging and actinic keratosis It is done. Together, these skin diseases account for billions of dollars in medical treatment and unexplained emotional distress. The emotional effects of skin diseases are particularly relevant. This is because patients are easily sacrificed for vicious treatment physicians and treatment regimens whose effectiveness is questionable. Over the past 100 years, significant advances in pharmaceutical and dermatological procedures have greatly reduced the severity and frequency of skin diseases. However, many patients do not follow the often complex and tedious treatment protocols prescribed by their treating physicians. Furthermore, long-term use of antibiotics results in increased bacterial resistance of the bacteria responsible for various skin diseases. In addition, other chemotherapy may be extremely toxic and may have long-term toxic effects on the patient's health and skin. Therefore, there is an urgent need for alternative therapies to treat skin disorders that are safe, effective and easy to use.

  Acne vulgaris is the most common of all skin disorders and affects 85% of teenagers. About 80% of the population experiences acne at some point in their lives. In addition to being a serious medical situation, acne imposes a heavy emotional and psychological burden on its victims. Marion Sulzberger, MD, one of the founders of modern dermatology, said in 1948, “It is more traumatic than acne vulgaris, less maladapted between parents and children, and more common. There is no single disease that causes general instability and inferiority and general sums of distress. " The effect is significant and can lead to depression and suicide thinking. A survey of 1,985 people by the ASG revealed that 3 out of 4 people with acne feel depressed and almost half feel anxious. A study by William Cunlife, MD in the UK has shown that acne patients have a higher unemployment rate than age-matched controls and gender-matched controls. The study showed that over one-third of patients felt that if they were not acne they would have had a better job.

  Acne is a chronic disease involving the vesicles of the follicular sebaceous glands. Sebaceous glands are most abundant on the face and scalp, but are present on all parts of the skin except the palms and soles of the hands. Skin disorders caused by sebaceous glands are truly disorders of the entire hair follicular gland unit. The sites most commonly involved in acne are the face, upper chest, and back. Other less common areas include the upper arm, buttocks and upper thighs.

  Acne vulgaris develops its follicular sebaceous unit through a multifactorial pathogen. The main pathogenic factors in acne include excessive sebum production following androgen stimulation, keratinocyte (basal cells of the epidermis) overproduction, disruption of hair follicular sebaceous vesicle release, Propionibacterium acnes proliferation and chemotaxis Inflammation following action and release of various pro-inflammatory mediators.

  During puberty, increased adrenal androgen causes hypertrophy of the follicular sebaceous glands. These enlarged hair sebaceous glands produce increased amounts of sebum, which flows through the vesicular ducts of the hair sebaceous glands. The tube is lined with a keratinized epithelium. In acne patients, the production of vesicular keratinocytes lining the vesicles is increased and these keratinocytes are retained within the vesicles. The abnormally exfoliating keratinocytes and excess amounts of sebum accumulate in the vesicles and form a tiny swollen mass. This sebum-rich environment is Ideal for acnes growth. P. acnes are anaerobic bacteria that produce chemotactic factors and recruit proinflammatory molecules that are involved in the inflammatory phase of acne. Occlusion of pilosebaceous vesicles, the first pathologic event in acne, produces a micro-comedo that is a precursor of all acne lesions. It is the small swollen mass that results from the combination of hyperproliferative keratinocytes and sebum that results in vesicular embolism.

  Once the vesicle is occluded, its lower part fills with hair follicular gland discharge and keratinocytes and expands. While the opening of the hole remains closed, the lesion is called a closed comedo or “white face”. This is a non-inflammatory lesion that arises from a microfacet and appears to be slightly raised, with white spots ranging in diameter from 0.1 mm to 3.0 mm.

  Oxidation occurs when the vesicles are enlarged enough to widen the pores and the enclosed material is exposed to air. This causes the characteristic dark appearance of open comedones or “black faced”. An open face is a non-inflammatory lesion that is flat or slightly raised, brown to black, and appears to be about 3 mm to 5 mm in diameter.

  Early acne, including the majority of open and closed areas, is a non-inflammatory process. As the vesicle continues to expand, the epithelium of the vesicle is destroyed and irritants (eg, sebum, hair, and keratinocytes) are released into the surrounding dermis. This leakage causes an inflammatory response and begins to form inflammatory lesions, papules, pustules and nodules. P. acnes is a living bacterium that survives in the vesicle, but when the structure of the vesicle is destroyed, P. acnes acnes dies. Toxins are released into the dermis, which intensifies inflammation. Thus, uncomplicated inflammatory acne is a sterile process and not a skin infection. As the inflammation continues to worsen, larger papules and pustules are formed. Papules are pink to red raised palpable lesions with no visible accumulation of fluid, which can range from 1 mm to 4 mm in diameter.

  Pustules are raised accumulations of purulent material on the skin surface that are similar in size to papules. Pustules are often characterized as superficial or deep. In superficial pustules there is a localized rupture of the epithelium near the skin surface, and in deep pustules there is extensive destruction of the entire epithelium. Acne nodules are solid raised inflammatory lesions that are more than 6-10 mm in diameter and located deeper in the dermis. The bar can last for several weeks. Acne cysts are large nodules (which may be several centimeters in diameter) that become suppurated and softened. Scars are formed as a result of damage to the surrounding dermis. Scars can appear as small, deep-holed indentations (“ice picks”), atrophic plaques, hypertrophic papules, or extensively gradient indentations. Dark pigmented skin affected by acne tends to develop severe hyperpigmentation after inflammation. This trend leads to the suggestion that a new acne lesion-acne hyperpigmented macule (AHM)-should be designated. This AHM can last for more than 4 months and can often be a central complaint in patients with acne with colored skin.

  Although there is no single standardized classification system for acne, there are several useful methods used to classify this disease. Most simply, acne is described as mild, moderate, or severe. Since acne is a chronic, emotionally stressed state that can last for years, long-term treatment is often required. Currently, clinicians have a number of treatment options. However, each option has significantly detrimental properties and varies in effectiveness.

  The most commonly used topical product that does not require a prescription is benzoyl peroxide. Benzoyl peroxide (BP) It is an effective antibacterial agent for killing acnes. This takes about two weeks to function and must be used continuously to keep acne out. This is because BP does not affect the formation of microfacets, sebum production, or the way the skin vesicle cells are detached, and the acne reverts when the patient stops using it. Benzoyl peroxide is the trade name for over 200 formulations (including gels, creams, lotions, detergents, and bar soaps) at various concentrations (mostly 2.5%, 5%, and 10%). It is commercially available under When used continuously, it often improves the condition for mild acne cases. The concentration should be selected according to skin type and tolerance. Side effects mainly consist of skin irritation, including skin burning, blistering, cruising, pruritus, severe erythema, skin rash, dryness and chemical imbalance. Benzoyl peroxide further reduces skin levels of superoxide dismutase, catalase and other skin antioxidants that are important in preventing and healing acne. Furthermore, by destroying the naturally occurring antioxidants in the skin, benzoyl peroxide promotes premature aging of the skin.

  A topical treatment that does not require another prescription is salicylic acid. Salicylic acid helps to correct abnormal cell detachment and is useful in the treatment of milder acne. Salicylic acid helps unclog pore defects and eliminates and prevents lesions. However, salicylic acid does not inhibit the production of sebum and does not have antibacterial properties. Patients must use salicylic acid regularly to prevent acne from returning. Salicylic acid is available in many acne products, including lotions, creams, detergents, gels, and pads.

  In many cases, over-the-counter medicine (OTC) preparations are not effective and must be used in combination with prescription drugs. Antibiotics are the most commonly prescribed type of anti-acne prescription. Antibiotics are P.I. It functions to inhibit the growth of acnes and may be applied topically or taken systemically. The most widely prescribed topical antibiotics are erythromycin and clindamycin. Topical antibiotics penetrate P.D. and penetrate deeper into P.D. The ability to remove acnes is limited, and alone does not inhibit the formation of comedones and must therefore be used in combination therapy.

  Systemic antibiotics circulate throughout the body and enter the sebaceous glands. Systemic antibiotics are used to treat severe acne, but generally have more side effects than topically applied medications. Systemic antibiotics do not deal with other pathogens and can take weeks or months to cure acne. Oral antibiotics are usually used in combination with other drugs that “exclude disorders” vesicles such as salicylic acid. However, systemic antibiotic therapy is incompatible with the pregnant and some can reduce the effectiveness of oral contraceptive pills and there is a risk of pregnancy during the procedure.

  The first line of oral antibiotics for the treatment of acne is tetracycline. Tetracycline cannot be taken with foods that contain divalent cations (eg, calcium and iron) and, due to its photosynthetic nature, causes patients to have severe sunburns or pruritic rashes. Make it easier to take. All tetracyclines are banned (risk of discoloration) in pregnant and children who have not yet formed permanent teeth. In addition, tetracycline antibiotics often cause irritation to the esophagus. Side effects of minocycline (a commonly prescribed systemic tetracycline) can include dizziness, blue-gray discoloration of the skin and teeth, and lupus-like syndrome.

  Erythromycin has long been considered the preferred second-line oral antibiotic for the treatment of acne. It has an excellent side effect profile (gastrointestinal upset is usually the most common problem) and can be approved for use even in pregnant women. However, antimicrobial resistance is a major problem associated with all antibiotics commonly used in the treatment of acne, and this is most pronounced with erythromycin. Antibiotic resistance The appearance of acnes is an increasing problem with both topical and oral antibiotics in the treatment of acne. Over the past 25 years, laboratory studies have shown P.A. to antibiotics (especially erythromycin). shows a rapidly increasing pattern of resistance to acnes (published studies show that the overall incidence of antibiotic resistance P. acnes has increased from 20% in 1978 to 62% in 1996 Showing). Bacterial resistance can negate the effectiveness of current acne treatment and limit the options available to cure the most common skin conditions diagnosed and treated by physicians. Antibiotic resistance in acne treatment is Acnes antibiotic resistant strains are a global problem as reported in the UK, Germany, France, Japan and USA.

  Vitamin A derivatives or “retinoids” are increasingly being used as topical treatments for moderate to severe acne. These topical retinoids include vitamin A acid (tretinoin), its analogs, and newer factors that bind to and activate retinoid receptors. Topical retinoid preparations help eliminate pore damage and normalize skin growth and shedding. However, topical retinoids can cause severe skin irritation and therefore titration is required early in the treatment to allow the patient to adjust. Furthermore, local retinoids and retinoid analogs pose a risk of malformation. For example, Tazarotene is a pregnancy category X drug and should not be used in pregnant women.

  Recently, the FDA approved an oral retinoid isotretinoin (Accutane). Actan is recommended for patients with severe scars and cystic acne. Actin is anti-inflammatory and reduces the size of the sebaceous glands, thus reducing the amount of sebum produced, resulting in long-term acne remission and reducing scarring. After 6 months of treatment with a combination of topical and oral therapy, if less than 50% improvement in the severity of acne is observed, if there is scarring, acne associated with serious mental distress If seen, or if acne that recurs quickly is seen during or shortly after conventional therapy, Actan treatment is indicated. However, actin has a number of adverse reactions, including hypercalcemia with hepatotoxicity, increased triglyceride levels, pancreatitis, and decreased bone weight. In addition, Actan is teratogenic. As a result, the FDA has ordered that women receiving Actan treatment must use two forms of contraception. In addition, recently Actan has been linked to depression and suicide. Parents are required to sign a consent form expressing their understanding of this possibility and should be warned to carefully monitor the emotional status of teens being treated with Actan.

  Anti-inflammatory medications called corticosteroids are injected directly by dermatologists into severely inflamed acne lesions, helping to heal existing lesions. However, they do not prevent the development of new acne and the injection site can remain permanently cured.

  Acne vulgaris is a chronic dermatological disorder that should be treated consistently. It is not uncommon for traditional topical treatments to first worsen acne due to the irritation, sensitization and toxicity of the chemotherapeutic agents. This initial response usually lasts 2-4 weeks. Since it takes about 28 days to regenerate the skin, the effect of the drug does not appear immediately. If any, the improvement becomes significant after 4-8 weeks of treatment. The greatest benefits of systemic drugs (eg, oral contraceptives) in acne do not occur before the third to fourth month.

  Many OTC preparations are toxic to skin enzymes, which automatically makes the preparation toxic to the entire skin. Intracellular and extracellular enzymes found in the skin are essential for healthy skin condition, correct pH and the ability of the skin to protect against pathogens. The consequences of enzyme dysfunction cannot be revealed after one or several applications, even if trace elements that mainly act on the enzyme function are inactivated, only by repeated treatments . This repeated treatment can be applied multiple times a day for years, for example in the case of benzoyl peroxide preparations for acne-prone skin.

  Non-compliance with anti-acne regimens is a major reason for treatment failure among patients with acne vulgaris. Motivating patients and adhering to treatment, especially during the maintenance period, continues to be a challenge. A recent randomized controlled trial of young adults with acne vulgaris evaluated the effects of various non-pharmacological treatments to increase the adherence to benzoyl peroxide. Adherence was measured by a combination of patient self-report and return of self-monitoring card. The overall indication compliance rate after 3 months was 48%. This study found that 52% of patients were non-compliant. They did not follow the instructions of their dermatologist exactly because of the complexity of the regimen.

  Both researchers and treating physicians agreed that the simpler the dosing regimen for acne patients, the more adherence to instructions. There is a need for an effective, well tolerated, and simple regimen to improve dose rates between this group of patients.

  Acne is one of the most common skin diseases and one of the greatest economic and sociological significance, but can benefit from improved treatment regimens and compositions Not only skin disorders. For example, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photoaging, actinic keratosis, and many other bacterial diseases, viral diseases, and fungal diseases, and Skin pigmentation disorders are also serious health and cosmetic problems that require improved treatment with simple regimens.

  The Holy Grail is to slow or reverse the aging process. Aging is a complex process that is largely genetically determined. However, free radical damage caused by reactive oxygen species significantly contributes to the aging process. One sign of aging associated with free radicals is the so-called “aging plaque”. Age spots are actually the accumulation of a specific pigment called lipofuscin, which is a brown waste that accumulates in the skin of highly damaged areas.

Protection against free radical-related oxidative damage includes activation of water-soluble reducing agents in the cytosol, activation of fat-soluble antioxidants present in cell membranes, and antioxidant enzymes, superoxide dismutase, catalase Activation of ascorbate peroxidase, glutathione peroxidase and glutathione reductase. Biogenic production of free radicals occurs mostly during the normal process of cellular metabolism. A byproduct of energy metabolism is the uncoupling of electrons in the transmission system, producing superoxide. This superoxide leads to the production of hydrogen peroxide and superreactive hydroxyl radicals through the activation of molecular oxygen. Such reactive oxygen species (ROS) are highly detrimental to DNA, proteins and membrane lipids and cause cellular dysfunction. In the normal state of aging, the decline in antioxidant function accumulates the accumulation of additional aging processes and this exacerbates the progression of age-related degenerative diseases. Thus, prevention or reduction of reactive oxidant formation in metabolic electron transfer presents a clear strategy for reducing cellular oxidative stress and aging rates.

  Free radical damage has also been implicated as being a causal or exacerbating factor in eczema. A recent university-sponsored study tested lipid peroxidation levels in erythrocytes, several parameters of the antioxidant system, and the activity of lysosomal enzymes in mixed-derived (exogenous / endogenous) eczema patients. The results of this study showed enhanced red blood cell lipid peroxidation and reduced antioxidant protection. This imbalance in lipid peroxidation / antioxidation system causes changes in the structure of biological membranes, especially lysosomal biological membranes. This follows the increased intracellular activity of lysosomes and the subsequent penetration of lysosomes into the blood circulation and enhances signs of skin inflammation. For this reason, combined treatment of eczema should include antioxidant therapy and pharmaceutical stabilization of the lysosomal membrane.

  The Department of Dermatology and Skin Aging and the Research Center for Cancer (Pacer Research Center) at the University of Pavia, Italy, studied the activities of 14 enzymes. These enzymes represent the major metabolic pathways in the epidermis of 63 normal human subjects ranging from 1 month to 90 years of age. Despite the different ages, no difference in activity was observed for any of the enzymes studied. The absence of age effects on enzyme activity in the human epidermis increases the severity of variations. This variant has been reported in pathological conditions such as psoriasis, chronically sun-damaged skin and tumors.

  Furthermore, the reduction of enzyme activity in chronically sun-exposed skin has a significant contribution to tumorigenesis. This is clearly evidenced by the fact that sites that are always exposed to sunlight (eg, face, back of hands) are 100 times higher than the skin of sites that are not exposed (eg, abdomen). This leads to treating chronic sunlight damage as a precancerous condition. Chronic exposure to ultraviolet (UV) radiation is a major cause of skin changes due to extrinsic aging or environmental exposure. Estimates show that almost half of human exposure to UV occurs by the age of 18. Photoaging causes a number of histological, physiological, biochemical and clinical changes.

  One sign of aging skin is a decrease in the ability to detach dead cells, which results in various unsightly skin conditions. The recourse for topical treatment of photoaged skin continues to be chemical peel. Chemical epidermal exfoliation is a procedure in which a topically applied wound drug creates a smooth, rejuvenated skin through an organized repair process. Even if controlled chemical wounding is induced, complications of chemical resurfacing (eg, permanent discoloration such as pigmented abnormal discoloration, infection or scarring) can occur.

  Accordingly, there remains a need for a therapeutic topical composition that has a safe, effective, multifaceted mechanism of action and leads to patient compliance.

(Summary of the Invention)
The present invention relates to a novel skin care therapeutic agent derived from the invertebrate species Phylum Porifera. Sponge animals are commonly referred to as sponges. Due to early bifurcation events in animal history, sponges were separated from other metazoans. Fossil sponges, beginning with the late Precambrian period, are the oldest of the known animals, with over 900 fossil types. About 5000 surviving sponge species are classified into the marine sponge, which is composed of three different groups (Hexactellinida (glass sponge), Demospongia, and Calcarea (calcareous sponge)). The

  The composition for therapeutic skin care of the present invention is useful for the treatment and prevention of a wide variety of skin conditions. This skin condition includes, but is not limited to acne vulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photoaging and actinic keratosis. Furthermore, the skin care therapeutic agent of the present invention is useful as a skin surface regenerating composition, as a treatment for oily skin, and as a deep peel exfoliation treatment. In an exemplary embodiment, the composition of the present invention is applied topically. This topical application may be applied monthly, weekly, daily, or multiple times per day, depending on the condition being treated and the extent of disease progression. Furthermore, the compositions of the present invention can be applied in combination with other local or systemic treatments.

  In one embodiment of the present invention, the skin care therapeutic agent is derived from the Demospongia net, the Ceractinomorpha subnet, and the Porifera Subphyllum Cellularia of the genus Spongillaidae.

  In one embodiment of the invention, the sponge is harvested from a seawater source. Such seawater sources include, but are not limited to, saltwater lakes, seas and inland seas.

  In another embodiment of the invention, the sponge is harvested from a freshwater source (eg, rivers, lakes, ponds and streams).

  In yet another embodiment, the freshwater source is located in Eurasia (particularly the Russian Federation).

  In another embodiment of the present invention, the topical skin care therapeutic is made from powdered Spongilla.

In yet another embodiment of the present invention, the topical skin care therapeutic is Spongilla.
lactris L. Spongilla. made from powdered freshwater sponge selected from the group consisting of fragilis Leidy and Ephydatia fluviatilis.

  In yet another embodiment of the invention, the powdered Spongilla is blended with other active and inactive ingredients. Ingredients include antibiotics, anti-inflammatory agents, preservatives (eg, but not limited to hydrogen peroxide and boric acid), anesthetics, coral powder, white seaweed powder, green seaweed. ) Powder, enzyme gel, jojoba oil, but are not limited to these. The Spongilla powder is present in an amount of about 0.1% to about 100% Spongilla powder.

  In another embodiment of the present invention, the inert component comprises water selected from the group consisting of water for injection, distilled water, deionized water, chamomile water and calendula water.

  In another embodiment of the invention, the inactive ingredients include pharmaceutically acceptable diluents, fragrances, colorants and softeners.

  In yet another embodiment of the invention, the therapeutic composition comprises 1 gram to 1.5 grams of substantially pure Spongilla powder, and at least one additional excipient. This additional excipient is 0.1 grams to 0.5 grams green algae powder, about 0.1 grams to 0.5 grams white algal powder, 0.1 grams to 5 grams 0.2 grams coral powder , 0.5 mL to 5 mL of 0.1% to 10% hydrogen peroxide, 0.5 mL to 5 mL of 0.1% to 10% boric acid, and 0.5 mL to 10 mL of water.

The present invention also provides the following items.
(Item 1)
A composition for treating a skin disease, the composition comprising a sponge-derived product produced according to Good Manufacturing Practice (GMP).
(Item 2)
Item 2. The composition according to Item 1, wherein the sponge animal is sponge.
(Item 3)
Item 2. The composition according to Item 1, wherein the skin disease is selected from the group consisting of acne vulgaris, rosacea, seborrheic dermatitis, atopic dermatitis, psoriasis, photoaging and actinic keratosis. .
(Item 4)
Item 3. The composition according to Item 2, wherein the sponge is a freshwater sponge.
(Item 5)
The freshwater sponge is Spongilla lacustris L. Spongilla. Item 5. The composition according to Item 4, selected from the group consisting of fragilis Leidy and Ephydatia fluviatilis.
(Item 6)
Item 6. The composition according to Item 5, wherein the freshwater sponge is Spongilla lacustris.
(Item 7)
7. A composition according to item 6, wherein the Spongilla lacustris is harvested from the Arstrakian region of the Russian Federation.
(Item 8)
The composition of item 1, further comprising a pharmaceutically acceptable excipient.
(Item 9)
The composition of item 1, further comprising packaging, labels and instructions for use approved by the US Food and Drug Administration (USFDA).
(Item 10)
A therapeutic composition for treating acne comprising 0.1% to 100% Spongilla powder.
(Item 11)
Item 11. A therapeutic composition for treating acne according to item 10, wherein the therapeutic composition comprises water, glycerin, gel, oil, wax, softener, detergent, fragrance, preservative, anesthesia. A therapeutic composition further comprising a pharmaceutically acceptable excipient selected from the group consisting of a drug, seaweed powder, coral powder, hydrogen peroxide, enzyme gel, jojoba oil and boric acid.
(Item 12)
Item 12. The therapeutic composition according to Item 11, wherein the water is selected from the group consisting of water for injection, washing water, distilled water, deionized water, chamomile water, and calendula water.
(Item 13)
A therapeutic composition comprising:
0.8 to 1.5 parts of substantially pure Spongilla powder;
0.1 part to 0.5 part green algae powder, 0.1 part to 0.5 part white algae powder, 0.1 part to 0.5 part coral powder, 0.1 part to 0.5 part Psyllium powder, 0.5-5 parts 0.1% -10% hydrogen peroxide, 0.5-5 parts 0.1% -10% boric acid, 0.5-5 parts enzyme gel At least one additional excipient selected from the group consisting of 0.5 parts to 10 parts jojoba oil, and 0.5 parts to 5 parts water;
A therapeutic composition comprising:
(Item 14)
14. The item 13, comprising 1.5 parts substantially pure Spongilla powder, 0.2 parts green algae powder, 1.0 milliliter of 3% hydrogen peroxide, and 4.0 milliliters of 5% boric acid. Therapeutic composition.
(Item 15)
14. A therapeutic composition according to item 13, comprising a skin regenerating composition comprising 0.8 parts substantially pure Spongilla powder, 0.2 parts psyllium powder and 2.5 parts enzyme gel.
(Item 16)
14. Treatment according to item 13, comprising 1.0 part substantially pure Spongilla powder, 0.3 part white algae powder, 0.2 part coral powder, and 5.0 ml 3% hydrogen peroxide. Composition.
(Item 17)
Therapeutic according to item 13, comprising 1.2 parts substantially pure Spongilla powder, 0.2 parts white algae powder, 0.1 parts green algae powder, 5.0 ml 3% hydrogen peroxide. Composition.
(Item 18)
1.2 parts substantially pure Spongilla powder, 0.2 parts white algae powder, 0.1 parts coral powder, 4.0 ml 3% hydrogen peroxide, and 2 parts 2% boric acid. 14. The therapeutic composition of item 13, comprising.
(Item 19)
14. The therapeutic composition of item 13, comprising 1.2 parts substantially pure Spongilla powder, 0.2 parts white algae powder, 5.0 milliliters of chamomile water or calendula water.
(Item 20)
14. A therapeutic composition according to item 13, comprising 1 part substantially pure Spongilla powder and 2 parts 3% hydrogen peroxide.
(Item 21)
14. The therapeutic composition of item 13, comprising 5 parts substantially pure Spongilla powder, 5 parts 3% hydrogen peroxide, and 5 parts 2% boric acid.
(Item 22)
Item 22. The therapeutic composition of any one of Items 10 to 21, further comprising a USFDA approved package, label, and instructions for use.
Other embodiments and features of the invention will become apparent in the course of the following description and examples.

FIG. 1 shows a specific geographical location from which one of the sponges of the present invention can be harvested. FIG. 2 shows the patient before undergoing treatment for acne according to the teachings of the present invention. FIG. 3 shows the patient of FIG. 2 after undergoing treatment for acne according to the teachings of the present invention.

(Detailed description of the invention)
Natural seafood is a relatively new and growing research area for new industrial chemicals, biologics and chemotherapy. Natural marine chemistry is at the heart of this research and is responsible for the isolation and identification of the vast new molecules produced by marine organisms. Many of these molecules have structural features that are unique to marine organisms and arise from the unique aquatic environment (high levels of halogens and nitrogen) in which their host organisms live. There is accumulated evidence that many natural products isolated from marine organisms can be derived from symbiotic microorganisms present in the marine organism.

  Biologically active metabolites are produced by an organism for a range of purposes. This purpose includes release from environmental stress, chemical signaling, and invasion between species. These natural processes can inform the study of functional biomolecules for specific applications. For example, new sunscreen products have been discovered from basic research on coral reef resistance to ultraviolet radiation.

Sponges are multicellular marine animals that belong to a large group of single animal species known as invertebrates. Sponge originates billions of years ago and is the oldest animal on the planet. Currently, about 5,000 kinds of sponges are known. Sponge is composed of soft tissue suspended in a matrix of jelly-like proteins supported by a rigid skeleton composed of needle-like structures known as bone fragments. The bone fragments are mainly composed of calcium carbonate or silica and collagen.
The sponge belongs to the sponge phylum, a highly primitive group with no organized histology. The cured body contains a number of channels and holes that allow the inflow of fresh water. The largest of the flow holes is known as the large hole, and the smallest is known as the small hole. Food-containing water flows into the sponge through small holes in the body of the mound-like body and out through the large holes. Water is caused to flow into the sponge by the action of flagellar collar cells. Collar cells also constitute a filter-feeding apparatus that traps suspended food particles as they pass through a series of internal channels. Since sponges are inherently sticky, sponges are highly dependent on the effectiveness of their cell-lined channels in food capture, oxygen uptake and removal of waste. Sponges are highly sensitive to contamination and release by suspended sediment, which sediments the delicate system of sponge tubes and pores, thereby impeding basic body functions. Sponge has a strong regenerative power from trauma or predation.
In sponges, two types of reproductive processes are known to occur: one is asexual reproduction and the other is true sexual reproduction. In typical freshwater sponges, the deeper layers of sponges are filled with very small materials for the fall. This is sometimes referred to as a “seed” or “blast”. When a complete sponge dies, the seeds enclosed in the case go through the winter without being damaged. In spring, a mass encased in a sac of sponge particles stimulated by changes in water temperature creeps out of the “seed” and grows into a sponge.

  The success rate of discovering new active chemicals in marine organisms is 500 times higher than that of terrestrial sources. Sponge has proven to be a source of many new therapeutic agents and often has a biomedical effect that is superior to existing pharmaceuticals. Drug discovery from sponge colonies is now a major focus of the pharmaceutical and biotechnology industries. However, the main areas of concern for this new source of therapeutic agents are problems with its supply and the difficulty of culturing sponges and their symbiotic cultures in the laboratory. The reliability and reproducibility of natural source derived materials is also important. This is because seasonal and environmental changes interfere with the chemical composition and biological properties of natural samples. Furthermore, biologically active molecules are expected to be produced only temporarily in response to certain environmental stresses. Extracting a sufficient amount of active chemicals from natural sources to complete a single clinical study requires many tons of sponge colonies. As a result, this is not a viable option because it is distributed worldwide. Thus, while marine biotechnology shows great potential for new medicines, it has little or no commercial success.

  Nevertheless, like many natural products, sponges have been used in homeopathy and other forms of natural medicine for centuries. Eastern Europe and Eurasia have a long history of preparing tinctures and powders from aquatic animals, including freshwater sponges. Collectively, the folk medicine known as “Bardiaga” refers to powdered freshwater sponge and is used in medical applications. Russian folklore and homeopathic teachings suggest that Bardiaga is useful in the treatment of various syndromes such as contusions, arthritis and rheumatism.

  Bath sponge (Spongia officinalis) has also been used for centuries for wound cleansing, for contraception and as a graft after breast cancer surgery. In addition, the folk medicine and natural medicine literature documents many different preparations made from dried sponges and used to treat and alleviate various diseases. The earliest medicinal sponge preparation in recorded history is the dried and blown S. officinalis. S. officinalis is provided as a treatment for goiter and thyroid-related diseases. S. The unusually high concentration of iodine produced in officinalis is a uniquely effective folk remedy.

  Since sponges are basically non-motile animals that are highly sensitive to predators and changes in the sponge's microenvironment, sponges are abundant biologically active (bioactive) compounds. Evolving an anabolic defense system that includes. Today, many of these sponge-derived bioactive compounds are believed to have cytotoxic, antibacterial, antiviral, anti-inflammatory, and anti-fouling properties. However, most of these bioactive compounds remain uncharacterized. Furthermore, as discussed above, these bioactive compounds are produced at very low concentrations on a weight percent basis, and therefore their isolation in pure form is literally the harvest and processing of several tons of sponges. Need. Many of these bioactive compounds derive their effectiveness from natural synergistic and complementary mechanisms. This mechanism is lost when studied in purified and isolated state. Thus, the inventors have invented a technology for developing sponge species compositions, formulations and applications. This technique eliminates the need to purify and characterize individual bioactive compounds, maintains the strength of its potential synergistic properties, and solves supply problems and environmental impacts.

  Freshwater sponges (including but not limited to Spongilla lacustris L., Spongilla fragilis Leidy, and Ephydatia fluviatilis) are currently intended to provide pharmaceutical compositions that have undergone rigorous safety and efficacy testing Is not used. The present inventors have discovered that sponges can be a natural source of complex biologics that provide new compositions useful for treating, alleviating and preventing various diseases. These various diseases include, but are not limited to acne vulgaris, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photoaging and actinic keratosis. The synergistic multidrug therapy of these complex biologics has the advantage of greater therapeutic effect and less overall toxicity than synthesized single component drugs. Specifically (not intended to be limiting, but merely as an exemplary embodiment of the invention), the inventors have identified the freshwater sponge species Spongilla lacustris L. Therapeutic compositions derived from have been developed.

  In one embodiment of the present invention, anti-acne vulgaris therapeutics are provided that effectively treat, alleviate, and in some cases prevent the most important pathological factors in the development of acne. These pathological factors include production of excessive amounts of sebum, excessive production of keratinocytes, blockage of vesicular sebaceous vesicle outlets, p. acnes growth and inflammation. Furthermore, the anti-acne preparations of the present invention are useful in therapeutic regimens and are non-toxic when used as directed. The topical anti-acne preparations of the present invention can be used alone or in combination with other local or systemic therapeutic agents.

  As discussed above, acne vulgaris is a common multipathogenic inflammatory disease of the follicular sebaceous duct. Propionibacterium acnes grown in sebum produces chemotactic factors that are subsequently phagocytosed. This process produces reactive oxygen species that contribute to the inflammatory response in papulopustular acne. The overuse of antibiotics is An antibiotic resistant strain of acnes appears. This makes its treatment and prevention difficult. About 60% P.I. acnes is resistant to one or more antibiotics typically used to treat acne. Benzyl peroxide can be used as an alternative treatment in sterilizes acnes but promotes aging before skin maturation. In addition, benzyl peroxide reduces the already reduced skin levels of superoxide dismutase, catalase and other skin antioxidants that are important for the prevention and healing of acne. As a result, interest in bacterial resistance to currently available anti-acne antibiotics, the harmful effects of topically applied compounds such as benzyl peroxide, and the serious side effects of oral drugs such as retinoids Has created a great need for new, safe and effective treatments for acne vulgaris in addition to other skin diseases.

  The mechanism of action relating to the novel anti-acne therapeutic agent of the present invention is multi-faceted. As with most complex biotherapeutic agents such as low molecular weight heparin preparations (eg, enoxaparin sodium), the exact mechanism of action of the composition is not fully understood. However, although we are not bound by these theories, the active ingredients of the anti-acne preparations disclosed herein act synergistically through one or more of the following mechanisms: I think so. The present invention stimulates a localized histamine response that dilates blood vessels, thereby increasing blood flow to the treatment area. This results in an increase in the amount of oxygen, nutrients, and antibodies that reach the skin cells. Due to stimulation of blood circulation and lymphatic drainage, removal of excess fluid, bacteria, and debris is increased. Furthermore, the topical therapeutic agent of the present invention dissolves excess sebum, reduces sebum production, and reduces the stickiness of the excreted sebum. This prevents the clogging of the holes and the resulting formation of face pockets. In addition, fine organic residues (such as, but not limited to, bone fragments of the skeleton that mechanically separate the epithelial surface) reduce keratinocyte adhesion, thereby reducing the stratum corneum. Molting and removal of sebum plugs and loose keratinocytes is improved. This opens the pores and prevents future occlusion and the resulting formation of ridges. Naturally occurring antibiotic compounds kill bacteria that cause acne. Natural steroids reduce inflammation. Similarly, it can also act as a vasodilator and improve local microcirculation. Continued use of the topical therapeutics of the present invention can reduce skin fatty acid levels and normalize keratin turnover in the follicular sebaceous vesicles. Furthermore, significant clinical evidence supports the conclusion that the therapeutic preparations of the present invention also produce direct and indirect anti-inflammatory effects.

  Prolonged infection with multiple acne changes the chemical balance of the skin and ultimately the body's chemical balance. For example, people with moderate to severe acne have significantly less zinc in their bodies than those who do not have acne of the same age. In addition, those with chronic acne have skin that is uniquely deficient in linoleic acid and protective antioxidants.

  The present invention corrects the above imbalance and allows the skin's immune process to effectively control bacteria and prevent infection. Thus, in one embodiment of the present invention, the composition is prepared to have a high biological activity, high concentrations of zinc, linoleic acid acting to block conditions that lead to acne and promote its healing, Contains antioxidants, calcium and other biochemicals.

  When used as a skinning agent, the present invention regenerates the skin, stimulates new cell growth, elastin and collagen production, and improves skin tension and texture. The enzyme contained in this composition lyses and digests old, debilitated or dead cells from the outer layer of the skin without harming young living cells, resulting in a softer, smoother skin. Overall, the composition dissolves and infiltrates stagnant spots, removes superficial scarring, regulates skin pH and sebum production, and further acne eruption and scar formation To help prevent.

  The inventors have found that the compositions disclosed herein are mild, moderate and severe acne, rosacea, seborrheic dermatitis, eczema (atopic dermatitis), photoaging and light. It was shown to be effective in the treatment of keratosis. Furthermore, the compositions of the present invention can be used safely with traditional therapeutics for acne and other dermatological diseases. These treatments include traditional antibacterial handwashes, astringents, salicylic acid preparations, and systemic treatments (including but not limited to antibiotics and anti-inflammatory prescription drugs). It is not limited.

Both the over-the-counter pharmaceutical preparations and prescription pharmaceutical preparations of the present invention are considered within the scope of the present invention. Furthermore, the compositions of the present invention are currently undergoing clinical trials and are intended to be used in professional environments that are administered and used under the direction of a qualified physician. Such compositions of the present invention may also include instructions for use and product labels approved by the US Food and Drug Administration (USFDA) and other health care agencies around the world. In one embodiment of the product of the invention, 21 U.D. S. C. Chapter 9, Subchapter V, part A section 352 and section
Product labels and instructions for use in accordance with all applicable chapters of 21 CFR part 201 and beyond (referred to as FDA approved product labels and / or package inserts) are provided.

  Compositions made in accordance with the teachings of the present invention have been extensively analyzed. The dried and granulated raw material of the present invention is an odorless, gray red non-hygroscopic powder. This powder is partially water soluble and forms a greenish red solution when mixed in a ratio of 1: 3; about 50-60% remains insoluble and the composition of the present invention Contains organic fractions that give mechanical wear to objects. The pH of the solution fraction is between about 7.0 and 7.5 and the average pH is 7.35. The specific gravity of the solution fraction is between about 1.04 and 1.07, and the average specific gravity is 1.058. Absorbance peaks are observed between 210 nm and 250 nm when measured between 200 nm and 900 nm using methods known to those skilled in physical chemistry.

  Table 1 includes non-limiting representative analyzes of organic and inorganic components.

^＊範囲はおおよそであり、使用されるアッセイ法についての普通の実験上の標準偏差に基づく。アッセイは、分析化学の分野の当業者に公知な標準的な分析手順を使用して行われた。酵素活性は、乾燥物質１００ｍｇ当たりの酵素活性ユニットで示される。ユニットは、各アッセイに対して認められた国際生物学的標準（Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｂｉｏｌｏｇｉｃａｌ Ｓｔａｎｄａｒｄ）に基づく。

^* Range is approximate and is based on common experimental standard deviations for the assay used. The assay was performed using standard analytical procedures known to those skilled in the field of analytical chemistry. Enzyme activity is expressed in enzyme activity units per 100 mg of dry matter. Units are based on recognized international biological standards for each assay.

  One skilled in the art understands that elemental and organic analyzes performed on representative samples are not intended to enumerate, even partially, the active ingredients found in the compositions of the present invention. It should be. As already discussed, there may be various bioactive molecules that have not been previously identified in the sponge products of the present invention. The analytical data in Table 1 provides one of ordinary skill in the art with non-limiting data that may be useful in characterizing compositions made in accordance with the teachings of the present invention. However, in addition to other possible synergistic and complementary bioactive compounds included in the present invention, the components identified in Table 1 may also provide certain beneficial effects. While not wishing to be bound by this theory, we propose a possible role for many of the components quantified in Table 1.

  The Medical Research Council at Dunn Clinical Nutrition Center, Cambridge, UK, is a P. cerevisiae isolated from human faces. A study showing the reduction of catabolic nitrate by acnes was conducted. Low concentrations of nitrite (approximately 0.2 mM) are Acnes growth was inhibited. This nitrite is slowly reduced to nitrous oxide, allowing growth to occur. This suggests a denitrification function as a detoxification mechanism.

  Copper is involved in collagen production. Collagen is a protein responsible for the structural strength of bone, cartilage, skin, and tendons. Copper is also involved in the production of elastin. Elastin is primarily responsible for the elastic properties of blood vessels and skin. Research has shown that copper is also essential for the organization building process. As we age, our skin becomes thinner and wrinkles and wrinkles develop, our bodies also produce collagen, elastin and glycosaminoglycans (GAGs) more slowly. GAGs function as a binder that binds tissue components together. As cell regeneration slows and the skin retains less moisture, age spots appear and the copper loses its luster and vitality. Scientific research has shown that it plays an important role in skin health by helping to restore the self-renewal ability of the skin. Copper is a strong promoter of collagen and elastin and performs an antioxidant function in the body. This is important in the production of GAG. Copper-dependent enzymes increase the benefits of the original tissue building process.

  Zinc destroys the dysfunctional tissue of acne through a group of enzymes called metalloproteinases, thereby allowing the site of infection to be reconstructed. Zinc directs the body's T cells to bacteria and infection by a signaling chemical called adenosine deaminase. Zinc is an important element in the production of new skin cells, new collagen and elastin, new blood vessels and other skin components. Moderate to severe acne consumes the body's supply of zinc according to the literature, rendering the patient systemic zinc deficient. If the skin is zinc deficient, cleanup and repair of the infection can be slow and possibly incomplete. This creates the possibility of scarring. Zinc is particularly important in cystic acne. This is because cystic infections do not discharge waste material.

  A sufficient amount and the correct form of zinc also acts to prevent acne as well. Testosterone in the skin is converted to dihydrotestosterone. Dihydrotestosterone stimulates sebum production and promotes acne. Zinc blocks this conversion through 5α-reductase inhibition, thereby reducing sebum production. Zinc is required for the production of skin super-antioxidants that reduce damage from free radicals and continues to advance the healing process by reducing inflammation.

  Glucocorticoids are widely used for the treatment of various diseases, despite known side effects such as skin atrophy. Many studies have shown that the state of collagen fibers in the skin is affected by glucocorticoid treatment. The results of studies in Japan have shown that treatment of skin with glucocorticoids strongly interferes with both type I collagen synthesis and degradation and more intensely type III collagen synthesis and degradation. Type III collagen is a molecule known to play a major role in the initiation of wound healing. This study provided a molecular basis for the deterioration of skin function, impaired wound healing, and skin atrophy caused by glucocorticoid treatment. In contrast to experiments with synthetic steroids, the naturally occurring steroids included in the present invention provide excellent anti-inflammatory effects without the detrimental properties described above.

  Enzymes are specific biological catalysts in the skin. A single enzyme production deficiency or impaired activity leads to metabolic disorders and worsening of acne conditions. Since the activity of many enzymes is significantly suppressed in skin with metabolic disorders, photoaging, and cancer, the presence of the enzyme in a therapeutic agent is most desirable for the treatment of the above diseases.

  Alkaline phosphatase (AAP) is a single enzyme of the “bone-liver-kidney” type and exists in the skin in both soluble and membrane-bound forms. It is almost exclusively present in the dermis, with less than 1% of total alkaline phosphatase in human skin present in the epithelium.

  In studies conducted on leukocyte enzyme activity from cuts of skin, cytochemical analysis showed that enzyme activity increased rapidly by 4 hours after the wound occurred. This can be explained by changes in leukocyte metabolism induced by the pathogenesis of injury. Thus, it suggests an important role for AAP in wound healing.

  Asparaginase is an enzyme that has proven particularly promising for the treatment of cancer. Its action depends on the fact that tumor cells are deficient in aspartate-ammonia lipase activity. This deficiency limits the ability of tumor cells to synthesize L-asparagine, a normally nonessential amino acid. This forces the tumor cell to extract its L-asparagine from the body fluid. This action of asparaginase does not affect the functioning of normal cells that can synthesize enough of their needs, but in sensitive tumor cells it reduces the free foreign concentration and hence Induces a deadly starvation. A complete remission with a frequency of 60% has been reported in a study of about 6,000 cases of acute lymphoblastic leukemia.

  γ-Glutamyltranspeptidase (GGT) is another enzyme important in antioxidant defense and anticancer defense. GGT activity was seen in both epithelium and dermis, with the former being more active. GGT is one of the most studied chemicals in cancer chemoprevention, a desirable and important aspect of biomedical research.

  Superoxide dismutase (SOD) is the best known and perhaps the most important antioxidant enzyme. This converts superoxide, a very harmful free radical, to a less active peroxide. This peroxide is then further converted into water by another antioxidant enzyme, catalase (CAT). The natural synergistic interaction between these two antioxidant enzymes constitutes the most efficient system of free radical control in our body. The combined activity represents a major anti-aging factor. A deficiency in SOD / CAT is the most causative factor in most inflammatory processes.

  Research suggests that SOD may be the most important enzyme for removal of free radicals and maintenance of cell membrane integrity. Compositions comprising SOD / CAT have shown utility as pre-operative and post-operative supplements. When administered to surgical patients, a significant improvement in recovery rate and a decrease in recovery period have been observed. Furthermore, when used as a therapeutic agent, SOD can exert a strong regenerative effect in tissues that are hardened or fibrotic due to aging, disease or injury.

Suleyman Demirel University of Isparta, Turkey
In a study conducted at the Department of Medicine's Department Dermatology, researchers investigated the role of reactive oxygen species in the inflammation of acne by determining the activity of antioxidant defense enzymes in lymphocytes. This result indicated that the activity of SOD was significantly reduced in the acne group. Researchers have suggested that drugs with antioxidant effects are valuable in the treatment of acne patients. This is because the antioxidant defense enzymes of acne patients are significantly impaired.

  Ceruloplasmin (CP) is a copper-containing protein that is an important extracellular antioxidant and free radical scavenger. The liver is the first organ that expresses CP; however, recent studies have identified that the lung is another major site of CP synthesis. Ceruloplasmin plays an important role in host defense against oxidative damage and infection.

  In an exemplary embodiment of the invention, the sponge used to prepare the topical therapeutic agent is Spongilla lacustris. As briefly discussed above, crude preparations of freshwater sponge colonies of various genera (including but not limited to Spongilla lacustris L., Spongilla fragilis Leidy and Ephydatia fluviatilis) Have been used for centuries to prepare folk remedies (eg Bardiaga). However, these crude preparations generally are indeterminate of various sponge genera, various contaminants including other marine species, soil sediments, and other debris associated with the natural habitat of the sponge. Contains a mixture. It is manufactured without the batch-to-batch consistency required for pharmaceutical products. In addition, sponge colonies are randomly collected regardless of environmental conditions (for example, but not limited to, the presence or absence of predators, water temperature and pressure, oxygen availability, salinity, season and life cycle). It was. As a result, these compositions, like many other crude natural products, are almost ineffective and often dangerous to use. Unlike crude folk remedies, the therapeutic composition of the present invention comprises a substantially pure Spongilla powder. As used herein, “substantially pure” means separated from environmental debris (including rocks, sticks, other marine organisms, etc.), washed, dried, ground , Sieved, and sized natural products (especially Porifera sp.).

  The inventors have determined through analysis and clinical studies that collection conditions and prescribing protocols are important in providing reproducible and effective local therapeutic agents. Freshwater sponges are readily identified by a properly trained marine biologist with skills below the skilled person. For example, Spongilla appears as a dull creamy brown to medium brown amorphous body when a freshwater aquatic environment is observed. Often, larger sponge colonies appear greenish due to algae trapped within the sponge body. Furthermore, evidence of sponge viability and bioactive compound excretion can be observed empirically, including factors such as algae not overgrowing and low predation rates.

  Spongilla lacustris is generally preferred for making the compositions of the present invention. This is because this sponge genus is highly resistant to natural environmental changes and grows very well in a wide range of habitats. In order to avoid collecting environmentally induced variants with lower than ideal potency, we preferably do S. cerevisiae on a warm sunny day at the end of summer. It was decided to collect lacustris. If sudden environmental changes occur that adversely affect sponge viability, collection should be terminated.

  S. Convenient aquatic environments for the production of lacustris include identifiable substrates with submerged rocks, bars and branches. In general, because there is no strong current, lakes are better natural habitats than rivers and streams for the generation of large sponge colonies. In still waters such as lakes, freshwater sponges form finger-and bush-like form colonies in the shape of deer horns, ranging from 2.4 cm to 40 cm across. . Water transparency is also an important environmental factor that supports large, developed Spongilla lacustris colonies. Water made opaque by sand, mud and dissolved solids inhibits sponge growth, thereby reducing colony size and sponge quality. As a result, lakes with muddy water, opaque water, and turbulent water, as well as contaminated source water should be avoided when choosing a collection site. In one embodiment of the present invention, lacustris is collected from a freshwater lake in the Russian Federation (specifically, the Astrakhan region) northwest of the Caspian Sea, as shown at 101 in FIG.

Once a suitable aquatic environment and sponge habitat is identified, sponge collection can be initiated using methods generally known to those skilled in marine biology. For example, sponges can be collected manually using basic underwater diving techniques, or in deep water, larger colonies can be collected from Agassiz trawl (AGT) or near-bottomed organisms. thread) (EBS). However, sponges smaller than 0.5 cm in diameter are unlikely to be collected by AGT. Under certain environmental conditions, S. Lacustris colonies arise on thin crust-like carpets that are several meters across and must be collected manually using fork-like instruments and nets.

  Freshly collected sponges collected from aquatic habitats are mucous amorphous masses that give off a characteristic odor that most observers describe as unpleasant. Before the collected sponge mass is dried, the visible contaminants must be washed. This contaminant includes part of the substrate, part of the shell, part of the stem, part of the plant, part of the small freshwater animal, part of the rock and part of other impurities. The sponge mass is then washed to remove soil, sand, silt, and soluble impurities. The wash water is changed repeatedly until it becomes clear and the sponge appears free of contaminants. After removing and washing the debris visible to the naked eye, the sponge mass is weighed and dried. Drying is preferably done in the open air on a warm sunny day. However, commercial scale dryers used to dehydrate foods and pharmaceuticals can also be used appropriately. In general, sponge collection occurs in remote countryside due to difficulties in developing and maintaining artificial “sponge farm” habitats. As a result, large commercial scale drying facilities are rarely available. Instead, the collected sponge colonies can be sent to a cold storage facility repository for sponge quarantine, subsequent processing and further investigation.

  When dried under ambient field conditions, temperature, dew point, relative humidity, and precipitation predictions must be closely monitored. If the ambient temperature is too low, or if precipitation is expected, the sponge mass should be dried in a room where temperature and humidity can be controlled. Although it is not essential that a detailed temperature range or humidity range be maintained, the sponge mass must be maintained within a temperature range and humidity range suitable for the evaporation process to proceed uninterrupted. For example, the temperature must be higher than 60 ° F. and the relative humidity must be less than 90%. However, it is recommended that the sponge mass should be protected from exposure to atmospheric precipitation and excessive temperatures after collection. The sponge mass is dried until the remaining water content is less than 10%, preferably less than 5%. If the raw material is stored for a long time before further processing, the remaining moisture can be as low as 0.1% or less. The measurement of the remaining moisture can be performed using methods generally known in the fields of food science, analytical chemistry, or pharmaceutical science. For example, 10 grams of dry substance is placed on a tare weighing boat and then weighed. A heat source such as a drying oven or heating lamp that is operated at a temperature sufficient to evaporate the weighed material and then any remaining free moisture or loosely bound (not chemically bound) moisture Expose to. The sample is then cooled in a drying chamber and reweighed. The remaining moisture is calculated as the percent difference between the sample weight before drying and its weight after cooling.

  Once dried, the sponge is packaged in a sealed container, protected from light, and maintained at 55 ° F. to 75 ° F. during quarantine. Good Manufacturing Practices Requirements (GMP) and International Standards are applicable to food, drugs and cosmetics before a given quality control process is released from quarantine and further processed Organized) (ISO) is performed on the dry sponge material. Tests include microbiological cultures against pathogenicity, E. coli type organisms, and bioburden. Chemical analysis is also performed to verify the identity, effectiveness and purity of the product. All processing after the initial drying period must be done in an environmentally controlled facility that complies with GMP and ISO guidelines. Manufacturing personnel must be trained in GMP and ISO procedures, and all manufacturing processes must be closely monitored and recorded.

  After being released from quarantine, the raw dry material, sponge, is further refined and processed to a standard particle size using a sieve. This dry sponge is very fragile and requires only light and gentle grinding to form uniform fine particles. Dried sponges collected and processed in accordance with the teachings of the present invention must not be processed using vigorous crushing techniques; rather, this dried sponge is used to avoid crushing debris that may be present in the sample. Processed gently. For example, shells from aquatic mollusks can be present in the crude sample; the grinding of the crude sponge preparation is performed in a manner that does not pulverize the contaminated shells to such an extent that they are not removed in the sieving process. Should be. Several grinding and sieving steps are performed to reduce the average particle size to 0.2 mm or less. In the first pass, the grinding and sieving process is also used to reduce the particle size to at least 2 mm. This initial sieving process allows visual inspection and removal of residual non-sponge debris, followed by a grinding and sieving process, where the feedstock is ultimately reduced to particles below 0.2 mm .

  The sized material is then ground again and sieved to reduce the particle size to 0.2 mm or less. After the dried sponge powder is crushed, it is further purified and separated from contaminants by treating the powder with a sieve having progressively smaller gaps (1 mm, 0.5 mm, and 0.2 mm, respectively). The All processes are performed under GMP conditions.

  After the final grinding and sizing process is complete, the dry sponge material is packaged in an airtight moisture-proof container and stored at 55 ° F. to 75 ° F. in the dark under dry conditions. Since Spongilla powder is naturally antimicrobial, no preservative is required. Spongilla powder collected, processed and stored in accordance with the teachings of the present invention is stable for a minimum of 3 years and 6 months (stability data available at the time of filing this patent). However, accelerated test data can suggest a much longer stable period (up to 10 years).

  The therapeutic compositions of the present invention comprise from about 0.1% to 100% substantially pure Spongilla powder and can be formulated with pharmaceutical excipients as needed. These excipients include water, saline, buffered phosphates, oils, gels, waxes, softeners, glycerin, detergents, fragrances, colorants, preservatives, and anesthetics. It is not limited. Suitable waters include in particular water for injection, wash water, distilled water, deionized water and in particular floral water. Even clean tap water is acceptable for some applications. The concentration of the aforementioned excipients can vary from 0.001% to 50% or more, depending on the requirements and reasoning of the prescribing scientist, pharmacist, or prescriber. Such ranges are well known in the art and can be determined without undue experimentation. Other excipients that may be used in accordance with the teachings of the present invention include about 0.1% to 25% coral powder, about 0.1% to 25% seaweed powder, about 0.1% to 10% excess. There may be mentioned hydrogen oxide and about 0.1% to 10% inorganic or organic acid, including but not limited to boric acid, hydrochloric acid, ascorbic acid, salicylic acid and the like.

  The therapeutic compositions of the present invention generally comprise 0.8 grams to 1.5 grams of substantially pure Spongilla powder, and at least one additional excipient. This excipient comprises 0.1 to 0.5 grams of green algae powder, 0.1 to 0.5 grams of white algae powder, 0.1 to 0.5 grams of coral powder, 0.1 to 0.5 Gram psyllium powder, 0.5 mL to 5 mL 0.1% to 10% hydrogen peroxide, 0.5 mL to 5 mL 0.1% to 10% boric acid and 0.5 to 5 mL water, 0.5 mL ~ 5 mL enzyme gel (water, hydroxyethylcellulose, hyaluronic acid, propylene glycol, methylparaben, EDTA tetrasodium salt and propylparaben in proportions suitable for topical application known to those skilled in the art), 0.5 mL to 10 mL jojoba oil Selected from the group consisting of Other excipients such as, but not limited to, saline, buffered phosphates, oils, waxes, softeners, glycerin, detergents, fragrances, colorants, preservatives and anesthetics are It can be added as desired or needed.

  The following examples provide formulations using exact amounts in grams and milliliters of each component. However, these exact weights and volumes should not be considered limiting. All liquids used herein are aqueous based and contain a low percentage of solute. Therefore, the relative weight of each volume of liquid component is considered equal to the weight of water (1 g / mL). For this reason, the appended claims are expressed as a ratio. For example, a composition made in accordance with the teachings of the present invention comprises 1.5 g of substantially pure Spongilla powder, 0.5 mL hydrogen peroxide, 2 mL 5% boric acid, 1 gram green algae powder and 10 mL floral. May contain water. The composition is then claimed as follows: 1.5 parts substantially pure Spongilla powder, 0.5 parts 3% hydrogen peroxide, 2 parts 5% boric acid, 1 part Green algae powder and 10 parts floral water;

Example 1
(Basic local acne treatment)
Therapeutic compositions prepared from dry Spongilla powder can be prepared using formulation excipients and procedures known to those skilled in the art of topical pharmaceutical preparations. For example, in one embodiment of the present invention, the topical acne treatment consists of 1.0 grams of Spongilla powder (active ingredient) and 2.0 milliliters of 3% hydrogen peroxide (vehicle). Combine the ingredients and mix together. The mixture is then heated in the microwave for about 7 seconds. During heating, the hydrogen peroxide is converted to water and oxygen, thereby producing a homogeneous and uniform fluffy mask. The therapeutic agent is then applied to the entire face while massaging with a circular motion, left for 15 to 30 minutes, and then washed off with water. Recommended usage is every 5-7 days.

(Example 2)
(Topical acne treatment for professional use)
In another embodiment of the invention, the topical acne treatment consists of 1.5 grams of Spongilla powder, 1.0 milliliters of 3% hydrogen peroxide, and 3.0 milliliters of 5% boric acid. Mixing and applying this topical anti-acne composition for professional use involves mixing the powder with a warm liquid just prior to use. This therapeutic agent is then applied to the face or other affected areas by circular motion, left for 25-30 minutes, and then washed off with water. Recommended usage is every 4-5 days.

(Example 3)
(Topical acne composition for home use)
In one embodiment of the invention, a topical acne treatment for home use comprises 0.8 grams of Spongilla powder, 0.2 grams of psyllium powder and 2.5 milliliters of enzyme gel. Mixing and applying this topical anti-acne composition for home use involves mixing the powder with a liquid just prior to use. The contents are then applied to the face or other affected area using a brush, left to dry for 15 minutes, and then washed off with water. Recommended usage is daily for a week or until the face is clean, and then once a week for maintenance.

Example 4
(Professional skin surface regeneration composition)
A suitable formulation for professional skin surface regeneration consists of 1.5 grams of Spongilla powder, 0.2 grams of green algae powder, 5.0 milliliters of 3% hydrogen peroxide. This professional skin surface regeneration formulation mixture and application involves mixing the powder with a hot liquid just prior to use. The contents are then applied to the face or other affected area in a circular motion for about 5 minutes. The mixture is then allowed to dry for 25-30 minutes and then washed off with water. Recommended usage is once a week.

(Example 5)
(Topical oily skin treatment)
Formulas for the treatment of oily skin may include 1.0 grams of Spongilla powder and 2.0 milliliters of chamomile water, menthol water or calendula water. The blending and application of this professional skin surface regeneration formulation involves mixing the powder with a warm liquid just prior to use. Let the contents stand for 5 to 10 minutes, then wash off with water. The recommended usage is every 2 days until sebum production is suppressed and then every 10 days for maintenance.

(Example 6)
(Topical deep skin exfoliation skin treatment)
A formulation for deep skin exfoliation may consist of 1.5 grams Spongilla powder, 0.3 grams green algae powder, and 5.0 milliliters of 4% hydrogen peroxide. This specialized deep skin exfoliation formulation mixture and application involves a 7 day process. On day 1, steam the face or affected area. The powder is mixed with hot liquid just before use. The contents are then applied to the face or other affected area in a circular motion. After 5 to 6 minutes, hydrogen peroxide is soaked in a mask ni circular motion. This is left to dry for 20 minutes and washed off with water. On the second day, the face or affected area is washed with 2% salicylic acid. The contents are then applied to the face or other affected area in a circular motion. After 5 to 6 minutes, the mask is immersed in hydrogen peroxide by circular motion. This is left to dry for 20 minutes and washed off with water. On days 3 and 4, boric ointment is applied to the affected area. On the 5th and 6th days, apply a moisturizer and soothing mask. On the seventh day and the last day of treatment, the affected area is rubbed and peeled off. Recommended usage is once a month.

(Example 7)
(Treatment of hyperpigmentation disorder)
The formulation for removal of over-pigmented spots on the skin (including but not limited to melanosis, age spots, sun damage, etc.) is 1.0 grams Spongilla powder, 0.2 grams white It can consist of algal powder and 3.0 milliliters of enzyme gel. The contents are then mixed together and applied to the face or other affected area with a circular massage for about 10 minutes and allowed to dry for 25-30 minutes. Then wash off with water. Recommended usage is twice a week.

(Example 8)
(Treatment for light damage and age-related skin)
A formulation for light damaged skin may consist of 2.0 grams of Spongilla powder and 5.0 milliliters of jojoba oil. Mixing and applying the prescription for light damage and aging skin involves mixing the powder with hot oil just prior to use. The contents are then massaged into the face or other affected area with a circular motion for 30-45 minutes, allowed to stand for 25-30 minutes, and then rinsed off with water. Recommended usage is once a week.

Example 9
(Treatment for seborrheic dermatitis of scalp)
The formulation for scalp seborrheic dermatitis contains 5.0 grams of Spongilla powder, 5.0 milliliters of 3% hydrogen peroxide and 5.0 milliliters of 2% boric acid. This professional skin surface regeneration formulation mixture and application involves mixing the powder with a hot liquid just prior to use. The contents are then applied to the affected area while massaging with a circular motion. The mixture is then left for 30 minutes and then washed off with water. Recommended usage is 5-6 days in 8-10 weeks, then once a month for maintenance.

  The foregoing exemplary embodiments are not intended as limitations and the sponge composition of the present invention can be formulated in various ways and still be considered to be within the scope of the present invention. We believe that dried Spongilla powder contains a number of biologically active compounds that are beneficial in promoting skin health and promoting scar healing and reduction. These beneficial compounds include, in addition to inorganic compounds such as iodine, bromine, phosphorus and sulfur, antibacterial factors, anti-inflammatory factors, antiviral factors and other organic bioactive factors. Cannot be limited.

  The exact mechanism of action of the Spongilla composition of the present invention remains unknown. In addition, the inventors believe that the natural combination of ingredients contributes to a synergistic effect, which can be destroyed or significantly reduced by extraction and purification of the active ingredient. However, the inventors have demonstrated the safety and effectiveness of the present invention as detailed in the following non-limiting disclosure.

(Safety test)
(1. In vivo rabbit test)
Test article Desiccated Animal Sponge-Thitle, Batch: San Pin 2.3.2.560-96, International Organization for Standardization 10933: Biological evaluation of medical devices, Chapter 10: For irritation and sensitization The primary skin irritation was evaluated according to the test guidelines. Two 0.2 g portions of test article and vehicle control article moistened with 5 drops of 0.9% sodium chloride were each applied topically to the skin of 3 rabbits each and left in place for 24 hours. The sites were classified for erythema and edema 1 hour, 24 hours, 48 hours and 72 hours after removal of a single sample application. Under the conditions of this study, no erythema or edema was observed in the rabbit skin. The Primary Irritation Index for this test article was calculated as 0.0. The response of this test article was classified as negligible.

  The test articles identified below were evaluated for primary skin irritation according to International Standards Organization 10933: Biological Evaluation of Medical Devices, Chapter 10: Test Guidelines for Irritation and Sensitization. The purpose of this study was to determine the potential to irritate rabbit skin for a single topical application of the test article. This test article was received on August 30, 2002. The patch was applied on September 5, 2002 and the observations concluded on September 9, 2002 were made in accordance with the provisions of FDA Pharmaceutical Safety Testing Practice (GLP) Rule 21, Federal Regulatory Standard 58.

(material)
Test article: Desiccated Animal Sponge-Thistle Identification number: Batch: San Pin 2.3.2.506-96
Stability test: completed and recorded by sponsor (by sponsor)
Expiration date: April 2004 Vehicle: 0.9% sodium chloride, sterile saline Storage conditions: Dry, dark conditions:
Control article: Quadruple gauze supplied from the test facility was cut into 25 mm x 25 mm pieces and moistened with 5 drops of 3% hydrogen peroxide per piece.
Preparation: A 0.2 gram portion of the test article (weighed by sponsor prior to submission), Desiccated Animal Sponge-Tistle, was moistened with 5 drops of 0.9% sodium chloride. The test article and saline were mixed to form a uniform paste. The test mixture was applied to the animal's skin, allowed to air dry for 20 minutes, and then wrapped with quadruple gauze.
Test system: Male rabbit (Oryctolagus Cuniculus), New Zealand.

(Experimental procedure)
On the day before treatment, the back hair of each rabbit was trimmed with an electric clipper. On the day of treatment, 4 sites on each rabbit were marked (2 on both sides of the back and on the head and tail). This site was free of stains that could interfere with the interpretation of the results.

  A 0.2 g portion of the test article was wetted with 5 drops of saline and applied to an approximately 25 mm × 25 mm square portion of each tail (2 locations per rabbit). The test article mixture was allowed to air dry for 20 minutes before wrapping. A control vehicle was similarly applied to the tail. Each animal's torso was wrapped with an elastic band to keep the test patch in place. After treatment, the animals were returned to their cages.

  After 24 hours of exposure, the bands, tapes, and patches were removed. In an attempt to remove any remaining residue, the site was gently wiped with a gauze sponge moistened with deionized water. Skin observations for erythema and edema were recorded 1 hour, 24 hours, 48 hours, and 78 hours after patch removal.

  After completing the study for each animal, the primary stimulus index for this study was calculated. Erythema and edema scores obtained at 24, 48 and 72 hour intervals were added together and divided by the total number observed. This calculation was performed separately for each test article and control article for each animal. The score for the control was subtracted from the score for the test article to obtain a Primary Irritation Score. The primary stimulation scores for each rabbit (see Table 2) were added together and divided by the number of rabbits to obtain the primary stimulation index (see Table 3).

(result)
As summarized in Table 1, no irritation was observed in the rabbit skin. The maximum stimulation response was not applicable. The primary stimulus index for this test article was calculated to be 0.0. The calculation of this stimulus is shown below:

（安全性試験：結論）
本研究の条件下では、ウサギの皮膚において、紅斑および水腫は何も観察されなかった。上記試験物品に対する一次刺激インデックスを、０．０であると計算した。この試験物品の応答を、無視できると分類した。

(Safety test: conclusion)
Under the conditions of this study, no erythema and edema were observed in the rabbit skin. The primary stimulus index for the test article was calculated to be 0.0. The response of this test article was classified as negligible.

(II. Guinea pig test in vivo)
The test articles described below were evaluated for potential delayed skin contact sensitization after repeated application of occlusive patches in guinea pigs. This study was based on the International Organization for Standardization 10993: Biological evaluation of medical devices, Chapter 10: Irritation and sensitization testing requirements. This test article was received on August 30, 2002. The first patch was applied on September 17, 2002 and the observation was completed on October 22, 2002. The sensitivity of the Hartley guinea pig line to 1-chloro-2,4-dinitrobenzene (DNCB), a known sensitizer, has been demonstrated.

  This study was conducted in accordance with the provisions of FDA Pharmaceutical Safety Testing Practices Standard (GLP) Regulation 21, Federal Regulation Standard 58.

(material)
Test article: Desiccated Animal Sponge-Thistle
Identification number: Batch: San Pin 2.3.2.560-96
Stability test: completed and recorded by sponsor (by sponsor)
Expiration date: April 2004 Storage condition: Dry, dark condition control article: Approximately 25 mm x 25 mm piece of quadruple gauze was used as vehicle.
Preparation: A 0.2 gram portion of a test article (weighed by sponsor prior to submission), Desiccated Animal Sponge-Tistle, was moistened with 5 drops of 3% hydrogen peroxide. The test article and hydrogen peroxide were mixed to form a uniform paste. A 0.2 grain portion of the test article mixture was used for about 5 patches applied to the skin of the animals. The test mixture was air dried for 20 minutes and then wrapped in quadruple gauze.
Species: female guinea pig (Caviar porcellus) Crl: (HA) Charles River Laboratories, weight range: 311 to 366 grams the day before the first treatment.

  This Hartley white guinea pig has historically been used for sensitization studies. The test article is repeatedly patched onto the undamaged skin. Topical application relates to the route of exposure to a person and allows assessment of the potential sensitization of skin contact and / or absorption during the induction and challenge phases. The reaction directly under the local application site can be observed. The sensitivity of the Hartley strain to 1-chloro-2,4-dinitrobenzene (DNCB), a known sensitizer, has been demonstrated.

(Experimental procedure)
Each animal was weighed and identified the day before the first induction treatment. Hair was removed using an electric clipper from the left flank of 10 guinea pigs designated as test animals and 5 guinea pigs designated as control animals. Each animal was observed daily for general health.

  The next day, an aliquot of the test mixture was applied to an approximately 25 mm x 25 mm area of the appropriate animal. The test mixture was allowed to dry for 20 minutes before wrapping. The patch was then fixed to intact skin with hypoallergenic tape. To maintain the plugged patch in place, the body of each guinea pig was wrapped with elastic bands.

  The wraps and patches were removed in 6-8 hours. After removing the patch, the site was wiped with dry gauze to remove any residue from the skin. Observations for skin response were recorded for 24 hours after exposure of each test article was completed. Prior to scoring, the site was wiped with gauze soaked in 35% isopropyl alcohol.

  The application procedure was repeated 3 times weekly (eg, Monday-Wednesday-Friday) for 3 weeks until 9 applications were made to the animal's left flank. The hair was shaved the day before each application to provide a clear site.

  Thirteen days after the last induction patch, the hair of each guinea pig was removed from the right flank region with an electric clipper. The next day, approximately 25 mm x 25 mm pieces of both control and test articles were applied to the dorsal and ventral regions of the right flank and ventral region of each test guinea pig and control guinea pig. Each guinea pig's torso was wrapped with an elastic band to keep the closed patch in place.

  All wraps and patches were removed after 6-8 hours. The site was wiped with dry gauze before removing the patch. 24 hours after removal of the patch, the challenged site and surrounding area were shaved. Observations for skin reaction were made 2-4 hours after shaving and patches were removed 48-72 hours after challenge. Sites were wiped with gauze soaked in 35% isopropyl alcohol before scoring at each interval. Assessments for both induction and challenge phases were based on scored skin responses, as summarized in Table 4 below.

チャレンジパッチの後、コントロール条件のチャレンジにおいて観察されるよりも大きい皮膚の反応を示す任意の試験動物を、試験物品に対する遅延型接触感作性を示すとみなした。反応のパターンおよび持続期間もまた、最終的な評価において考慮した。

After the challenge patch, any test animal that showed a greater skin response than observed in the control condition challenge was considered to exhibit delayed contact sensitization to the test article. Response patterns and duration were also considered in the final evaluation.

(result)
(Clinical findings)
The individual body weights are shown in Appendix 1. All animals appeared to be clinically normal throughout the study.

(Skin knowledge)
The individual results of skin scoring for induction and challenge phases are shown in Tables 5 and 6. No evidence of sensitization was observed. All procedures were performed in accordance with pharmacovigilance standards and ISO 17025.

（安全性試験：結論）
本研究の条件下で、本発明のＳｐｏｎｇｉｌｌａ治療用組成物は、モルモットにおいて何も遅延型皮膚接触感作性を示さなかった。従って、本発明の教示に従ってＳｐｏｎｇｉｌｌａ調製物が調製された場合、レシピエントにおいて誘導される、証明できる毒性反応およびアレルギー反応は何もなかった。

(Safety test: conclusion)
Under the conditions of this study, the Spongilla therapeutic composition of the present invention did not show any delayed skin contact sensitization in guinea pigs. Thus, when a Spongilla preparation was prepared according to the teachings of the present invention, there were no demonstrable toxic and allergic reactions induced in the recipient.

(Exemplary methods for using the sponge composition of the present invention)
(Introduction)
A pre-weighed package is provided that contains substantially pure Spongilla powder. The pre-weighed amount is sufficient for a single application on the face. Alternatively, this application can be used for treatment of the chest, neck, or shoulder instead of the face. This procedure may be performed by a doctor, nurse or patient trained in this procedure. This can be safely applied to patients of all skin types.

Patients should be informed to avoid unprotected sun exposure for 2 weeks before each treatment. Products such as glycolic acid (over-the-counter medication strength), Retin A and Renova should be discontinued for at least 14 days prior to treatment. Professional strength glycolic acid exfoliation, exfoliation of Jessner, phenol exfoliation and TCA exfoliation; after CO ₂ laser resurfacing and Erbium laser exfoliation, should a long period of time (several months) is allowed to elapse. However, each case can be tested individually in the clinic.

  After the application is removed, the treatment area must be washed with a mild detergent. The person performing this procedure can wear protective gloves (this is not necessary).

(Treatment preparation)
Weigh out 2 milliliters of 3% hydrogen peroxide and place in a small (approximately 30-50 ml) non-metallic container. Gently heat in the microwave to bring the solution to a slightly warm temperature. Using a 1300 watt microwave, the time setting is typically 2-10 seconds, depending on whether the container is glass or plastic. Pour the warmed peroxide solution into a pre-weighed container of Spongilla powder. Gently stir to obtain a completely uniform and uniform thin paste. Alternatively, the powder can be first mixed with hydrogen peroxide and then warmed.

(Treatment application)
Massage into a circular motion and apply a quarter amount in the middle of the forehead. Gently spread this paste with your fingers in a small circular motion to the hairline with equal pressure. When the paste begins to dry, repeat the same process with the temples, cheeks, nose and chin lowered. Mild to moderate erythema usually appears. The sensation of a sharp crystal needle is commonly experienced during the procedure. It is best to avoid the area around the orbit. This is because the skin around the orbit is thinner and more sensitive. In order to optimize the penetration of the active ingredient into the skin, it is very important to massage the paste into the skin before the paste dries. This can take 5 minutes for the face. The neck and chest should usually be done last. The most comfortable way to rinse the face is to apply cold water to the patient rather than wiping the patient's face with a wet cleaning cloth. The erythema of the skin and the tingling sensation of the skin gradually disappear over the next 12-24 hours.

^＊処置時間は変動し得る。患者が痛みおよび不快感を覚えた場合は、即座に中止する。即座に冷水で皮膚を洗浄する。

^* Treatment time can vary. If the patient feels pain and discomfort, stop immediately. Immediately wash skin with cold water.

  At least two weeks after each treatment, patients are instructed to use an SPF 30-40 sunscreen, preferably one that contains zinc to help soothe the skin. Explain that failure to do so can result in hyperpigmentation. For best results, patients should avoid applying humectants for at least 12 hours. Concentrated humectants must be avoided during the course of treatment. The use of powder makeup and light foundation can be resumed after the first 12 hours. All patients must be instructed to perform exfoliation using a scrub provided at home or return to the clinic for the exfoliation procedure on days 5-6.

(Efficacy test)
In one embodiment of the present invention, the patient shown in FIG. 2 was treated using a therapeutic composition prepared from dry Spongilla powder and formulated as disclosed above. More specifically, the topical therapeutic agent was mixed prior to use and heated in a microwave for 7 seconds, 1.0 gram Spongilla powder and 2.0 milliliters of 3%
Formulated as a topical acne treatment consisting of hydrogen peroxide. This topical composition was applied to the entire face in a circular motion under the supervision of a trained physician. The treatment was left for 25 minutes in contact with the patient's skin and then rinsed with water. This treatment protocol was repeated every 7 days for 4 weeks. After completing the treatment, the patient appeared as shown in FIG.

  The therapeutic compositions of the present invention are derived from sponge species and can be used to treat various skin diseases and disorders. Specifically, the present invention provides a topical therapeutic agent derived from Spongilla. This topical treatment includes rosacea, seborrheic dermatitis, eczema (atopic dermatitis), psoriasis, photoaging, actinic keratosis, many other bacterial diseases, viral diseases, and fungi It is effective in the treatment of sex diseases and skin pigmentation disorders. Several exemplary embodiments have been provided; however, many other compositions are possible by those skilled in the art of pharmaceutical formulation without departing from the spirit of the claimed invention. Understood.

  Unless otherwise indicated, all numbers representing the amounts of ingredients, properties such as molecular weight, reaction conditions, etc. used in the specification and claims are modified by the term “about” in all cases. Should be understood as being. Accordingly, unless indicated otherwise, the numerical parameters set forth in the following specification and appended claims are approximations that may vary depending upon the desired properties sought by the present invention. At a minimum, and not as an attempt to limit the application of equivalent doctrines to the claims, each numeric parameter takes into account at least the reported significant digits and general rounding It should be interpreted by applying technology. Although the numerical ranges and parameters describing the broad scope of the invention are approximate, the numerical values set forth in the specific examples are reported as accurately as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

  The terms “a” and “an” and “the” and similar designations used in the context of the description of the invention (especially in the context of the following claims) are referred to herein. Unless otherwise indicated, or unless clearly contradicted by context, this should be interpreted as covering both the singular and plural. The recitation of value ranges herein serves only as a convenient way of referring individually to each distinct value within the range. Unless otherwise indicated herein, each individual value is incorporated herein as if it were individually listed herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples provided herein, or the use of exemplary terms (eg, “such as”) is merely intended to illustrate the present invention well. And does not present a limitation on the scope of the invention as separately claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

  The classification of alternative elements or embodiments of the invention disclosed herein should not be construed as limiting. The members of each group can be individually mentioned and claimed, or any combination with other members or other elements of the group is found herein. It is anticipated that one or more members of a group may be included in or removed from the group for convenience and / or patentability reasons. In the event of any such inclusion or deletion, the specification is deemed to include the modified groups herein, thereby describing all Markush groups used in the appended claims. Realize the explanation.

Preferred embodiments of the present invention include the best modes described herein and known to the inventors for practicing the present invention. Of course, variations on those preferred embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect that those skilled in the art will appropriately utilize such variations, and the inventors have determined that the invention is different from that specifically described herein. It is intended to be implemented in a method. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

  In closing, it is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that can be utilized are within the scope of the invention. Thus, by way of example and not limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that which is shown and described exactly as described.

Claims (1)

Invention described in the specification.

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