US 20070292530A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2007/0292530 A1 Dinno (43) Pub. Date: Dec. 20, 2007

(54) TOPICAL COMPOSITION AND METHOD Publication Classification FOR THE TREATMENT AND PROPHYLAXIS (51) Int. Cl. OF DERMAL RRITATIONS A6IR 33/30 (2006.01) A6IP 7/00 (2006.01) (52) U.S. Cl...... 424/642 (76) Inventor: Raied Dinno, Weston, MA (US) (57) ABSTRACT Correspondence Address: A composition and method for the prevention and therapeu tic treatment of skin conditions and disorders are disclosed. WEINGARTEN, SCHURGIN, GAGNEBIN & The composition and method of the invention are particu LEBOVC LLP larly directed to the treatment and prevention of dermal TEN POST OFFICE SQUARE irritations. These irritations include, for example, psoriasis, BOSTON, MA 02109 (US) eczema, ichthyosis, pruritus, dryness and dermatitis, which may cause skin to crack, chap or chafe. The composition and method are particularly useful in treating and preventing (21) Appl. No.: 11/827,369 diaper dermatitis. A therapeutic composition according to the invention includes an agent, which is an enzyme con stituent, promoting the synthesis of collagen and the repro (22) Filed: Jul. 11, 2007 duction of cells, particularly skin cells. Such therapeutic agents include, for example, Zinc oxide. This agent is generally nonprescription and capable of effectively pre Related U.S. Application Data venting and treating diaper dermatitis through local or topical application. Therapeutic compositions according to (63) Continuation of application No. 10/856,740, filed on the invention also include both natural and synthetic com May 28, 2004, now Pat. No. 7.252,846. ponents, which aid in application, use and treatment. US 2007/0292530 A1 Dec. 20, 2007

TOPCAL COMPOSITION AND METHOD FOR and preventing skin conditions and other related dermal THE TREATMENT AND PROPHYLAXIS OF irritations. These conditions and irritations include, for DERMAL RRITATIONS example, psoriasis, eczema, ichthyosis, pruritus, dryness and dermatitis, which may cause skin to crack, chap or chafe. CROSS REFERENCE TO RELATED 0007 Atherapeutic composition according to the inven APPLICATIONS tion includes a therapeutic agent, which is an enzyme 0001. The present application is a continuation applica constituent promoting the synthesis of collagen and the tion of U.S. application Ser. No. 10/856,740, filed May 28, reproduction of cells, particularly skin cells. Such therapeu 2004 and entitled “TOPICAL COMPOSITION AND tic agents include, for example, iron oxide, titanium oxide, METHOD FOR THE TREATMENT AND PROPHY manganese oxide and Zinc oxide. The therapeutic composi LAXIS OF DERMAL IRRITATIONS''. The specification tion is preferably suitable for topical application in a non and contents of U.S. application Ser. No. 10/856,740 are prescription form. When topically applied, the composition incorporated herein by reference in entirety. is effective for treating and preventing diaper dermatitis. The composition may also include an effective combination of BACKGROUND OF THE INVENTION ingredients, such as, for example, those that are organic and synthetic, which aid in application and use as well as 0002 Skin is the largest organ of the human body. In treatment and prevention. general, human skin includes two layers, an outer layer and an underlying layer. The outer layer is known as the epi 0008. In addition, the invention is directed to a method dermis, and the underlying layer is referred to as the dermis. for preparing or compounding the therapeutic composition. The dermis is a connective layer that is responsible for the A method for applying the composition to a dermal area is elasticity of skin. The epidermis primarily functions to also encompassed. Finally, the therapeutic composition is regulate secretion and body temperature, and protect against incorporated with an article of manufacture. This article may dehydration and infection. Skin aliments or disorders, how be a packaging material or a device. ever, tend to retard the functions of the epidermis, and may limit the outer layer's ability to protect the body. Moreover, Definitions skin conditions and dermal irritations are a common prob 0009. The terms “therapeutic composition' or “compo lem for many individuals. sition' generally refer to a composition of the invention. 0003. Although there are numerous skin conditions These terms may refer to any composition suitable for known in the field of dermatology, conditions that normally treating and preventing different skin conditions. Similarly, affect individuals include psoriasis, eczema, dryness and the terms may refer to any form of the composition, such as, dermatitis. One form of dermatitis that is particularly prob for example, an ointment, salve, lotion or cream. lematic and known to reoccur with frequency is diaper 0010) The terms “topical” or “topically” generally refer dermatitis. Diaper dermatitis or diaper rash inflames and to the manner in which the preferred therapeutic composi irritates those dermal parts of the body which are generally tion is applied to the epidermis of the skin. proximate to or covered by a diaper. This inflammation and irritation may cause skin to, for example, crack, chap or 0011. The terms “activity” or “active” generally refer to chafe. the efficacy of an ingredient or composition exhibited during application, particularly topical application. For example, 0004 The pharmaceutical and cosmetics industries are one activity associated with tea tree oil is that it is a natural both concerned with treating diaper rash and its effects. A antiseptic. number of topical products are available to consumers for this purpose. These products include creams, starches and 0012. The terms “effective combination” or “effective powders. amount generally refer to an amount or combination of ingredients useful in promoting at least one specific activity. 0005 Although generally effective to relieve the discom fort associated with diaper dermatitis, the majority of avail For example, an effective amount or quantity of Zinc oxide able topical products do not include nonprescription thera is active in promoting skin cell reproduction. peutic agents for treatment and prevention. Similarly, 0013 The terms “dermal irritation” or “dermal irrita therapeutic agents are not available in products having both tions' generally refer to a skin condition or irritation of the organic and synthetic components, which aid in application epidermis. Such conditions include, for example, psoriasis, and use as well as treatment and prevention. In addition, eczema, dryness and dermatitis, which may cause skin to these products are not effective in treating or preventing crack, chafe, chap, inflame or dry. other related skin conditions. Products are also not available which are easy to apply to different areas of the body. For DETAILED DESCRIPTION OF THE example, a topical talc presents application problems with INVENTION out the use of a carrier that remains in contact with the skin. Finally, the increasing costs of Such products tends to limit 0014. The present invention is effective for treating and preventing a variety of skin conditions. In one embodiment, COSU U.S. the invention is directed to a therapeutic composition includ SUMMARY OF THE INVENTION ing an effective combination for the treatment and preven tion of dermal irritations, particularly diaper dermatitis. The 0006 The present invention is directed to the treatment ingredients of the effective combination each exhibit at least and prophylaxis of skin aliments and disorders. Particularly, one activity, which promotes the treatment and prevention of the disclosed composition and method are useful in treating a skin malady. For example, a moisturizer may be active as US 2007/0292530 A1 Dec. 20, 2007

an emollient as well as a softener of the epidermis. The are understood to be a suitable substitute or supplement for therapeutic composition is also suitable for topical applica the preferred ingredients of the composition, such as, for tion, although other means of application are recognized by example, an antiseptic. those of ordinary skill in the art, Such as, for example, a local 0020. An additional embodiment of the therapeutic com injection. position includes an effective combination of mineral oil, 00.15 Preferably, the therapeutic composition includes an Zinc oxide, quaternium-18 hectorite, magnesium hydrox effective combination of a therapeutic agent, an adhesive ide, cod liver oil, gum karaya powder, propylene carbonate, agent, an emulsifier, an antiseptic, a moisturizer, a buffering tea tree oil, aloe Vera and lanolin. These ingredients may agent, an emollient, a lubricating agent, an anesthetic and a each be present in an amount or quantity effective to treat carrier. An effective combination may require that each and prevent different skin conditions. Similarly, the amount ingredient be present in an amount or quantity Suitable for or quantity of these ingredients may vary depending, for the treatment and prevention of different skin conditions. example, on a specific condition or treatment. The amount or quantity of each ingredient, however, may 0021 According to the invention, an effective combina vary depending on several factors, such as, for example, the tion of ingredients may include about 33% by weight skin condition being treated. mineral oil, about 30% zinc oxide, about 25% quaternium 18 hectorite, about 3.0% magnesium hydroxide, about 2.5% 0016. In one embodiment, the therapeutic agent may be cod liver oil, about 2.0% gum karaya powder, about 2.0% provided in an amount primarily effective to promote the propylene carbonate, about 1.5% tea tree oil, about 0.5% synthesis of collagen, and the adhesive agent may be an aloe Vera and about 0.5% lanolin. The weight percentages of amount primarily effective to heal opened skin. Similarly, these ingredients may vary based on, for example, the the emulsifier may be an amount primarily effective to addition of other ingredients or the skin condition being promote a uniform distribution, and the antiseptic may be an treated. amount primarily effective to cleanse a dermal area. The moisturizer may also be provided in an amount primarily 0022. It is preferable that the therapeutic agent of the effective to moisturize a dermal area, and the buffering agent composition be Zinc oxide. Zinc oxide acts as an enzyme may be an amount primarily effective to reduce acidity. constituent, which promotes the synthesis of collagen and Moreover, the emollient may be an amount primarily effec aids in the reproduction of cells. Skin cell reproduction is tive to soften a dermal area, and the lubricating agent may beneficial for replacing those cells damaged by different be an amount primarily effective to lubricate a dermal area. maladies, such as, for example, dermatitis. It is appreciated Finally, the anesthetic may be provided in an amount pri that Zinc oxide also acts as a mild astringent and a barrier marily effective to soothea dermal area, and the carrier may agent to Soothe dermal irritation and protect the epidermis. be an amount primarily effective to carry the effective Other therapeutic agents that may be used include, but are combination for application, particularly topical application. not limited to, titanium oxide, iron oxide and manganese oxide. Various combinations of these therapeutic agents may 0017. The preferred therapeutic composition may be in also be used. Similarly, these agents may be added to the any form Suitable for topical application. In one embodi composition in any suitable form, Such as, for example, a ment, the composition is an ointment. The composition may powder. also, for example, be compounded or blended to be applied 0023 Zinc oxide is a natural therapeutic agent, although as a salve, cream or a paste. As an ointment, the composition it may also be chemically synthesized. The ease with which has a consistency Suitable for uniform dermal application. Zinc oxide is topically applied makes the agent remarkably Additionally, the ointment may be substantially viscous to effective for treating and preventing skin conditions, par remain in contact with the skin regardless of perspiration, ticularly diaper dermatitis. Other conditions treatable with excess moisture or environmental conditions. Zinc oxide include, for example, psoriasis, eczema, ichthyo 0018. One advantage of the therapeutic composition sis, pruritus, dryness and dermatitis, which may cause skin according to the invention is that topical application is to crack, chap or chafe. particularly convenient for treating and preventing a variety 0024. The natural and synthetic ingredients according to of skin conditions. The preferred therapeutic composition the invention are useful in applying the composition to the may be noninvasively applied directly to the skin condition epidermis as well as treating and preventing different skin regardless of the accessibility or sensitivity of a dermal area. aliments. Such natural ingredients may include, for example, The composition also remains in contact with the skin mineral oil, cod liver oil, gum karaya powder, tea tree oil, without the need for an additional carrier or gauze. For aloe Vera and lanolin. Synthetic ingredients may also example, a talc or powder may not remain in contact with the include, but are not limited to, quaternium—18 hectorite, skin for an entire period of use, particularly when used under magnesium hydroxide and propylene carbonate. severe environmental conditions. 0025. Another advantage of the present invention is that 0019. During topical application, the therapeutic compo the ingredients of the therapeutic composition are generally sition aids the skin in absorbing moisture and hydrating a available to pharmacists and consumers. Specifically, ingre dermal area. This activity may be promoted by hydrophilic dients, such as, for example, mineral oil, Zinc oxide, quate ingredients. The composition may also include hydrophobic mium—18 hectorite, magnesium hydroxide, cod liver oil, compounds, which prevent moisture loss. In addition, the gum karaya powder, propylene carbonate, tea tree oil, aloe composition of the invention may include, for example, Vera and lanolin may each be used in nonprescription Surfactants, anti-inflammatory agents, perfumes, solvents, strength. natural oils, fruits, coloring agents, water and vitamins 0026. The ingredients of the preferred composition may including, but not limited to, antioxidants. These ingredients be pharmaceutically compounded in any suitable form. Gum US 2007/0292530 A1 Dec. 20, 2007

karaya, for example, may be compounded as a powder or a suffering from a specific condition. Moreover, these meth colloidal dispersion. It is recognized that the effectiveness of ods allow formulation changes based on the severity of the treating and preventing different skin conditions may vary skin condition being treated. In one embodiment, the method depending on the compounded composition form. More is directed to compounding an effective combination of over, it will be appreciated that these ingredients may have ingredients including, but not limited to, mineral oil, Zinc specific activities associated with treatment and prevention. oxide, quatemium-18 hectorite, magnesium hydroxide, For example, aloe Vera is effective in moisturizing the cod liver oil, gum karaya powder, propylene carbonate, tea epidermis and it is a soothing topical anesthetic, an anti tree oil, aloe Vera and lanolin. inflammatory agent and a dermal cleansing aid. 0033 Different pharmaceutical compounding methods 0027 Additionally, magnesium hydroxide may protect may yield specific forms of the preferred composition. The the epidermis from acidic feces and urine as a buffer agent therapeutic composition may be compounded into, for in the preferred composition, although it is also understood example, a solution, Suspension, gel, cream, ointment, lotion by one of ordinary skill in the art to be an effective or stick. Compounding may also involve blending the ingre anesthetic. Similarly, tea tree oil cleanses the epidermis by dients into a particular form Suitable for topical application washing away urine, feces, dirt, blood or other contami or other delivery methods. nants. What is more, tea tree oil is also effective as an 0034. One embodiment of the invention is directed to a antiseptic and an antimicrobial agent that inhibits the growth method for treating and preventing skin aliments, particu of microorganisms, which tend to cause infection and larly diaper dermatitis. The method includes providing the inflammation. preferred therapeutic composition and applying it in an 0028. Other ingredients useful in preventing inflamma amount or quantity Sufficient to cover a dermal area expe tion and cleansing, lubricating or protecting the epidermis riencing irritation. The method may also include spreading include, for example, cod liver oil and gum karaya powder. the composition topically onto the irritated area and reap Cod liver oil may reduce topical inflammation as well as plying it to provide for a uniform distribution. It will be lubricate the skin. Similarly, gum karaya powder protects the appreciated that the composition may be applied as often or epidermis and also acts as an adhesive to heal opened skin. as long as required for proper treatment. Although this Such ingredients may also promote a specific activity method is specific to topical application, numerous other through different mechanisms. For example, lanolin may delivery methods are contemplated, such as, for example, moisturize skin by absorbing water from the environment as transdermally. well as inhibiting the loss of water through the epidermis. 0035. The invention is also directed to an article of 0029. The preferred ingredients according to the inven manufacture including a packaging material for containing tion may also act in concert to improve their efficacy for the preferred composition. The packaging material may different activities. Propylene carbonate and quaternium comprise a label with instructions for use of the therapeutic 18 hectorite, for example, may both act together as an composition. Similarly, in another embodiment, the article emollient or emulsifier. These ingredients may also be of manufacture may be a device incorporating the compo concurrently effective as an emollient and an emulsifier. sition. Moreover, the device may be used to deliver an effective amount of the composition to a dermal area. 0030 Generally, the preferred composition is topically Examples of Such devices include medical devices, under delivered to the epidermis through a carrier. A common garments, implants, hypodermics or hygiene related devices. carrier is mineral oil, which is also presumed to promote the activities of other ingredients. Alternatively, a different 0036) The examples herein are presented to illustrate other advantages of the present invention and to assist one carrier may be therapeutically inert or a fabric article. These of ordinary skill in the art in making and using the preferred different carriers may include, for example, talcs, water, therapeutic composition. These examples are not intended in gauZes or Sucrose. any way to otherwise limit the scope of the disclosure. 0031. An alternate embodiment of the composition may also include an antifungal agent. Such agents are effective EXAMPLE I for treating fungal and yeast related infections. Topical antifungal agents may be available without a prescription, 0037 According to the present invention, a therapeutic although serious infections generally require a prescribed composition that is effective for treating and preventing a agent. A prescription may also be required depending on the variety of skin conditions is prepared as follows: condition or patient being treated. According to the inven tion, it is preferred that an antifungal agent be compounded or blended with the therapeutic composition as an ointment Composition Ingredients Weight Percentages or cream. Suitable antifungal agents include, but are not Mineral Oil About 1.0% To About 50% limited to, amphotericin B, butoconazole, clotrimazole, flu Zinc Oxide About 1.0% To About 50% conazole, miconazole, ketoconazole, flucytosine, terbin Quaternium-18 Hectorite About 1.0% To About 50% afine, itraconazole and terconazole. Magnesium Hydroxide About 0.01%. To About 25% Cod Liver Oil About 0.01%. To About 25% 0032. The therapeutic composition of the invention is Gum Karaya Powder About 0.01%. To About 25% prepared without difficulty from standard pharmaceutical Propylene Carbonate About 0.01%. To About 25% Tea Tree Oil About 0.01%. To About 25% compounding methods. One of ordinary skill in the art will Aloe Vera About 0.01%. To About 25% appreciate the variety of compounding methods that may be Lanolin About 0.01%. To About 25% used for formulation. These compounding methods allow the composition to be prepared for a particular consumer US 2007/0292530 A1 Dec. 20, 2007

0038. This composition may be, for example, pharma EXAMPLE VII ceutically compounded, blended or both such that its con 0045. A preferred therapeutic composition was adminis sistency and form are that of an ointment. tered to an infant suffering from diaper dermatitis. The infant was known to experience a reoccurrence of diaper dermatitis EXAMPLE II approximately every month. Topical application of the com 0.039 Atherapeutic composition of the present invention, position for two days appeared to be effective in treating and which is effective for treating and preventing a variety of preventing the condition, as well as the associated inflam skin conditions, is prepared as follows: mation and irritation. 0046 While the present invention has been described in conjunction with a preferred embodiment, one of ordinary Composition Ingredients Weight Percentages skill, after reading the foregoing specification, will be able to effect various changes, Substitutions or equivalents, and Mineral Oil About 33% Zinc Oxide About 30% other alterations to the compositions and methods set forth Quaternium-18 Hectorite About 25% herein. It is therefore intended that the protection granted by Magnesium Hydroxide About 3.0% Letters Patent hereon be limited only by the definitions Cod Liver Oil About 2.5% contained in the appended claims and equivalents thereof. Gum Karaya Powder About 2.0% Propylene Carbonate About 2.0% Tea Tree Oil About 1.5% What is claimed is: Aloe Vera About 0.5% 1. A therapeutic composition, the composition compris Lanolin About 0.5% ing: a therapeutic agent in an effective amount to promote the 0040. This composition may be, for example, pharma synthesis of collagen; ceutically compounded, blended or both such that its con an adhesive agent in an effective amount to heal opened sistency and form are that of an ointment. skin; EXAMPLE III an emulsifier in an effective amount to promote a uniform 0041. The therapeutic composition according to the distribution of the composition; invention was used to treat an infant Suffering from diaper an antiseptic in an effective amount to cleanse a dermal dermatitis. The infant was known to experience a reoccur area, rence of diaper dermatitis approximately every week. Topi cal application of the composition for one day appeared to a moisturizer in an effective amount to moisturize the be effective in treating and preventing the diaper dermatitis, dermal area; as well as the inflammation and irritation associated with the a buffering agent in an effective amount to reduce acidity; condition. an emollient in an effective amount to promote Smooth EXAMPLE IV application; 0.042 A preferred therapeutic composition was adminis a lubricating agent in an effective amount to lubricate the tered to an infant suffering from diaper dermatitis. The infant dermal area; was known to experience a reoccurrence of diaper dermatitis an anesthetic in an effective amount to Soothe the dermal approximately every two months. Topical application of the area; and composition for five days appeared to be effective in treating and preventing the condition, as well as the associated a carrier in an effective amount to carry the composition inflammation and irritation. to the dermal area for topical application. 2. The therapeutic composition of claim 1, wherein the EXAMPLE V therapeutic agent is selected from the group consisting of iron oxide, titanium oxide, manganese oxide and Zinc oxide. 0.043 A preferred therapeutic composition was adminis 3. The therapeutic composition of claim 1, further com tered to an infant suffering from diaper dermatitis. The infant prising an antifungal agent in an effective amount to inhibit was known to experience a reoccurrence of diaper dermatitis fungal and yeast related infections. approximately every month. Topical application of the com 4. The therapeutic composition of claim 1, further com position for one day appeared to be effective in treating and prising an anti-inflammatory agent in an effective amount to preventing the condition, as well as the associated inflam inhibit dermal inflammation. mation and irritation. 5. The therapeutic composition of claim 1, further com prising an antimicrobial agent in an effective amount to EXAMPLE VI inhibit microbial growth. 0044) A preferred therapeutic composition was adminis 6. The therapeutic composition of claim 1, wherein the tered to an infant suffering from diaper dermatitis. The infant composition is for the treatment of dermal irritations. was known to experience a reoccurrence of diaper dermatitis 7. A therapeutic composition, the composition consisting approximately every year. Topical application of the com essentially of mineral oil, Zinc oxide, gum karaya powder, position for one day appeared to be effective in treating and tea tree oil and aloe Vera. preventing the condition, as well as the associated inflam 8. The therapeutic composition of claim 7, wherein the mation and irritation. composition is for the treatment of dermal irritations. US 2007/0292530 A1 Dec. 20, 2007

9. The therapeutic composition of claim 7, wherein com 19. A therapeutic composition for the treatment of dermal position is topically applied to a dermal area. irritations by topical application to a dermal area, the com 10. A therapeutic composition, the composition compris position comprising: ing: about 33% by weight mineral oil; from about 1.0% to about 50% by weight mineral oil; about 30% by weight Zinc oxide: from about 1.0% to about 50% by weight Zinc oxide: about 25% by weight quatemium—18 hectorite: from about 0.01% to about 25% by weight gum karaya about 3% by weight magnesium hydroxide: powder, about 2.5% by weight cod liver oil; from about 0.01% to about 25% by weight tea tree oil; and about 2.0% by weight gum karaya powder; from about 0.01% to about 25% by weight aloe Vera. about 2.0% by weight propylene carbonate; 11. The therapeutic composition of claim 10, wherein the composition is for the treatment of dermal irritations. about 1.5% by weight tea tree oil; 12. The therapeutic composition of claim 10, wherein the about 0.5% by weight aloe Vera; and composition is topically applied to a dermal area. about 0.5% by weight lanolin. 13. The therapeutic composition of claim 10, wherein 20. A therapeutic composition, the composition compris mineral oil is from about 20% to about 40% by weight. 14. The therapeutic composition of claim 10, wherein zinc ing: oxide is from about 20% to about 40% by weight. a therapeutic agent from about 1.0% to about 50% by 15. The therapeutic composition of claim 10, wherein weight; gum karaya powder is from about 1.0% to about 10% by an antiseptic from about 0.01% to about 25% by weight; weight. 16. The therapeutic composition of claim 10, wherein tea a moisturizer from about 0.01% to about 25% by weight; tree oil is from about 0.1% to about 5.0% by weight. an anesthetic from about 0.01% to about 25% by weight; 17. The therapeutic composition of claim 10, wherein aloe and Vera is from about 0.1% to about 5.0% by weight. a carrier from about 1.0% to about 50% by weight, 18. The therapeutic composition of claim 10, further wherein the composition is applied topically to a der comprising quaternium—18 hectorite, magnesium hydrox mal area. ide, cod liver oil, propylene carbonate, lanolin or combina tions thereof.