# Patent

## Title
Method and composition for treating burned skin

## Abstract

The present invention relates to a method and composition for treating sunburned skin. The present invention provides a method and composition for applying a mixture of indomethacin and moisturizing lotion topically to sunburned skin. The composition includes a mixture having substantially 100 milligrams of indomethacin per 30 cc of moisturizing lotion. The moisturizing lotion is marketed under the trade name Cetaphil® and includes the following ingredients: purified water, glycerin, hydrogenated polyisobutene, cetearyl alcohol (and) ceteareth-20, macadamia nut oil, dimethicone, tocopheryl acetate, stearoxytrimethylsilane (and) stearyl alcohol, panthenol, famesol, benzyl alcohol, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, and citric acid. It is theorized that the Cetaphil® provides certain pH and viscosity levels which allow for the stabilization and solubilation of the indomethacin within the Cetaphil®. The present invention may also be utilized for treating skin burns caused by radiation therapy and excessive heat.

## Background
The subject application is a continuation-in-part of U.S. patent application Ser. No. 10/636,404 filed on Aug. 7, 2003.


FIELD OF THE INVENTION
The present invention relates to a method and composition for treating burned skin, and more particularly, a method and composition for a topical application of an indomethacin and moisturizing lotion formulation for the treatment of mild to moderate skin burns.
BACKGROUND OF THE INVENTION
Although there has been substantial effort in recent years to reduce or eliminate the risk of sunburn (erythema) produced by certain wavelengths in the ultraviolet (UV) region of the spectrum, there are still circumstances wherein skin becomes exposed to UV radiation. Such exposure may, in some cases, cause sunburn. Such sunburn may cause irritation and pain to the skin thereby leading to the need for having the sunburn treated.
A number of prior art formulations have been developed for the treatment of sunburned skin. However, such treatments have certain disadvantages. For example, sunburn treatments that provide a spray mist or a petroleum-based composition to the sunburned area do not produce a sufficiently large heat transference effect to remove heat from the sunburned area. Furthermore, petroleum-based compositions tend to produce a residue that needs to be subsequently cleansed from the tender and sensitive area of the sunburned skin. Such cleansing tends to cause further discomfort and irritation to the affected skin.
Preferably, a treatment for sunburn would satisfy several objectives simultaneously. The main objective for the treatment of sunburn would be to relieve pain, eliminate the source of heat, stop the burn progression, and, if necessary, help prevent infection. Thus, a useful treatment for sunburn preferably provides immediate relief from pain while also helping to promote healing. It would be desirable to have a formulation for treatment of sunburn to be combined in a reasonably convenient and cost-effective process wherein the prepared composition would remain stable during storage. Such a sunburn formulation should provide the relief and healing effects sought without producing an uncomfortable, sticky sensation and without soiling or sticking to one's clothing. In addition, the sunburn formulation should preferably not produce a residue that must be subsequently washed or removed from the sensitive sunburned area.
Since a sunburn is an inflammatory disorder, sunburn has been treated in the past with anti-inflammatory drugs. One of the most effective therapeutics is indomethacin [1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid], a non-steroid chemical compound that has been widely recognized for its outstanding anti-inflammatory, anti-pyretic, and analgesic properties. However, indomethacin can become unstable when mixed with certain carriers for topical applications, and therefore, oral administration is sometimes the preferred method of administration.
Oral administration of indomethacin has previously been reported as effective in relieving pain, reducing fever, and providing increased mobility in patients with inflammatory disorders, including those of a rheumatic nature. When orally administered, the drug behaves as a systemic medicine that passes into the bloodstream for general distribution in the body. As in the case with numerous other drugs, not every one can satisfactorily accept this drug by the oral mode of administration, particularly over extending periods of therapy. In addition, oral administration does not provide for the direct and concentrated application of indomethacin on an affected area, such as an area of sunburned skin.
Similar deficiencies also exist in the treatment of skin burns as a result of radiation therapy. Past treatments have utilized moisturizing creams or ointments to soothe the skin burns, however, such creams and ointments do not contain active anti-inflammatory or anesthetic agents to reduce pain or itching. Topical hydrocortisone creams or ointments have been utilized to reduce inflammation and discomfort, but such treatments typically provide only temporary relief for up to 1-11⁄2 hours. Topical anesthetic creams or ointments work to reduce pain, but similarly, only provide for the temporary relief of such pain. Other creams, such as silver sulfadiazine cream 1% (sold as Silvadene Cream®), are used to treat radiation burns having blistered areas and ulcerations in order to reduce the pain and incidence of secondary skin infection, however, such creams' effects are limited when applied to first degree burns.
It would be desirable to provide a non-oral method of administering indomethacin for the treatment of sunburned skin. In addition, it would be desirable to provide a carrier vehicle for the topical application of indomethacin whereby local treatment of inflammation is achieved to an area of sunburned skin. It would also be desirable to provide a carrier for indomethacin that provided a topical application which utilized a reasonably convenient and cost-effective process that remained stable during storage. It would be desirable to provide a non-oral method of administering indomethacin for the treatment of mild to moderate skin burns caused by radiation therapy or excessive heat.
SUMMARY OF THE INVENTION
The present invention relates to a method and composition for treating mild to moderate skin burns. The method of the present invention comprises the steps of providing an indomethacin and a moisturizing lotion. The indomethacin and moisturizing lotion are combined to form a mixture for applying the mixture topically to burned skin to relieve the symptoms associated with burned skin. The mixture is applied one to two times daily to the burned skin.
The composition of the present invention provides a mixture of indomethacin and moisturizing lotion. The mixture provides substantially 100 milligrams of indomethacin per substantially 30 cc of moisturizing lotion. The moisturizing lotion may contain emollients and humectants. The moisturizing lotion may also contain purified water, glycerin, hydrogenated polyisobutene, cetearyl alcohol (and) ceteareth-20, macadamia nut oil, dimethicone, tocopheryl acetate, stearoxytrimethylsilane (and) stearyl alcohol, panthenol, farnesol, benzyl alcohol, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, and citric acid. The moisturizing lotion may be marketed under the trade name Cetaphil®.


DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention will now be described in detail with reference to the disclosed embodiment.
The present invention provides a method and composition for treating sunburned skin of a human being. The composition includes a mixture of indomethacin and a moisturizing lotion. The composition is applied topically to the sunburned skin to provide highly effective relief of the symptoms associated with sunburned skin, including the local inflammation caused by the sunburn. It is believed that the skin, with the presence of the topical formulation, acts as a reservoir, absorbing large amounts of the indomethacin and slowly releasing the indomethacin into the skin and to other tissues. The skin may actually act as a depot or reservoir for the indomethacin. It is believed that the indomethacin is stabilized and solubilized by the moisturizing lotion wherein the moisturizing lotion enhances the absorption of the indomethacin through the skin and accordingly permits the drug to be employed topically for inflammation of the sunburned skin. Experimental results with the indomethacin have shown that far better results are achieved in relieving sunburned skin than other anti-inflammatory drugs, such as Motrin® and Tolectin®.
Experimental results have also shown that the use of the moisturizing lotion, marketed under the trademark Cetaphil® by Galderma Laboratories, Inc., Fort Worth, Tex. 76133, performs well in stabilizing and solubilizing the indomethacin in creating the composition for treating sunburned skin. It is theorized that Cetaphil® provides the appropriate pH and viscosity levels to effectively stabilize and solubilize the indomethacin within the moisturizing lotion. The Cetaphil® provides emollients and humectants which are clinically proven to bind water to the skin and prevent moisture loss. The ingredients of Cetaphil® include purified water, glycerin, hydrogenated polyisobutene, cetearyl alcohol (and) ceteareth-20, macadamia nut oil, dimethicone, tocopheryl acetate, stearoxytrimethylsilane (and) stearyl alcohol, panthenol, farnesol, benzyl alcohol, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, and citric acid.
To provide an effective mixture of the indomethacin and the Cetaphil®, experimentation has found that a proper mixture having substantially 100 milligrams of indomethacin per 30 cc of Cetaphil® lotion will act as an effective treatment for sunburned skin. This mixture level allows the Cetaphil® to act as a proper stabilizer and solubilizer for the indomethacin. A stronger or weaker indomethacin mixture may be created depending on the treatment. However, experimentation has shown that the above-noted mixture remains an effective mixture for the treatment of sunburned skin.
In an alternative embodiment, the present invention may provide a method and composition for the treatment of mild to moderate skin burns sustained as a result of radiation therapy or excessive heat. The composition, as previously described, includes a mixture of indomethacin and a moisturizing lotion. The composition is applied topically to the burned skin to provide highly effective relief of the symptoms associated with burned skin, including pain, itching, irritation, and local inflammation. The same composition and method, as described in the previous embodiment, are used for the treatment of skin burned through radiation therapy or excessive heat.
It should be noted that the composition and method of the present invention are to be utilized on first degree burns wherein the skin is burned by excessive heat, radiation therapy, or the sun. Such first degree burns are best described as mild or moderate. The composition and method of the present invention should not be utilized on blistered, ulcerated or infected areas.
In use, the disclosed amounts of indomethacin and Cetaphil® are mixed to create the appropriate composition. The composition is applied to the sunburned areas thereby providing almost immediate relief of the pain and discomfort associated with sunburn. The moisturizing lotion provides moisture and a cooling sensation to the sunburned skin, and the indomethacin reduces the inflammation to the skin caused by the sunburn. The composition or mixture of indomethacin and Cetaphil® should be applied to the sunburned areas one to two times daily. The same composition and method may be applied to skin that is burned by excessive heat or radiation therapy.
While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiments, but to the contrary, it is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. The scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is performed under the law.

## Claims

1. A method for treating burned skin, comprising the steps of:
providing a composition which consists essentially of an admixture of indomethacin and a moisturizing lotion, the moisturizing lotion being an oil-and-water emulsion having a pH between about 6.3 and 6.5, wherein indomethacin is maintained in stabilized and solubilized form in the moisturizing lotion wherein the moisturizing lotion consists essentially of purified water, glycerin, hydrogenated polyisobutene, cetearyl alcohol (and) ceteareth-20, macadamia nut oil, dimethicone, tocopherylacetate, stearoxytrimethylsilane (and) stearyl alcohol, panthenol, farnesol, benzyl alcohol, phenoxyethanol, acrylates/C10-30 alkyl acrylate crosspolymer, sodium hydroxide, and citric acid; and
applying said mixture topically to burned skin, the burned skin occurring by one of radiotherapy, radiation, or ultraviolet light and allowing the applied admixture to remain in contact with the skin for an interval sufficient to deliver indomethacin transdermally to the burned skin.

2. The method of claim 1 wherein said composition comprises approximately 100 milligrams of indomethacin for every 30 cc's of moisturizing lotion.

3. The method of claim 1, wherein said mixture is applied from one to two times daily to burned skin.

4. The method of claim 1, wherein said burned skin is first degree bums and said burned skin has been burned by excessive heat.