Method and Topical Composition for the Treatment of Rosacea and Skin Erythema Using Selenium Sulfide

[0001] None.

[0002] None.

[0003] None.

[0004] 1. Field of the Invention

[0005] This invention relates to the treatment of Rosacea and skin erythema, in general, and to a method utilizing a topical composition employing selenium sulfide of different concentrations depending on the severity and extent of user symptoms, in particular.

[0006] 2. Description of the Related Art

[0007] Rosacea is a very common red, acne-like benign skin condition that affects approximately 45 million people worldwide. Its main symptoms include red or pink facial skin, small dilated blood vessels, small red bumps sometimes containing pus, cysts, and pink or irritated eyes. Characteristically involving the central region of the face (mainly the forehead, the cheeks, the chin, and the lower half of the nose), Rosacea is considered a chronic, long-term incurable skin condition with periodic ups and downs. Tending to occur more frequently in women, but more severely in men, Rosacea strikes both at potentially all ages. Unfortunately, emotional factors such stress, fear, anxiety and embarrassment have been determined to aggravate the condition.

[0008] While lacking evidence that Rosacea can be spread by contact with the skin, the sharing of towels, or through inhalation, left untreated, the condition tends to worsen over time. Often being mistaken for acne, an allergic reaction, or other skin problems, its signs and symptoms may flair up for a period of weeks to months, and then diminish before flaring up again. Often aggravated by flushing, the redness in Rosacea may cause small blood vessels in the face to enlarge permanently and become more visible through the skin, appearing like tiny red lines. Continual or repeated episodes of flushing and blushing may promote inflammation, causing small red bumps often resembling teenage acne.

[0009] While not considered contagious or infectious—and even not necessarily requiring treatment if the individual is not bothered by the condition—many treatment choices are available depending on the severity and extent of symptoms. Antibacterial washes, topical medications, oral antibiotics, lasers, pulsed-light therapies, photodynamic therapy, and isotretinoin have oftentimes been utilized—with varying degrees of success and commensurate costs. Combination uses of them are not uncommon, with some being utilized alternatingly in the morning and at night, and others, such as with topical medications, more than once or twice a day. With metronidazole topical antibiotic medication (Rosadan®) and Azelaic Acid (Finacea®) costing in prescription amounts by dermatologists of $300.00 and more, it would be advantageous to have a simple pharmaceutical composition to effectively overcome the flushing and redness in the case of Rosacea, which is not yet achievable by the use of available treatments at a less expensive cost.

[0010] As will be understood, the same holds true for skin erythema, in general.

[0011] It is an object of the present invention, therefore, to provide an effective composition for the treatment of Rosacea.

[0012] It is an object of the present invention, also, to provide such a composition which is both easy to apply, and which can be obtained at a more affordable price.

[0013] It is an additional object of the invention to provide such a composition which for mild instances of Rosacea may be obtained over-the-counter, without the need for prescription.

[0014] It is a further object of the invention to provide a composition of greater concentration for a more resistant condition of Rosacea, obtainable by prescription.

[0015] It is yet a further object of the present invention to provide such a composition for treating other conditions of the skin characterized by redness (i.e. skin erythema), and either as a gel, cream or lotion.

[0016] As will become clear from the following description, the objects of the present invention are achieved through the employment of selenium sulfide as an active ingredient in the method of treatment of Rosacea. As will be understood by those skilled in the art, having the chemical formula SS_e, and also available as selenium disulfide S_eS₂, and selenium hexasulfide S_eS₆, selenium sulfide is an antifungal agent often used in shampoos for the treatment of dandruff and seborrheic dermatitis. In such respects, selenium sulfide has been shown to be one in a class of anti-infectives that slow the growth of yeast which can lead to itching and flaking of the scalp. In a tested embodiment of the invention, selenium sulfide is combined with a cocoa butter moisturizer carrier in the treatment of the Rosacea. In a preferred embodiment, the selenium sulfide is employed as the sole active ingredient in the treatment.

[0017] Selenium sulfide is currently employed in a concentration of 1% in such dandruff shampoos as Selsun Blue®, Exsel® lotion shampoo, Glo-Sel®, and Head & Shoulders® Intensive Treatment. It is used with warm water to be massaged as a lather into the hair and scalp, being typically used once per clay, or at least two times per week as directed by the user's physician.

[0018] In accordance with the present invention, and through clinical type observations, it has been determined that a topical application utilizing selenium sulfide is effective in significantly reducing the redness, flushing and inflammation associated with the chronic, incurable adult acne-like skin condition of Rosacea—and with skin erythema, in general.

[0019] The composition of the invention may comprise all pharmaceutical forms for administration including solutions, gels, lotions and creams—as well as ointments, foams, emulsions, micro-emulsions, milks, serums, aerosols, sprays, dispersions, micro-capsules and micro-particles thereof. Acceptable carriers for the selenium sulfide are those suitable for topical applications for the skin, will not cause any safety or toxicity concerns, and will be compatible with the selenium sulfide. One such carrier employed successfully with the selenium sulfide has been found to be cocoa butter, an edible vegetable fat extracted from the cocoa bean. A ratio of about 3 parts cocoa butter to 1 part selenium sulfide provided almost optimum results in effectiveness to decrease the erythema resulting from Rosacea. Also utilizable as soaps and cleansing bars, a 1% concentration of selenium sulfide ingredient has been approved by the FDA for cover-the-counter sales—and thus more readily obtainable, and at a lesser cost than other prescription medications used to treat these skin conditions. Effective in most instances of Rosacea, more resistant situations can be resolved by increasing the selenium sulfide concentrations to 2%, 3% or 4% levels; obtainable in the later percentages, however, only by way of dermatological prescription. Whether supplemented with known bases such as excipients, binders, lubricants and disintegrants—or with selected oily materials or emulsifying agents—the treatment with this composition has been noted to be effective in a simple one step application process. In fact, analysis has indicated that the composition of the invention with its use of selenium sulfide can provide similar benefits for treating other skin complaints, conditions and afflictions—as with antibacterial agents, anti-acne agents, antiparasitic agents, antifungal agents, anti-inflammatory agents, and others. As such, with the selenium sulfide, such other discreet erythema as acne and sunburn can be effectively reduced as well.

[0020] In clinical type observations, the redness, small dilated blood vessels and small red bumps characterizing Rosacea have been observed to be decreased in a manner akin to the controlling of those spots found on the skin which appear from conditions known as Tinea Capitis (a fungal form of ringworm most commonly affecting children, causing itchy scalp and loss of hair in the affected areas) and Tinea Versicolor (a fungal itchy and scaly spotting lighter than the surrounding skin). There, fungi germs living on the tissue of the outer skin layers tend to spread easily, but whose growth is kept under reasonable control through the topical application of selenium sulfide. Treatment of dermatophyte fungal infections also with oral antifungal agents in more pronounced cases have been known to recognize the acceptance of selenium sulfide as a preventative—and in accordance with the teachings of the present invention, have been found to extend further into the area of controlling the effects of Rosacea.

[0021] In usage, the composition of the invention is to be administered topically by a vehicle or carrier medium compatible with application to the skin. A useful regimen would be to a) mix 1% selenium sulfide with 3 ml of cocoa butter cream; b) apply it to the area of concern; and c) leave the blended mixture for 2-3 minutes at the area of application. The composition will be seen to be highly effective in reducing the flushness and redness caused by Rosacea. In a preferred embodiment of the invention, the selenium sulfide is employed as the sole active agent in the composition.

[0022] While there have been described what are considered to be preferred embodiments of the present invention, it will be readily appreciated by those skilled in the art that modifications can be made without departing from the scope of the teachings herein. For at least such reason, therefore, resort should be had to the claims appended hereto for a true understanding of the scope of the invention.