Dermatoses is a disease of the skin. One form of dermatoses is rosacea. Rosacea is an acne form condition primarily affecting the areas of the nose, cheeks, and forehead of adults. The condition is characterized by erythema, papules, rhinophyma, and telagiectases. The cause of rosacea is unknown, however, dietary influence, gastrointestinal disturbances, psychologic or hormonal imbalance, sebaceous gland abnormalities, and infection have been considered but not validated. Other theories range from solar-induced dermal connective tissue damage, with resultant vascular distension to humorally mediated active vasodilatory changes. A causative role has also been suggested for the hair follicle mite, Demodex, C. E. Bonnard, et al., The Demodex Mite Population, J. Amer. Acad. Dermatology, Vol. 28, No. 3, pp. 443-447, March 1993.
Dermatoses or other skin disorders refers generally to any condition, infection, disease or disorder which afflicts the skin of a patient. Sodium sulfacetamide with and without sulfur has been utilized for many years to treat acne. A nominal treatment concentration for sodium sulfacetamide is 10% and for sulfur is 5%. Sulfacet R® by Dermik Laboratories is a marketed example of such products.
Sulfur alone has been used to treat skin diseases, such as acne, for over 100 years. Sulfur products have been used at levels up to 10% to treat acne. Sulfur has also been combined with resorcinol to improve its performance.
The use of UV absorbers to counteract the sensitizing effects of some dermatological therapeutics has been described in the art. For example, the use of UV absorbers in combination with erythromycin for the treatment of acne is described in U.S. Pat. No. 5,017,366.
A. P. Kelly (Principles and Practice of Dermatology, Sams and Lynch editors, 1990, p. 789) indicates that avoidance of sun exposure is a mechanism to be explored in the management of the skin flushing often seen with rosacea. J. K. Wilkins stated (Id, p. 495) that “the degree to which reddening occurs results not only from the intensity of the flushing reaction, but also from the pigmentation of the subject and the visibility of the vessels, which may be enhanced in a sun-damaged dystrophic dermis.”
Many skin disorders are treated with a single course of therapy on the premise that the etiology and presented symptoms are the result of a single cause. Unfortunately, many diseases, especially skin diseases, are complicated in that the symptoms may be the result of changes in internal, external, or a combination of both environments. As a result, conventional single agent therapies have been shown not to yield the desired clinical results demonstrated, for example, as cosmetic improvement (appearance), elimination of pathogenic organisms, reduction of swelling, etc. Skin disorders where two or more conditions have been identified include acne and rosacea.
Antibacterial compositions for dermatological treatment must remain stable for long periods of time (useful shelf life), not lose its potency (a known characteristic of antibiotics under certain conditions), not form insoluble substances or complexes because of the combining sulfacetamide and other active ingredients, and also not be especially irritating to the skin.
Sunscreens are designed to protect against sunburn caused by UVB rays and generally provide little protection against UVA rays. UVA rays are linked to aging and generally have a depressing effect on the immune system and therefore may lead to other dermatological problems such as rosacea.
Missing in the art is a convenient means to ensure patient compliance with topical administration of a sulfacetamide and a sunscreen. At present, there is no commercially available product containing both a sulfacetamide and a sunscreen.
There has also been great difficulty in the art in preparing a topical composition that can effectively be administered for treating skin dermatoses that contains both sulfacetamide and a sunscreen. Such compositions for dermatological treatment of skin dermatoses must remain stable for long periods of time, not lose their potency, not form insoluble substances or complexes because of the combining sulfacetamide and other active ingredients, and must minimize irritation to the skin. There is a lack of such compositions in the art for treatment of skin dermatoses.
Accordingly, there remains a need in the art for a stable topical composition having effectiveness in treating skin dermatoses than the presently known compositions.
USPTO Backgrounds
USPTO Backgrounds