Another well-controlled clinical study evaluated 279 subjects with mild to moderate plaque-type psoriasis (mean Body Surface Area at baseline was % with a range from 1% to 20%) of non-scalp regions. Subjects were treated twice daily for 2 weeks with OLUX (clobetasol propionate) Foam or Vehicle foam. The face and intertriginous areas were excluded from treatment. The efficacy of OLUX (clobetasol propionate) Foam in treating non-scalp psoriasis at the end of 2 weeks' treatment was superior to that of Vehicle foam. See Table 2 below.
In a 90-day repeat-dose toxicity study in rats, topical administration of clobetasol propionate foam at dose concentrations from % to % or from to mg/kg/day of clobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organs systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk for carcinogenesis.
Fluticasone propionate is a synthetic (man-made) corticosteroid that is used on the skin (topically). The naturally-occurring corticosteroid is cortisol or hydrocortisone produced by the adrenal gland. Corticosteroids have potent anti-inflammatory actions and also suppress the immune response. Similar drugs include betamethasone dipropionate (Diprolene), clobetasol propionate (Temovate), halobetasol propionate (Ultravate), betamethasone dipropionate (Diprosone), desoximetasone (Topicort), halcinonide (Halog), amcinonide (Cyclocort), triamcinolone acetonide (Kenalog), fluocinolone acetonide (Synalar), hydrocortisone butyrate (Locoid), hydrocortisone valerate (Westcort), and mometasone furoate (Elocon). The FDA approved topical fluticasone propionate in December, 1990.