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.
Clobetasol propionate is a man-made corticosteroid that is used on the skin (topically). It is available as foam, shampoo, cream, gel, lotion, ointment, solution, and spray. It is similar to alclometasone (Aclovate), hydrocortisone valerate (Westcort), halobetasol ( Ultravate ) and several others. Topical clobetasol is used to treat certain scalp and skin conditions such as psoriasis , rashes, and dermatitis . Corticosteroids have potent anti-inflammatory actions and also suppress the immune response. Clobetasol is a very potent topical corticosteroid and should only be used for a short period of time. Long term use of topical clobetasol propionate can cause serious systemic side effects and should be avoided.
The mean age of subjects was 54 +/- years (range, 15-86), and the average duration of treatment prior to clobetasol use was 6 +/- years (range, -29). Twenty-seven subjects did not complete the study or were lost to follow-up. The average subject had tried treatment modalities (range, 1-13). The most common symptoms were pruritus (98%) and irritation (61%), with complaints of burning and dyspareunia. Most subjects (76%) had labial involvement, with concomitant involvement of the clitoris (70%), perineum (68%) and perianus (32%). The majority (88%) of subjects had a primary lesion of white and crinkled tissue. With clobetasol, 77% of subjects had complete remission of symptoms, 18% had partial remission and 5% reported no change. A change in clinical appearance was noted for the complete-remission (32%) and partial-remission groups (46%). Twenty-two percent revealed no change.