CLOBETASOL PROPIONATE EMOLLIENT 0.05-PERCENT - HYPOTHALAMIC-PITUITARY-ADRENAL-AXIS SAFETY AND 4-WEEK CLINICAL EFFICACY RESULTS IN PLAQUE-TYPE PSORIASIS

Two clinical trials were conducted to evaluate the safety and antipsor iatic efficacy of a new 0.05 percent emollient formulation of clobetas ol propionate (CP), In a crossover study of hypothalamic-pituitary-adr enal (HPA)-axis effects in 12 patients with psoriasis or eczema, 1.5 g m of CP emollient, applied to lesions twice daily for seven consecutiv e days, resulted in fewer patients with serum cortisol concentrations <10 mu g/100 ml than CP cream 0.05 percent (1 vs 4); such concentratio ns were seen in two other patients during both treatment phases, A dou ble-blind, randomized, parallel-group clinical trial in patients with moderate to severe plaque-type psoriasis showed that four weeks' treat ment with CP emollient 0.43 to 0.5 gm twice daily (n=35) was significa ntly more effective than emollient vehicle (n=39) in reducing total si gns/symptoms and scaling by Day 4, erythema and skin thickening by Day 8, and pruritus by Day 15, CP emollient was rated superior to vehicle by Day 4 in physician's gross assessment ratings and by Day 15 in pat ient's self-assessment ratings, In all assessments, CP emollient conti nued to be superior to vehicle during the remainder of the treatment p eriod and two-week posttreatment period, No significant differences we re observed in tolerability or serum cortisol effects during the cours e of the study.