CLOBETASOL PROPIONATE EMOLLIENT 0.05-PERCENT IN THE TREATMENT OF ATOPIC-DERMATITIS

A 4-week, double-blind, randomized clinical trial, comparing the effic acy and safety of clobetasol propionate emollient cream 0.05% and its vehicle, was conducted at four private dermatology clinics in 81 non-h ospitalized patients (greater than or equal to 12 years old) with mode rate-to-severe atopic dermatitis covering 2% or more of their body sur face. All patients had at least one lesion 2 cm or more in diameter. T hree signs/symptoms of target lesions (erythema, pruritus, and indurat ion/papulation) were scored by investigators on a scale of 0-3 (in 0.5 -point increments; 0 = absent, 1 = mild, 2 = moderate, and 3 = severe) ; the total of the three scores had to be greater than or equal to 6 f or patients to qualify for study entry. Patients were excluded if they were immunocompromised, pregnant, or nursing; had skin atrophy, telan giectasia or striae in skin areas to be treated; or had received topic al treatments for atopic dermatitis within 1 week prestudy, intramuscu lar triamcinolone within 6 weeks prestudy, or long-term systemic corti costeroid usage within 6 months prestudy. Patients were randomized in a 1 : 1 ratio to receive either clobetasol propionate emollient 0.05% twice daily (n = 41), or the emollient vehicle twice daily (n = 40), f or 4 weeks. A fingertip unit, equaling approximately 0.5 g in males an d 0.43 g in females (enough to cover approximately 2% of the body), wa s used to measure and apply a thin film of study drug to the affected areas. The efficacy was evaluated by investigators and patients on day s 4, 8, 15, and 29 after initiation of therapy, and 2 weeks after the end of treatment (day 43). Investigators performed a physician's gross assessment based on the percentage improvement of the target lesion. They also rated changes from baseline in mean severity scores for six individual signs/symptoms (erythema, pruritus, induration/papulation, lichenification, erosion/oozing/crusting, and scaling/dryness) and for total signs/symptoms according to the severity scoring system describ ed above. Patients rated their response to treatment as excellent, goo d, fair, poor, or worse. Laboratory assessments were made on days 15, 29, and (if necessary) day 43.