A DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL-TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THYMOPENTIN AS AN ADJUNCTIVE TREATMENT IN ATOPIC-DERMATITIS

Background: Multiple immunologic abnormalities such as impaired T-cell function, elevated serum IgE level, and increased interleukin 4 produ ction have been demonstrated in patients with atopic dermatitis. Objec tive: As part of a 12-week, multicenter, double-blind, placebo-control led clinical trial, we evaluated the safety and efficacy of thymopenti n (Timunox) as an adjunctive treatment in patients with severe atopic dermatitis. Methods: Thirty-nine patients at least 2 years old with se vere atopic dermatitis on a minimum of 20% of their cutaneous surface area were randomly selected to receive either thrice-weekly subcutaneo us injections of thymopentin, 50 mg, or placebo. Use of triamcinolone 0.1% or hydrocortisone 1.0% cream and oral antihistamines were permitt ed during this trial. Results: After 12 weeks, thymopentin-treated pat ients had significantly greater improvement than those receiving place bo. No thymopentin-related adverse events occurred. Conclusion: Thymop entin may be a safe effective adjunct to therapy in patients with seve re atopic dermatitis.