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 production have been demonstrated in patients with atopic dermatitis. Objective : As part of a 12-week, multicenter, double-blind, placebo-controlled clinical trial...

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Veröffentlicht in:Journal of the American Academy of Dermatology 1994-04, Vol.30 (4), p.597-602
Hauptverfasser: Stiller, Matthew J., Shupack, Jerome L., Kenny, Clare, Jondreau, Lorrie, Cohen, David E., Soter, Nicholas A.
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container_end_page 602
container_issue 4
container_start_page 597
container_title Journal of the American Academy of Dermatology
container_volume 30
creator Stiller, Matthew J.
Shupack, Jerome L.
Kenny, Clare
Jondreau, Lorrie
Cohen, David E.
Soter, Nicholas A.
description Background : Multiple immunologic abnormalities such as impaired T-cell function, elevated serum IgE level, and increased interleukin 4 production have been demonstrated in patients with atopic dermatitis. Objective : As part of a 12-week, multicenter, double-blind, placebo-controlled clinical trial, we evaluated the safety and efficacy of thymopentin (Timunox) as an adjunctive treatment in patients with severe atopic dermatitis. Methods : Thirty-nine patients at least 2 years old with severe atopic dermatitis on a minimum of 20% of their cutaneous surface area were randomly selected to receive either thrice-weekly subcutaneous injections of thymopentin, 50 mg, or placebo. Use of triamcinolone 0.1% or hydrocortisone 1.0% cream and oral antihistamines were permitted during this trial. Results : After 12 weeks, thymopentin-treated patients had significantly greater improvement than those receiving placebo. No thymopentin-related adverse events occurred. Conclusion : Thymopentin may be a safe effective adjunct to therapy in patients with severe atopic dermatitis.
doi_str_mv 10.1016/S0190-9622(94)70068-0
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subjects Adolescent
Adult
Aged
Biological and medical sciences
Child
Dermatitis, Atopic - drug therapy
Double-Blind Method
Female
Humans
Injections, Subcutaneous
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Severity of Illness Index
Skin, nail, hair, dermoskeleton
Thymopentin - therapeutic use
Time Factors
Treatment Outcome
title A double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of thymopentin as an adjunctive treatment in atopic dermatitis
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