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, 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.


CONCLUSIONS
Thymopentin may be a safe effective adjunct to therapy in patients with severe atopic dermatitis.
Stiller
M J
MJ
Ronald O. Perelman Department of Dermatology, New York University School of Medicine, NY.
Shupack
J L
JL
Kenny
C
C
Jondreau
L
L
Cohen
D E
DE
Soter
N A
NA
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016305:Thymopentin / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D016305:Thymopentin