A double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of thymopentin as an adjunctive treatment in atopic dermatitis.

Abstract

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.

• Authors: M J Stiller, J L Shupack, C Kenny, L Jondreau, D E Cohen, N A Soter
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 30 Issue 4 Pg. 597-602 (Apr 1994) ISSN: 0190-9622 [Print] United States
• PMID: 8157786 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Thymopentin

Topics

• Adolescent
• Adult
• Aged
• Child
• Dermatitis, Atopic (drug therapy)
• Double-Blind Method
• Female
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Severity of Illness Index
• Thymopentin (therapeutic use)
• Time Factors
• Treatment Outcome