Document Detail

Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trial.
MedLine Citation:
PMID:  20704623     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Genital aphthous ulcers of Behcet's disease (BD) are painful and usually resistant to local treatments. Pimecrolimus is an ascomycin macrolactam, used in inflammatory skin diseases.
OBJECTIVE: To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers.
METHODS: Ninety patients with genital aphthous ulcers were enrolled. Only patients treated with colchicine alone were selected. All patients signed a written consent form. Patients were randomly assigned to pimecrolimus or placebo cream, applied twice daily for 1 week. The primary outcome was the healing period. Up to 7 days, it was considered as a positive result. Results were compared by chi-square test. The mean healing time was compared by analysis of variance. Analyses were done both by the 'intention-to-treat' and 'treatment-completed' methods.
RESULTS: Both groups were similar at the entry (gender, age, ulcer size, pain intensity and treatment delay). By intention-to-treat analysis, in the pimecrolimus group, 18 patients had positive and 27 negative results. In the control group, four had positive and 41 negative results. The difference was significant (chi(2) = 10.167, P = 0.001). By treatment-completed analysis, with pimecrolimus, 18 patients had positive and 22 negative results. With placebo, four had positive, and 41 negative results. The difference was significant (chi(2) = 12.574, P = 0.0004). Comparison of mean healing time in the pimecrolimus versus placebo group, demonstrated a significant acceleration both in intention-to-treat analysis (10.7 vs. 20.7 days, F = 17.466, P < 0.0001) and treatment-completed analysis (8.3 vs. 20.7 days, F = 29.289, P < 0.0001).
CONCLUSION: Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process.
Cheyda Chams-Davatchi; Behrooz Barikbin; Farhad Shahram; Abdolhadi Nadji; Maryam Moghaddassi; Maryam Yousefi; Fereydoun Davatchi
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of rheumatic diseases     Volume:  13     ISSN:  1756-185X     ISO Abbreviation:  Int J Rheum Dis     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-13     Completed Date:  2010-12-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101474930     Medline TA:  Int J Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  253-8     Citation Subset:  IM    
Behçet's Disease Unit, Rheumatology Research Center, Kargar Avenue, Tehran 14114, Iran.
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MeSH Terms
Administration, Cutaneous
Behcet Syndrome / complications*
Chi-Square Distribution
Dermatologic Agents / administration & dosage,  therapeutic use*
Double-Blind Method
Genital Diseases, Female / drug therapy*,  etiology,  pathology
Genital Diseases, Male / drug therapy*,  etiology,  pathology
Middle Aged
Placebo Effect
Stomatitis, Aphthous / drug therapy*,  etiology,  pathology
Tacrolimus / administration & dosage,  analogs & derivatives*,  therapeutic use
Time Factors
Treatment Outcome
Wound Healing / drug effects
Young Adult
Reg. No./Substance:
0/Dermatologic Agents; 0/pimecrolimus; 109581-93-3/Tacrolimus

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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