Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trial.
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).


CONCLUSIONS
Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process.
Chams-Davatchi
Cheyda
C
Behçet's Disease Unit, Rheumatology Research Center, Kargar Avenue, Tehran 14114, Iran. fddh@davatchi.net
Barikbin
Behrooz
B
Shahram
Farhad
F
Nadji
Abdolhadi
A
Moghaddassi
Maryam
M
Yousefi
Maryam
M
Davatchi
Fereydoun
F
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D001528:Behcet Syndrome / Q000150:complications*; D016009:Chi-Square Distribution; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005831:Genital Diseases, Female / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D005832:Genital Diseases, Male / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D006801:Humans; D007492:Iran; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D013281:Stomatitis, Aphthous / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D016559:Tacrolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects; D055815:Young Adult
D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus