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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 …