Pimecrolimus versus Placebo in Genital Aphthous Ulcers of Behcet’s Disease, Randomized Double-Blind Controlled Trial


Abstract: 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 find if Pimecrolimus could 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 one 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 ANOVA. Analyses were done both by “Intention to Treat” and “Treatment-Completed” method. Results: Both groups were similar in the entry (gender, age, ulcers size, pain intensity, and treatment delay). By intention to treat analysis, in Pimecrolimus group, 18 patients had positive and 27 negative results. In control group, 4 had positive and 41 negative results. The difference was significant (Chi2=10.167, p=0.001). By treatment-completed analysis, with Pimecrolimus, 18 had positive and 22 patients negative results. With placebo, 4 had positive, and 41 negative results. The difference was significant (Chi2=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 versus 20.7 days, F=17.466, p<0.0001) and treatment-completed analysis (8.3 versus 20.7 days, F=29.289, p<0.0001). Conclusion: Pimecrolimus is safe and efficient in BD genital ulcer, by accelerating the healing process.