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

Int J Rheum Dis. 2010 Aug;13(3):253-8. doi: 10.1111/j.1756-185X.2010.01531.x.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Adolescent
  • Adult
  • Behcet Syndrome / complications*
  • Chi-Square Distribution
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Genital Diseases, Female / drug therapy*
  • Genital Diseases, Female / etiology
  • Genital Diseases, Female / pathology
  • Genital Diseases, Male / drug therapy*
  • Genital Diseases, Male / etiology
  • Genital Diseases, Male / pathology
  • Humans
  • Iran
  • Male
  • Middle Aged
  • Placebo Effect
  • Stomatitis, Aphthous / drug therapy*
  • Stomatitis, Aphthous / etiology
  • Stomatitis, Aphthous / pathology
  • Tacrolimus / administration & dosage
  • Tacrolimus / analogs & derivatives*
  • Tacrolimus / therapeutic use
  • Time Factors
  • Treatment Outcome
  • Wound Healing / drug effects
  • Young Adult


  • Dermatologic Agents
  • pimecrolimus
  • Tacrolimus