title: Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trial.
abstract: 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.
authors: Behçet's Disease Unit, Rheumatology Research Center, Kargar Avenue, Tehran 14114, Iran. fddh@davatchi.net
authors: Cheyda
authors: C
authors: Chams-Davatchi
authors: Behrooz
authors: B
authors: Barikbin
authors: Farhad
authors: F
authors: Shahram
authors: Abdolhadi
authors: A
authors: Nadji
authors: Maryam
authors: M
authors: Moghaddassi
authors: Maryam
authors: M
authors: Yousefi
authors: Fereydoun
authors: F
authors: Davatchi
mesh_terms: 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
chemical_list: D003879:Dermatologic Agents; C117268:pimecrolimus; D016559:Tacrolimus