RANDOMIZED DOUBLE-BLIND TRIAL OF RECOMBINANT INTERFERON-BETA FOR CONDYLOMA ACUMINATUM

Objective: To evaluate the safety and efficacy of two intralesional do ses of recombinant human interferon-beta (r-hIFN-beta: Rebif(R), Ares Serono), given 3 times a week for 3 weeks, in the treatment of condylo ma acuminatum. Design: A randomised, double-blind, within-patient, pla cebo-controlled study. Subjects: 25 patients (24 males, 1 female) with a history of condyloma acuminatum. Twenty had failed previous treatme nt for condyloma acuminatum. In each patient, 3 distinct lesions were selected for treatment. Each selected lesion was randomly assigned to receive intralesionally one of the following: r-hIFN-beta 33,000 IU/da y, r-hIFN-beta 1 x 10(6) IU/day, or matching placebo. Setting: Institu t Alfred Fournier, Paris, France. Outcome measures: Response was evalu ated colposcopically at the end of treatment (day 22) and 5 weeks late r (month 2). Complete response (CR) was defined as disappearance of th e treated lesion. Partial response (PR) was defined as at least a 50% reduction in size, but not disappearance of the treated lesion. Result s: The higher dose of 1 x 10(6) IU achieved significantly more complet e and partial remissions than placebo, both by the end of treatment, a nd 5 weeks later. Conclusions: r-hIFN-beta appears to be safe and effe ctive when administered intralesionally to patients with condyloma acu minatum. Most of the treated patients had failed previous treatments a nd were therefore a resistant population.