A randomized, double-blind, placebo-controlled, international multicenter trial was conducted, using 1.5 MIU subcutaneous interferon alpha-2a 3 times a week for 4 weeks in 170 patients (interferon, n = 125 or placebo, n = 45) with condylomata acuminata who had failed to respond to standard therapies. There was no difference in efficacy between the interferon alpha-2a and placebo treatment groups at 3 months after commencement of therapy. Although the recurrence rate at the end of 9 months' follow-up appeared lower in the interferon alpha-2a group than in the placebo group (9% versus 22%), this difference was not statistically significant. Most of the adverse events reported were typical interferon-associated mild to moderate flu-like symptoms. It is concluded that subcutaneous interferon alpha-2a, administered according to the current dosage and treatment schedule, is not effective as monotherapy in the treatment of refractory condylomata acuminata.
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