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.

An earlier study by this group failed to demonstrate significant therapeutic effect of 4 weeks of systemic recombinant interferon (IFN)-alpha 2 monotherapy on anogenital condylomata acuminatum. The present study was undertaken to determine if 3 MIU of IFN given three times weekly for 4 consecutive weeks and starting immediately after CO2 laser ablation of all visible warts would be effective. In a multicenter placebo-controlled randomized double-blinded study of 130 evaluatable patients followed for 36 weeks after treatment, no beneficial effects were noted in terms of complete response (24 placebo vs. 23 IFN patients) and recurrences (38 placebo vs. 46 IFN patients). None of the pretreatment and demographic characteristics affected outcome with statistically significant differences. CO2 laser ablation combined with systemic recombinant IFN-alpha 2 was ineffective in this study as treatment of anogenital condylomata.

Objectives - to compare the response to treatment and recurrence rate of condylomata accuminata using subcutaneous injection of interferon alfa 2a 1.5 million units three times weekly for four weeks, or podophyllin resin 25% applied to lesions twice weekly for up to six weeks.Design - Randomised open study.Setting - Multicentre European study in genitourinary medicine, dermatovenereology, and gynaecology departments.Patients - 87 males and 67 females with condylomata acuminata for less than six months and no history of previous treatment.Main outcome measures - Complete clearance of lesions and evidence of recurrence at three months and nine months after treatment commenced.Results - A complete response was achieved at three months in 15 of 64 (23%) in the interferon treated group, and 31 of 69 (45%) in the podophyllin treated group (p = 0.003). At nine months 10 of 13 patients in the interferon group and 22 of 30 patients in the podophyllin group remained completely clear of lesions.Conclusions - At the dose regimen used interferon alfa 2a monotherapy was not as effective a therapy as the standard therapy of podophyllin 25% application.