A randomized phase II study comparing four different interferon therapies in patients with recalcitrant condylomata acuminata

Background: Interferon (IFN) alpha and IFN gamma have synergistic in vitro and in vivo effects and have each been used in the treatment of anogenital condylomata acuminata. Study Goals: To compare the efficacy and safety of regional 3 X 10⁶ U IFN alpha (Group A), 3 x 10⁶ U IFN gamma (Group B), 1.5 x 10⁶ U IFN alpha plus 1.5 x 10⁶ U IFN gamma (Group C), and 3 x 10⁶ U IFN alpha plus 1.5 x 10⁶ U IFN gamma (Group D) in the treatment of recalcitrant anogenital condylomata acuminata. Study Design: Six-week courses of regional IFNs were administered in a randomized, double-blind, multicenter study. Response was assessed as change in the total area affected by condylomata. Results: The treatments of Groups A, B, and C were similarly effective (complete response in 13.6%, 18.5%, and 16.0%, respectively). Group D had the lowest rate of complete response (3.8%), but this combination was the most effective when partial and complete responses were combined (73.0%). Conclusion: Regional IFN is a moderately effective and safe treatment in patients with recalcitrant anogenital condylomata acuminata. Combinations of IFNs alpha and gamma were not superior to IFN monotherapy.