Self-treatment using a 0.5% podophyllotoxin cream of external genital condylomata acuminata in women. A placebo-controlled, double-blind study.

In a double-blind, placebo-controlled study, self-treatment with a 0.5% podophyllotoxin cream was evaluated among 60 women afflicted solely with outer vulvoanal warts; 12 women received treatment with placebo cream and 48 women with active substance, administered twice daily in 3-day cycles once weekly for up to 3 weeks. Patients who were not completely cured after three cycles were classified as treatment failures. Four patients treated with podophyllotoxin cream were excluded: two were considered drop-outs, another patient was concurrently afflicted with intraanal warts, and a fourth patient refused further therapy with the cream due to the severity of local side effects occurring from the first course of therapy. Of the remaining 44 patients treated with active substance, the primary cure rates were 43%, 66%, and 91% after 1, 2, and 3 treatment cycles, respectively. Within a 3-month follow-up period, 6 (14%) patients who were originally considered cured exhibited some degree of either "recurrence" or "reoccurrence". Thus, a complete and permanent cure from podophyllotoxin cream occurred in 38 out of 44 patients (77%). Placebo lacked therapeutic influence. A slight-to-moderate tenderness, pain, burning, or all of the above in the treated areas was noted by more than 60% of the women who were treated with the podophyllotoxin cream.

RCT Entities:   Population Interventions Outcomes