Pidotimod in the management of vulvar papillomatosis: double-blind clinical trial versus placebo.

To investigate whether the immune system improvement induced by pidotimod increases the rate of spontaneous disappearance of vulvar papillomatous lesions, a multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Forty-nine patients (23 in the pidotimod group and 26 in the placebo group) with first diagnosis of vulvar papillomatosis as shown by clinical and histological findings underwent 90-day treatment with oral 800-mg pidotimod once a day or identical placebo. The main outcome measure was the difference between vulvar papillomatous infected area before and after treatment judged by the following: complete regression (complete disappearance of all papillomatous lesions); partial regression (a decrease of at least 75% of the infected area); no response (a decrease of less than 75% of the infected area or new viral lesions not present at baseline). Forty patients completed the trial according to the study protocol and were entered in the "per protocol" analysis of efficacy. Complete regression was observed in 12 of 18 patients (66.7%) receiving pidotimod compared with 7 of 22 patients (31.8%) receiving placebo. The total infected surface area at the end of treatment was 10.1 +/- 18.5 mm2 (mean +/- SD) in the pidotimod arm and 198.3 +/- 399.2 mm2 in the placebo arm (p < 0.05 between treatment). Notwithstanding the fact that better results were obtained in the pidotimod group, more data are needed to confirm our encouraging results.