Safety and efficacy of FIT039 for verruca vulgaris: a placebo-controlled, phase I/II randomized controlled trial

ABSTRACT Trial design Human papillomavirus infection causes verruca vulgaris. Cyclin-dependent kinase 9 inhibitor FIT039 inhibits DNA virus proliferation in animal models. We conducted a multicenter, single-blind, placebo-controlled, randomized phase I/II clinical trial evaluating the safety and efficacy of FIT039 against verruca vulgaris. Methods Target lesions were treated with liquid nitrogen once, and a FIT039- or placebo-patch was applied for 14 days. The primary endpoint was lesion disappearance. The secondary endpoints were safety and changes in dimension, cross-sectional area, and number of petechial lesions. Results Twenty-four participants were randomly allocated to the FIT039 (n = 13, median-age 54 years) and placebo groups (n = 11, median-age 62 years). Verruca vulgaris did not disappear. FIT039 decreased the dimension to 76% of the initial value on day 29, followed by an increase to 98% on day 57. Placebo showed a monotonic increase to 107% on day 57. Changes in the cross-sectional area and petechiae number were comparable between the groups. Conclusions No drug-related adverse reactions occurred. FIT039 efficacy was not determined in this study.