Safety and Efficacy of FIT039 for Verruca Vulgaris: A Placebo-Controlled, Phase I/II Randomized Controlled Trial

Safety and Efficacy of FIT039 for Verruca Vulgaris: A Placebo-Controlled, Phase I/II Randomized Controlled Trial

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Trial design: Human papillomavirus infection causes verruca vulgaris.CDK9 Undercounter Dishwashers 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 patch 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 the number of petechial lesions.Results: A total of 24 participants were randomly allocated to the FIT039 (n = 13, median age, 54 years) and placebo (n = 11, median age, 62 years) groups.Verruca vulgaris did not disappear.FIT039 decreased the dimension to 76% of the initial value on BLACK HENNA PWD 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.