Related Experiment Video
Updated: Oct 10, 2025

Author Spotlight: Dermatopathology and the Treatment of Sexually Transmitted Diseases
Published on: November 8, 2024
Safety and Efficacy of FIT039 for Verruca Vulgaris: A Placebo-Controlled, Phase I/II Randomized Controlled Trial
Takashi Nomura1, Eriko Sumi2, Gyohei Egawa1
1Department of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Trial Design:
Human papillomavirus infection causes verruca vulgaris. CDK9 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 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.
More Related Videos
Related Concept Videos
Clinical Trials: Overview
Clinical Trials
There are four phases in a clinical trial. A phase one...
Bioequivalence studies: Biowaivers
Varicose Veins II: Diagnostic Studies and Interprofessional Care
Bioavailability Study Design: Healthy Subjects Versus Patients

