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Safety and Efficacy of FIT039 for Verruca Vulgaris: A Placebo-Controlled, Phase I/II Randomized Controlled Trial
oleh: Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Nana Inoue, Mami Shibuya, Natsuko Okamoto, Tsuyoshi Mitsuishi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Nobuhiro Kusuba, Aika Okuno, Chihiro Shimizuhira, Makiko Ishikawa, Shiro Tanaka, Masatoshi Hagiwara, Kenji Kabashima
Format: | Article |
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Diterbitkan: | Elsevier 2021-09-01 |
Deskripsi
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.