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

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

doi:10.1016/j.xjidi.2021.100026

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

JID Innov. 2021 May 20;1(3):100026. doi: 10.1016/j.xjidi.2021.100026. eCollection 2021 Sep.

Authors

Takashi Nomura¹, Eriko Sumi², Gyohei Egawa¹, Saeko Nakajima¹, Eiko Toichi³, Nana Inoue³, Mami Shibuya³, Natsuko Okamoto³, Tsuyoshi Mitsuishi⁴, Ryuji Uozumi², Harue Tada², Takayuki Nakagawa⁵, Nobuhiro Kusuba⁶, Aika Okuno⁷, Chihiro Shimizuhira⁸, Makiko Ishikawa⁹, Shiro Tanaka¹⁰, Masatoshi Hagiwara¹¹, Kenji Kabashima^{1

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Affiliations

¹ Department of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
² Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan.
³ Department of Dermatology, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.
⁴ Department of Dermatology, Yachiyo Medical Center, Tokyo Women's Medical University, Yachiyo, Japan.
⁵ Department of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
⁶ Department of Dermatology, Otsu Red Cross Hospital, Otsu, Japan.
⁷ Department of Dermatology, Takatsuki Red Cross Hospital, Takatsuki, Japan.
⁸ Department of Dermatology, Rakuwakai Otowa Hospital, Kyoto, Japan.
⁹ Department of Dermatology, Kyoto Katsura Hospital, Kyoto, Japan.
¹⁰ Department of Clinical Biostatistics, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
¹¹ Department of Anatomy and Developmental Biology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
¹² Singapore Immunology Network (SIgN), Agency for Science, Technology and Research (A∗STAR), Singapore, Singapore.
¹³ Skin Research Institute of Singapore (SRIS), Agency for Science, Technology and Research (A∗STAR), Singapore, Singapore.

Abstract

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.

Keywords: CI, confidence interval; HPV, human papillomavirus.

Publication types

Clinical Trial