https://scholars.lib.ntu.edu.tw/handle/123456789/633140
標題: | Topical Tirbanibulin, a Dual Src Kinase and Tubulin Polymerization Inhibitor, for the Treatment of Plaque-Type Psoriasis: Phase I Results | 作者: | JIN-BON HONG Wu, Po-Yuan Qin, Albert Huang, Yi-Wen Tseng, Kuan-Chiao Lai, Ching-Yu Chan, Wing-Kai Fang, Jane Cutler, David L TSEN-FANG TSAI |
關鍵字: | KX01;clinical trial;psoriasis;tirbanibulin | 公開日期: | 11-十月-2022 | 卷: | 14 | 期: | 10 | 來源出版物: | Pharmaceutics | 摘要: | Plaque-type psoriasis is a common skin disorder. Tirbanibulin (KX01) is a new Src kinase inhibitor with potent antiproliferative activity against keratinocytes and has been approved for treatment of actinic keratosis. This Phase I study investigates the safety and activity of KX01 ointment in patients with plaque-type psoriasis. We recruited 28 patients from two medical centers in Taiwan. This study was performed in four stages. Double-blind treatments were randomized in stages I (KX01 0.01% + placebo, two rounds of two-week treatment) and II (KX01 0.1% + placebo, four weeks) and open-labelled in stages III (KX01 1%, five days) and IV (KX01 1%, five days weekly for four weeks). The safety, tolerability, KX01 concentration, target area score, physician global assessment, and disease relapse were determined. Most treatment-emergent adverse events were mild-to-moderate application site reactions. Three (50.0%) subjects from the stage IV group showed ≥50% reduction in the target area score (TAS50), while two subjects (33.3%) showed a clinically meaningful improvement in the physician global assessment score. KX01 0.01%, 0.1%, and 1% were safe and well-tolerated. KX01 1% at four weeks showed a promising activity for the treatment of plaque-type psoriasis. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/633140 | ISSN: | 1999-4923 | DOI: | 10.3390/pharmaceutics14102159 |
顯示於: | 醫學院附設醫院 (臺大醫院) |
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