JIN-BON HONGWu, Po-YuanPo-YuanWuQin, AlbertAlbertQinYI-WEN HUANGTseng, Kuan-ChiaoKuan-ChiaoTsengLai, Ching-YuChing-YuLaiChan, Wing-KaiWing-KaiChanFang, JaneJaneFangCutler, David LDavid LCutlerTSEN-FANG TSAI2023-06-272023-06-272022-10-111999-4923https://scholars.lib.ntu.edu.tw/handle/123456789/633140Plaque-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.enKX01clinical trialpsoriasistirbanibulinjournal article10.3390/pharmaceutics14102159362975942-s2.0-85140952384https://api.elsevier.com/content/abstract/scopus_id/85140952384