{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T22:58:37Z","timestamp":1780441117492,"version":"3.54.1"},"reference-count":36,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T00:00:00Z","timestamp":1665446400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"PharmaEssentia Corp."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>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 \u226550% 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.<\/jats:p>","DOI":"10.3390\/pharmaceutics14102159","type":"journal-article","created":{"date-parts":[[2022,10,11]],"date-time":"2022-10-11T06:13:27Z","timestamp":1665468807000},"page":"2159","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Topical Tirbanibulin, a Dual Src Kinase and Tubulin Polymerization Inhibitor, for the Treatment of Plaque-Type Psoriasis: Phase I Results"],"prefix":"10.3390","volume":"14","author":[{"given":"Jin-Bon","family":"Hong","sequence":"first","affiliation":[{"name":"Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei 100, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Po-Yuan","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Dermatology, China Medical University Hospital, Taichung 40402, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7610-084X","authenticated-orcid":false,"given":"Albert","family":"Qin","sequence":"additional","affiliation":[{"name":"PharmaEssentia Corporation, 13F, No. 3, Park Street, NanKang District, Taipei 115, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5196-7030","authenticated-orcid":false,"given":"Yi-Wen","family":"Huang","sequence":"additional","affiliation":[{"name":"PharmaEssentia Corporation, 13F, No. 3, Park Street, NanKang District, Taipei 115, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1324-0911","authenticated-orcid":false,"given":"Kuan-Chiao","family":"Tseng","sequence":"additional","affiliation":[{"name":"PharmaEssentia Corporation, 13F, No. 3, Park Street, NanKang District, Taipei 115, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ching-Yu","family":"Lai","sequence":"additional","affiliation":[{"name":"PharmaEssentia Corporation, 13F, No. 3, Park Street, NanKang District, Taipei 115, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wing-Kai","family":"Chan","sequence":"additional","affiliation":[{"name":"Athenex, Inc., Conventus, 1001 Main Street, Suite 600, Buffalo, NY 14203, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Fang","sequence":"additional","affiliation":[{"name":"Athenex, Inc., Conventus, 1001 Main Street, Suite 600, Buffalo, NY 14203, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L.","family":"Cutler","sequence":"additional","affiliation":[{"name":"Athenex, Inc., Conventus, 1001 Main Street, Suite 600, Buffalo, NY 14203, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1498-1474","authenticated-orcid":false,"given":"Tsen-Fang","family":"Tsai","sequence":"additional","affiliation":[{"name":"Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei 100, Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,10,11]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1111\/jdv.13854","article-title":"A systematic review of worldwide epidemiology of psoriasis","volume":"31","author":"Michalek","year":"2017","journal-title":"J. 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