{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T21:20:55Z","timestamp":1790803255842,"version":"4.1.0"},"reference-count":28,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T00:00:00Z","timestamp":1750723200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Clascoterone is an androgen receptor inhibitor approved for the treatment of acne vulgaris in patients 12\u00a0years of age and older. Here, we report results of 5 phase 1 studies that assessed the pharmacokinetics (PK), safety, and skin irritation and sensitization potential of clascoterone cream 1% in healthy participants and patients with acne. Studies CB\u201003\u201001\/02 (EudraCT: 2007\u2010005064\u201028) and CB\u201003\u201001\/04 (n\u00a0=\u00a024 each) assessed PK in healthy participants. Study 171\u20107151\u2010203 (n\u00a0=\u00a08) assessed steady\u2010state PK in patients with acne. Studies CB\u201003\u201001\/05 (n\u00a0=\u00a036) and CB\u201003\u201001\/32 (n\u00a0=\u00a0250) assessed skin irritation and sensitization potential, respectively, in healthy participants. Systemic exposure to clascoterone was low after repeated daily application for up to 42\u00a0days of treatment. Clascoterone was excreted in urine as conjugated esters at a \u22641% fraction of the administered dose. Adverse events and local skin reactions were generally mild\/moderate and reversible. No clinically relevant changes were observed in laboratory tests and vital signs. Skin irritation and sensitization with clascoterone treatment were minimal. Phase 1 study findings supported low systemic absorption of clascoterone and a favorable safety profile after topical application of clascoterone cream 1%, with no evidence of irritation or sensitization.<\/jats:p>","DOI":"10.1002\/cpdd.1561","type":"journal-article","created":{"date-parts":[[2025,6,24]],"date-time":"2025-06-24T05:05:02Z","timestamp":1750741502000},"page":"742-753","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Pharmacokinetics, Safety, and Skin Irritation and Sensitization Potential of Clascoterone Cream in Early\u2010Phase Clinical Study Participants"],"prefix":"10.1002","volume":"14","author":[{"given":"Andrea Francesco Daniele","family":"Di Stefano","sequence":"first","affiliation":[{"name":"CROSS Research S.A. CH\u20106864 Arzo Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Milko Massimiliano","family":"Radicioni","sequence":"additional","affiliation":[{"name":"CROSS Research S.A. CH\u20106864 Arzo Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerhard","family":"Garh\u00f6fer","sequence":"additional","affiliation":[{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Cartwright","sequence":"additional","affiliation":[{"name":"Cassiopea, Inc. San Diego CA USA"},{"name":"Novan, Inc. Durham NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"M\u00fcller","sequence":"additional","affiliation":[{"name":"Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Kopeloff","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries, Inc. Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luigi","family":"Moro","sequence":"additional","affiliation":[{"name":"Cassiopea S.p.A. Lainate Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Squittieri","sequence":"additional","affiliation":[{"name":"Sun Pharmaceutical Industries, Inc. Princeton NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Mazzetti","sequence":"additional","affiliation":[{"name":"Cassiopea S.p.A. Lainate Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,24]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.13462"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13182"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.4103\/0019-5154.127667"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0625.2009.00890.x"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.14172"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/CCID.S114830"},{"issue":"5","key":"e_1_2_10_8_1","first-page":"412","article-title":"Cortexolone 17\u03b1\u2010propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro","volume":"18","author":"Rosette C","year":"2019","journal-title":"J Drugs Dermatol"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1039\/C4MD00049H"},{"key":"e_1_2_10_10_1","first-page":"165","article-title":"The fate of 1,2\u20103\u00a0h cortexolone in man","volume":"47","author":"Dehertogh R","year":"1964","journal-title":"Acta Endocrinol (Copenh)"},{"issue":"12","key":"e_1_2_10_11_1","first-page":"881","article-title":"Biological profile of cortexolone 17alpha\u2010propionate (CB\u201003\u201001), a new topical and peripherally selective androgen antagonist","volume":"54","author":"Celasco G","year":"2004","journal-title":"Arzneimittelforschung"},{"issue":"18","key":"e_1_2_10_12_1","first-page":"5073","article-title":"Inhibition of angiogenesis by suramin","volume":"52","author":"Gagliardi A","year":"1992","journal-title":"Cancer Res"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/0167-4889(95)00155-7"},{"issue":"6","key":"e_1_2_10_14_1","first-page":"563","article-title":"Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17\u2010alpha propionate, CB\u201003\u201001) topical cream, 1% in subjects with acne vulgaris: an open\u2010label phase 2a study","volume":"18","author":"Mazzetti A","year":"2019","journal-title":"J Drugs Dermatol"},{"issue":"6","key":"e_1_2_10_15_1","first-page":"570","article-title":"A phase 2b, randomized, double\u2010blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne","volume":"18","author":"Mazzetti M","year":"2019","journal-title":"J Drugs 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