Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris - 23/07/20
Abstract |
Background |
Androgens foster acnegenic pathways.
Objective |
To assess the long-term safety of an androgen receptor inhibitor, clascoterone cream, 1%, in patients who participated in phase 3 studies.
Methods |
Clascoterone cream was applied twice daily for up to 9 months to the face or trunk, or both. Treatment-emergent adverse events (TEAEs) and local skin reactions were evaluated at months 1, 3, 6, and 9, and at any unscheduled visit(s). The statistical analysis was performed using SAS Windows 9.3 software (SAS Institute Inc, Cary, NC).
Results |
The study screened and enrolled 609 individuals (n = 317 clascoterone, n = 292 vehicle from original studies), and 347 completed the study (n = 179 clascoterone, n = 168 vehicle). Overall, 110 patients (18.1%) experienced 191 TEAEs. The most frequently reported TEAE was nasopharyngitis (n = 20). A total of 19 test article–related TEAEs occurred in 14 patients; of these, 9 experienced 9 TEAEs leading to discontinuation. There were 7 serious TEAEs in 6 individuals, but none were treatment related. One serious TEAE led to study discontinuation. Overall, treatment-emergent local skin reactions occurred in 18.1% (110 of 607). The most frequent local skin reactions on the face and trunk were erythema, scaling/dryness, and pruritus, and most were trace/minimal or mild in severity.
Limitations |
Long-term efficacy was not a primary end point.
Conclusion |
A low frequency of TEAEs over 9 months of clascoterone treatment was observed.
Il testo completo di questo articolo è disponibile in PDF.Key words : acne, androgen receptor inhibitor, antiandrogen, clascoterone, cream, long-term safety, topical
Abbreviations used : AE, IGA, ITT, LSR, PP, TEAE
Mappa
| Funding sources: This study was funded by Cassiopea S.p.A., Italy. |
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| Conflicts of interest: Drs Eichenfield, Hebert, and Stein Gold served as study investigators and as consultants to Cassiopea and have received honoraria and fees. Dr Eichenfield has served as an investigator, advisor, or consultant for Allergan, Almirall, Foamix Pharmaceuticals, Galderma Laboratories, L'Oréal, and Ortho Dermatologics. Dr Hebert received research funds from Cassiopea and Novan that were paid to the UTHealth McGovern Medical School-Houston and is an advisor or consultant for Allergan, Almirall, Galderma, and Ortho Dermatologics. Dr Stein Gold has served as an advisor and investigator for Foamix Pharmaceuticals, GlaxoSmithKline, LEO Pharma, and Valeant, as an investigator for Janssen, and as an advisor for Novartis. Dr Cartwright is an employee of Cassiopea Inc and holds stock options. Mr Fragasso and Drs Moro and Mazzetti are employees of Cassiopea S.p.A. and hold stock options. |
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| IRB approval status: Reviewed and approved by individual study sites. |
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| Reprint requests: Martina Cartwright, PhD, mcartwright@cassiopea.com. |
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| Reprints are not available from the authors. |
Vol 83 - N° 2
P. 477-485 - agosto 2020 Ritorno al numero
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