Médecine

Paramédical

Autres domaines


S'abonner

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

Doi : 10.1016/j.jaad.2020.04.087 
Lawrence Eichenfield, MD a, Adelaide Hebert, MD b, Linda Stein Gold, MD c, Martina Cartwright, PhD d, Enrico Fragasso, MS e, Luigi Moro, PhD e, Alessandro Mazzetti, MD e,
a Division of Pediatric and Adolescent Dermatology, University of California, San Diego, and Rady Children's Hospital, San Diego, California 
b Department of Dermatology, The University of Texas Health Science Center McGovern Medical School, Houston 
c Department of Dermatology, The Henry Ford Medical Center, Detroit 
d Cassiopea Inc, San Diego 
e Cassiopea S.p.A., Lainate, Italy 

Correspondence to: Alessandro Mazzetti, MD, Cassiopea S.p.A., Via Cristoforo Colombo 1, 20020 Lainate, Italy.Cassiopea S.p.A.Via Cristoforo Colombo 1Lainate20020Italy

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.

Le texte complet de cet article est disponible en PDF.

Key words : acne, androgen receptor inhibitor, antiandrogen, clascoterone, cream, long-term safety, topical

Abbreviations used : AE, IGA, ITT, LSR, PP, TEAE


Plan


 Funding sources: This study was funded by Cassiopea S.p.A., Italy.
 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.
 IRB approval status: Reviewed and approved by individual study sites.
 Reprint requests: Martina Cartwright, PhD, mcartwright@cassiopea.com.
 Reprints are not available from the authors.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

  • Contenu

Vol 83 - N° 2

P. 477-485 - août 2020 Retour au numéro
Article précédent Article précédent
  • Surgery versus combined treatment with curettage and imiquimod for nodular basal cell carcinoma: One-year results of a noninferiority, randomized, controlled trial
  • Kelly A.E. Sinx, Patty J. Nelemans, Nicole W.J. Kelleners-Smeets, Veronique J.L. Winnepenninckx, Aimee H.M.M. Arits, Klara Mosterd
| Article suivant Article suivant
  • Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries
  • Esther E. Freeman, Devon E. McMahon, Jules B. Lipoff, Misha Rosenbach, Carrie Kovarik, Junko Takeshita, Lars E. French, Bruce H. Thiers, George J. Hruza, Lindy P. Fox, American Academy of Dermatology Ad Hoc Task Force on COVID-19

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

Mon compte


Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.