Error: 429: HTTP/2 429 Error: 429: HTTP/2 429 Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris - JDDonline - Journal of Drugs in Dermatology

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris

August 2023 | Volume 22 | Issue 8 | 810 | Copyright © August 2023


Published online July 31, 2023

doi:10.36849/JDD.7592

Lawrence F. Eichenfield MDa, Adelaide A. Hebert MDb, Linda Stein Gold MDc, Martina Cartwright PhDd, Luigi Moro PhDe, Jenny Han MSf, Nicholas Squittieri MDg, Alessandro Mazzetti MDe

aUniversity of California San Diego School of Medicine, La Jolla, CA; Rady Children’s Hospital San Diego, San Diego, CA
bUTHealth McGovern Medical School, Houston, TX
cDepartment of Dermatology, Henry Ford Medical Center, Detroit, MI
dCassiopea Inc., San Diego, CA
eCassiopea S.p.A., Lainate, Italy 
fPharmapace Inc., San Diego, CA
gSun Pharmaceutical Industries, Inc., Princeton, NJ

Abstract
Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥ 12 years based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne. Safety and efficacy of clascoterone in patients aged ≥ 12 years from an open-label, long-term extension study are presented. 
Methods: Enrolled patients applied clascoterone cream 1% twice daily to the entire face and, if desired by the patient and/or investigator, truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from IGA at each visit among those completing the study per-protocol (PP); face and trunk were evaluated individually. 
Results: Of 600 patients aged ≥ 12 years (original randomization: 311 clascoterone, 289 vehicle), 343 completed the extension study (177 clascoterone, 166 vehicle). There were 187 TEAEs in 108/598 clascoterone-treated patients (18.1%), including 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively; the most common LSRs (previous clascoterone/vehicle) were erythema (face, 8.0%/7.7%) and scaling/dryness (face, 10.0%/7.3%). The percentage of PP patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at study end.
Conclusions: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged ≥ 12 years. 

Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-term safety and efficacy of twice-daily topical clascoterone cream 1% in patients ≥ 12 years of age with acne vulgaris. J Drugs Dermatol. 2023;22(8):810-816. doi:10.36849/JDD.7592

INTRODUCTION

Acne vulgaris is a chronic skin condition characterized by excess sebum production, hyperkeratinization, Cutibacterium acnes colonization, and inflammation.1 Acne vulgaris affects approximately 85% of adolescents and young adults between 12 and 25 years of age, attributable in part to the influence of pubertal hormonal changes, but can also persist into adulthood.2 Androgens such as dihydrotestosterone (DHT) play a key role in driving acne pathogenesis via expression of genes that mediate sebum production and inflammation.2-4 Antiandrogen medications for acne vulgaris include off-label use of spironolactone and combined oral contraceptives,3,5 although these medications are not suitable for use in males.3 Long-term spironolactone treatment is also associated with a potential risk of hyperkalemia, and laboratory monitoring is recommended, particularly for patients with impaired renal function or concomitant use of drugs that elevate potassium levels.6 

Clascoterone cream 1%, a novel topical androgen receptor inhibitor,7 was approved in the US in 2020 for the treatment of acne vulgaris in males and females greater than or equal to 12 years of age.8 Clascoterone has a steroidal structure similar to DHT and inhibits the binding of DHT to androgen receptors in vitro.9,10 Clascoterone is rapidly hydrolyzed to cortexolone, a primary inactive metabolite, resulting in low quantifiable plasma levels of clascoterone after topical application, and therefore, low systemic exposure.11,12  The efficacy and safety of clascoterone 
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