Clascoterone (Winlevi) cream is safe and effective for up to 12 months in acne sufferers 12 years and older, and may actually become more effective over time.
This is based on what was published in Journal of Dermatological Drugs.
Roll-up patients will apply 1% clascoterone cream twice daily to the entire face and to truncal acne if indicated by the patient and/or investigator for up to 9 months.
Patients who achieved an Investigator Global Assessment score of 0 or 1 (IGA 0/1) could discontinue and resume treatment if necessary. Of the 600 patients 12 years and older enrolled in the original study (original randomization: 311 clascoterone, 289 carrier), 343 patients completed the extension study (177 clascoterone, 166 carrier).
Participants reported 187 adverse events in 108/598 patients (18.1%) who received clascoterone; these affected 56/311 (18.0%) and 52/287 (18.1%) initially randomized to clascoterone and control %) patients. Among patients who completed the study per protocol, the proportions of patients with facial and trunk IGA 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively.
The study was conducted by a team of U.S. researchers, including first author Lawrence Eichenfield, chief of pediatrics and adolescent dermatology, professor of dermatology and pediatrics, and vice chair of dermatology at Rady Children’s Hospital in San Diego. Medical PhD. UC San Diego School of Medicine. The following excerpts from the study have been lightly edited for length and clarity.
What is the main goal of this trial?
Clascoterone Cream 1% is a novel topical androgen receptor inhibitor approved in the United States in 2020 for the treatment of acne vulgaris in men and women aged 12 years and older.
The cream’s efficacy and safety were evaluated in two identical Phase 3 clinical trials and a long-term extension study in patients 9 years and older with moderate to severe acne vulgaris. In a Phase 3 pivotal study, treatment with clascoterone 1% cream resulted in significant clinical improvement compared with vehicle cream after 12 weeks of twice-daily use, with a favorable safety profile.
In patients 9 years and older with moderate to severe acne vulgaris, the safety profile of Clascoterone was well maintained up to 9 months of additional treatment. Here, the team presents long-term safety and efficacy data on a subgroup of clinical trial patients aged 12 years and older who entered the long-term extension study.
What were the main findings?
This 9-month extension study confirms the favorable safety profile of clascoterone cream 1% in the long-term treatment of patients 12 years and older with moderate to severe acne vulgaris on the face and/or trunk. The incidence of treatment-emergent adverse events (TEAEs) and local skin reactions was low throughout the study. Most TEAEs were mild, and no accumulation of adverse events was observed over time.
The proportion of patients with facial and trunk IGA 0/1 increased over time and was highest at the end of the study, suggesting that the efficacy of clascoterone continues to increase with long-term treatment. These results suggest that clascoterone may be a suitable option for long-term topical treatment of acne vulgaris on the face and trunk in patients in this age group.
How safe is the extended period?
Overall, 108/598 (18.1%) patients in the safety population experienced a total of 187 TEAEs; patients previously treated with clascoterone (56/311 (18.0%)) versus vehicle-treated patients (52/287 ( 18.1%))). Most TEAEs were mild or moderate and were not related to clascoterone treatment.
A total of 6/598 (1.0%) patients reported serious adverse events, none of which were considered related to clascoterone treatment; 9/598 (1.5%) patients experienced TEAEs, leading to study discontinuation. The most common TEAEs, by percentage of affected patients, included nasopharyngitis (17 (2.8%)), upper respiratory tract infection (11 (1.8%)), sinusitis (5 (0.8%)), viral respiratory tract infection (5 cases (0.8%))), and application site acne (4 cases (0.7%)) in all patients.
What are the key takeaways for dermatologists?
This study and previous research support clascoterone as an option for the long-term treatment of acne vulgaris.
The proportion of patients with clear or nearly clear skin increased with each visit and reached a maximum at the end of the study, demonstrating increasing efficacy of clascoterone in patients with moderate to severe acne vulgaris over a period of up to 12 months.
Eichenfield is an employee of the University of California, San Diego and has received compensation from Cassiopea SpA for research participation; he also reports relationships with Almirall, Dermata, Galderma Laboratories, and Ortho Dermatologics.