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Clascoterone (Winlevi) cream was safe and effective for up to 12 months in patients with acne ages 12 and older, and may in fact become more efficacious over time.

That's according to results of an extension study that appears in the.

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 and resume treatment if needed. Of 600 patients ages 12 and older (original randomization: 311 clascoterone, 289 vehicle) included in the original study, 343 completed the extension study (177 clascoterone, 166 vehicle).

Participants reported 187 adverse events in 108/598 clascoterone-treated patients (18.1%); these affected 56/311 (18.0%) and 52/287 (18.1%) patients originally randomized to clascoterone and control groups, respectively. The percentage of patients with facial and truncal IGA 0/1 increased to 48.9% (156/319) and to 52.4% (65/124), respectively, among those who completed the study per protocol.

The study was conducted by a team of U.S.-based researchers, including first author Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and professor of dermatology and pediatrics and vice-chair of the department of dermatology at University of California San Diego School of Medicine. The following study excerpts have been lightly edited for length and clarity.

What was the key objective of this trial?

Clascoterone cream 1%, a novel topical androgen receptor inhibitor, was approved in the U.S. in 2020 for the treatment of acne vulgaris in males and females ages 12 years and older.

The cream's efficacy and safety were assessed in two identical Phase 3 clinical trials and in a long-term extension study in patients ages 9 and older with moderate-to-severe acne vulgaris. In the Phase 3 pivotal studies, treatment with clascoterone cream 1% resulted in significant clinical improvement compared with vehicle cream after 12 weeks of twice-daily application, with a favorable safety profile.

Clascoterone safety was well maintained for up to an additional 9 months of treatment in patients ages 9 and older with moderate-to-severe acne vulgaris. Here, the study team presented long-term safety and efficacy data in the subgroup of clinical trial patients ages 12 and older who entered the long-term extension study.

What were the key findings?

This 9-month extension study confirmed the favorable safety profile of clascoterone cream 1% in the long-term treatment of patients ages 12 and older with moderate-to-severe facial and/or truncal acne vulgaris. The frequencies of treatment-emergent adverse events (TEAE) and local skin reactions were low throughout the study. Most of the TEAEs were mild, and no accumulation of adverse events was observed over time.

The proportions of patients with facial and truncal IGA 0/1 increased over time and were highest at the end of the study, indicating that clascoterone efficacy continued to increase with long-term treatment. These results suggest that clascoterone may be a suitable option for long-term topical treatment of both facial and truncal acne vulgaris in patients in this age group.

What was the safety profile after the extension period?

Overall, 108/598 (18.1%) patients in the safety population experienced a total of 187 TEAEs; frequency was similar between patients previously treated with clascoterone (56/311 [18.0%]) versus vehicle (52/287 [18.1%]). Most TEAEs were mild or moderate and not considered 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 had TEAEs leading to study discontinuation. The most frequent TEAEs by percentage of patients affected included nasopharyngitis (17 [2.8%]), upper respiratory tract infection (11 [1.8%]), sinusitis (5 [0.8%]), viral respiratory tract infection (5 [0.8%]), and application site acne (4 [0.7%]) among all patients.

What are the key takeaways for dermatologists?

This and previous studies support clascoterone as an option for long-term treatment of acne vulgaris.

The proportion of patients whose skin was clear or almost clear increased at each visit and was highest at the end of the study, indicating that clascoterone efficacy improved over time for up to 12 months in patients with moderate-to-severe acne vulgaris.