Topical clascoterone, sold as Winlevi (clascoterone cream 1%), helps some teens with inflammatory acne, but trial wins were modest and short term. Two identical 12-week trials in moderate-to-severe facial acne met all three primary goals, including inflammatory-lesion change. Teens were included directly, with 641 participants ages 12-18, according to Medical Bag's FDA data report. FDA approved the cream on August 26-27, 2020 for acne vulgaris in patients 12 years and older, as described by Cassiopea via Drugs.com in the FDA approval notice.
Medical information disclaimer: This article is for general educational purposes only and does not provide medical advice, diagnosis, or treatment. Always consult a physician or other qualified health professional about symptoms, medications, tests, or treatment decisions.
Table of Contents
- How were the Phase 3 trials built?
- What changed for inflammatory breakouts?
- How far does the evidence reach for teens?
- What does daily treatment involve?
How were the Phase 3 trials built?
The JAMA Dermatology original study describes two identical 12-week trials. They were multicenter, randomized, double-blind, and vehicle-controlled. They enrolled 1,440 males and nonpregnant females age 9 and older with moderate-to-severe facial acne.
Participants applied clascoterone cream 1% or vehicle twice daily. Sun Pharma's AAD 2022 summary lists three co-primary endpoints at week 12. Success meant a score of clear or almost clear with at least a two-point drop on the Investigator's Global Assessment. The other endpoints were absolute change in non-inflammatory and inflammatory lesion counts, and Winlevi beat vehicle on all three.
What changed for inflammatory breakouts?
Drugs.com summary of trial results reports IGA success of 18.8% and 20.9% for Winlevi. Vehicle success was 8.7% and 6.6% in the two trials. Success meant clear or almost clear skin with at least a two-point improvement.
The same Drugs.com summary reports mean inflammatory-lesion reductions of 44.6% and 47.1% for Winlevi. Vehicle reductions were 36.3% and 29.7%. Most patients did not reach clear or almost clear by week 12.
How far does the evidence reach for teens?
Medical Bag reporting FDA data counts 641 trial participants ages 12 to 18. That teen enrollment supports the 12-years-and-older use that includes adolescents with inflammatory lesions.
JAMA authors stated that small samples for age and race limit conclusions for subpopulations. They also called for longer safety follow-up beyond 12 weeks. Health Canada excluded ages 9 to under 12 because of safety findings and efficacy uncertainty.
What does daily treatment involve?
NLM DailyMed labeling describes clascoterone as a topical androgen receptor inhibitor. It competes with dihydrotestosterone in sebaceous glands to reduce sebum and inflammatory signals, although labeling states the acne mechanism is unknown. Drugs.com package insert directions call for a thin layer applied twice daily.
Monitoring focuses on skin tolerance and hormonal effects. Watch for these effects during use: Drugs.com package insert notes children may be more susceptible to HPA-axis suppression, with reversibility 4 weeks after stopping. Keep twice-daily use thin and ask the prescriber about monitoring for local and hormonal effects.
- redness (erythema)
- itching (pruritus)
- scaling or dryness
- signs of HPA-axis suppression
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