STEPS
New Drug Reviews
Clascoterone (Winlevi) for the Treatment of Acne
Am Fam Physician. 2021 Jul ;104(1):93-94.
Clascoterone (Winlevi) is an androgen receptor inhibitor labeled for the topical treatment of acne vulgaris in patients 12 years and older.
| Drug | Starting dose | Dose form | Cost* |
|---|---|---|---|
Clascoterone (Winlevi) | Apply topically morning and night | 60-g tube: 1% cream | $580 |
*—Estimated lowest price for one 60-g tube. Actual cost will vary with insurance and by region. Information obtained at http://www.wellrx.com (accessed May 17, 2021; zip code: 66211).
| Drug | Starting dose | Dose form | Cost* |
|---|---|---|---|
Clascoterone (Winlevi) | Apply topically morning and night | 60-g tube: 1% cream | $580 |
*—Estimated lowest price for one 60-g tube. Actual cost will vary with insurance and by region. Information obtained at http://www.wellrx.com (accessed May 17, 2021; zip code: 66211).
Safety
Two studies of 722 patients receiving clascoterone demonstrated a low frequency of adverse effects related to treatment.1,2 The overall safety profile of clascoterone in these studies was similar to that of the vehicle cream.3,4 Topical use of clascoterone has low systemic exposure.1 However, given the structural similarities to the oral antiandrogen spironolactone, which can cause systemic adverse effects such as hyperkalemia, gynecomastia, and menstrual irregularities, additional study was required.5 Laboratory-detected hypothalamic-pituitary-adrenal axis suppression and hyperkalemia occurred in a small number of patients with no significant clinical impact on reported symptoms or blood pressure.1 Clascoterone is not labeled for use in children younger than 12 years. There are limited data about the safety of clascoterone during pregnancy, and further research is needed on the effects of clascoterone, including the risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes.1,2
Tolerability
Clascoterone is generally well tolerated. The most common adverse effects are irritation at the site of application, including itching, redness, burning, and peeling in 7% to 12% of patients.3 These effects tend to be mild and do not result in significant rates of treatment discontinuation.1
Effectiveness
Two randomized controlled studies that included a total of 1,440 patients
References
show all references1. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. NDA/BLA multidisciplinary review and evaluation: NDA 213433. Winlevi (clascoterone) cream, 1%. Accessed March 16, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213433Orig1s000MultidisciplineR.pdf...
2. U.S. Food and Drug Administration. Drug label information. Winlevi (clascoterone) cream. Accessed March 1, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf
3. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials. JAMA Dermatol. 2020;156(6):621–630.
4. Eichenfield L, Hebert A, Stein Gold L, et al. Open-label, long-term extension study to evaluate the safety of clascoterone (CB-03-01) cream, 1% twice daily, in patients with acne vulgaris. J Am Acad Dermatol. 2020;83(2):477–485.
5. Brown J, Farquhar C, Lee O, et al. Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne. Cochrane Database Syst Rev. 2009;(2):CD000194.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.
A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.
Copyright © 2021 by the American Academy of Family Physicians.
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