Overview
What is it?
Topical clascoterone is a medication used to treat acne vulgaris in patients aged 12 years and older. It is a first-in-class topical antiandrogen, meaning it targets the hormonal causes of acne by blocking androgen receptors in the skin. Unlike systemic treatments, clascoterone works locally with minimal absorption into the bloodstream, making it a safer option for long-term use .
How does it work?
Clascoterone works by competing with dihydrotestosterone (DHT), a hormone that stimulates oil production in the skin, for binding to androgen receptors in the pilosebaceous unit (the hair follicle and oil gland). By blocking these receptors, clascoterone reduces sebum (oil) production and inflammation, which are key contributors to acne development. This localized action helps minimize systemic side effects .
What are the benefits?
Topical clascoterone is effective in reducing both non-inflammatory (like blackheads and whiteheads) and inflammatory (like pimples and cysts) acne lesions. It is well-tolerated, with most side effects being mild to moderate. Clinical trials have shown significant improvements in acne severity, making it a valuable addition to acne treatment options, especially for those who cannot use hormonal therapies like oral contraceptives or spironolactone .
Effectiveness
What does the research say?
Research shows that topical clascoterone is effective in treating moderate to severe acne. In two phase 3 clinical trials, 19.9% of participants using clascoterone achieved treatment success (defined as a significant reduction in acne severity) compared to 7.7% in the placebo group. The medication also reduced non-inflammatory lesions by 20.8 and inflammatory lesions by 19.7 on average, compared to 11.9 and 14.0 in the placebo group, respectively .
Side Effects
Local skin reactions (e.g., redness, dryness, itching)
Local skin reactions such as redness, scaling, dryness, itching, and mild burning or stinging are common but usually mild and temporary .
Nasopharyngitis (common cold symptoms)
Nasopharyngitis, or symptoms of a common cold, were reported in some participants during clinical trials .
Headache
Headaches were observed in a small percentage of users, though they were generally mild and resolved without intervention .
Oropharyngeal pain (sore throat)
Oropharyngeal pain, or sore throat, was reported in some cases but was not severe .
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression (with higher doses)
Reversible HPA axis suppression, a temporary hormonal imbalance, was noted with higher doses but did not cause long-term issues .
Evidence
Clinical Studies & Trials
[1] Guidelines of care for the management of acne vulgaris.
This paper provides guidelines for managing acne vulgaris, a common skin condition affecting adolescents and adults.
View study[2] New Developments in Topical Acne Therapy.
This review highlights recent advancements in topical acne treatments, including clascoterone, a novel antiandrogen.
View study[3] Clascoterone for acne.
This study discusses the efficacy and safety of clascoterone, a topical antiandrogen, for treating acne vulgaris.
View study[4] Topical Clascoterone for Acne Vulgaris.
This paper reviews the role of clascoterone, the first topical therapy targeting the hormonal causes of acne.
View study[5] New Acne Therapies and Updates on Use of Spironolactone and Isotretinoin: A Narrative Review.
This review discusses new acne therapies, including clascoterone, and updates on existing treatments.
View study[6] Innovations in Acne.
This paper explores the latest developments in acne management, including clascoterone and other emerging therapies.
View study[7] Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials.
This study evaluates the efficacy and safety of clascoterone cream in treating facial acne through two phase 3 trials.
View study[8] Clascoterone: First Approval.
This paper discusses the first approval of clascoterone for the treatment of acne vulgaris.
View study[9] The primary role of sebum in the pathophysiology of acne vulgaris and its therapeutic relevance in acne management.
This paper explores the role of sebum in acne development and how treatments like clascoterone target this pathway.
View study[10] Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review.
This systematic review evaluates the efficacy of topical treatments, including clascoterone, for mild-to-moderate acne.
View study