From the Guidelines
Clascoterone cream is conditionally recommended for the treatment of acne vulgaris, as evidenced by the most recent guidelines from the Journal of the American Academy of Dermatology 1.
Key Points
- The guidelines present 18 evidence-based recommendations and 5 good practice statements for the management of acne vulgaris.
- Clascoterone is conditionally recommended due to its high certainty of evidence, as stated in the guidelines 1.
- The medication works as a topical androgen receptor inhibitor, addressing the hormonal component of acne pathogenesis directly at the skin level.
- Common side effects are mild and include erythema, pruritus, and scaling at the application site.
- Clascoterone has a favorable safety profile with minimal systemic absorption, making it suitable for both males and females without concerns about systemic hormonal effects.
Recommendations
- For optimal results, patients should apply a thin layer to affected areas twice daily, morning and evening.
- Clascoterone can be used in combination with other topical acne treatments as part of a comprehensive regimen.
- The guidelines recommend combining topical therapies with multiple mechanisms of action and limiting systemic antibiotic use to reduce the development of antibiotic resistance and other complications 1.
Evidence
- The evidence comes from a systematic review and guidelines published in the Journal of the American Academy of Dermatology, which analyzed data from multiple clinical questions and resulted in 18 evidence-based recommendations and 5 good practice statements 1.
- The guidelines provide a comprehensive overview of the treatment options for acne vulgaris, including topical and oral medications, and recommend clascoterone as a conditional treatment option due to its efficacy and safety profile.
From the FDA Drug Label
WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1) Most common adverse reactions occurring in 7 to 12% of patients are erythema/reddening, pruritus and scaling/dryness. The evidence base for the use of clascoterone cream in the treatment of acne vulgaris is that it is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older 2. The most common adverse reactions are erythema/reddening, pruritus, and scaling/dryness.
- Key points:
- Indication: topical treatment of acne vulgaris
- Patient age: 12 years and older
- Common adverse reactions: erythema/reddening, pruritus, scaling/dryness The FDA drug label supports the use of clascoterone cream for the treatment of acne vulgaris, with a specific dosage and administration regimen and warnings and precautions to consider 2.
From the Research
Evidence Base for Clascoterone Cream in Acne Vulgaris Treatment
- Clascoterone cream 1% is a novel, first-in-class topical antiandrogen therapy approved for the treatment of acne vulgaris in patients 12 years and older 3.
- The medication works by competing with dihydrotestosterone (DHT) for androgen receptors in pilosebaceous units, inhibiting the acnegenic downstream effects of DHT such as lipid synthesis and inflammatory cytokine production in a dose-dependent manner 3.
- Two phase III clinical trials have demonstrated the efficacy of clascoterone 1% cream in treating acne vulgaris, with significant reductions in inflammatory and noninflammatory lesions compared to placebo cream 3, 4, 5.
- Clascoterone has a favorable safety profile, with no systemic antiandrogenic effects observed in clinical studies, making it a valuable treatment option for patients who are not candidates for systemic drugs due to contraindications or adverse effects 3, 4, 6.
Comparison with Other Treatments
- Clascoterone offers a novel mechanism of action, with efficacy rates similar to those of current medications, but without the systemic side effects associated with systemic antiandrogen medications 4.
- The medication may be placed ahead of other androgen receptor antagonists, such as spironolactone, due to its avoidance of systemic side effects 4.
- Large-scale trials are required to assess the efficacy of clascoterone against its comparators and in combination with existing acne therapies 5.
Patient Population
- Clascoterone is approved for the treatment of acne vulgaris in patients 12 years and older, making it a suitable treatment option for both male and female patients in this age group 3, 6.
- The medication provides a safe and effective treatment option for patients who are not candidates for systemic drugs due to contraindications or adverse effects, or who have failed other topical therapies 6.