Acnev

• Acne vulgaris (patients 12 years and older)
• Androgenetic alopecia

Clascoterone is a novel antagonist of androgen receptors. It binds to androgen receptors with high affinity. By competing with androgens for binding to androgen receptors, Clascoterone works by blocking the androgen receptor signaling cascades that promotes acne pathogenesis such as sebaceous gland proliferation, excess sebum production and inflammatory pathways. Androgenetic alopecia is also an androgen-dependent and highly genetic condition. By blocking the interaction between DHT and ARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.

Dosage: Clean the affected area gently, then apply a thin uniform layer (approximately 1 gm) twice per day in the morning and evening to the affected area.

Children and Adolescents: Safety and effectiveness have not been established in pediatric patients under 12 years of age.

Common Side Effects (7%-12% of patients):

• Erythema/reddening
• Pruritus
• Scaling/dryness
• Edema (>3%)
• Stinging and burning (>3%)

There is no available data on clascoterone cream use in pregnant women. Consult your doctor before use.

• Local Irritation: Pruritus, burning, skin redness or peeling may be experienced. If these effects occur, discontinue or reduce the frequency of application.
• Hypothalamic-pituitary-adrenal (HPA) axis suppression may occur during or after treatment.
• Pediatric patients may be more susceptible to systemic toxicity.
• Hyperkalemia: Elevated potassium levels are observed in some subjects during clinical trials.

There is no experience of overdosage with Clascoterone.

Protect from light, keep in dry place. Store at 2°-8°C before dispensing, while in use room temperature 20°-25°C for 90 days. Keep out of reach of children.