Clascoterone

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. Acne is a multifactorial skin condition characterized by excess sebum production, epithelial hyperkeratinization, proliferation of the skin commensal bacteria, and inflammation.

• 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.

Clascoterone binds to androgen receptors, blocking androgen-mediated signaling that promotes sebaceous gland proliferation, sebum production, and inflammatory pathways, thereby treating acne vulgaris.

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.

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. Avoid accidental transfer into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

If you miss a dose of Clascoterone cream, apply it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

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

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

• 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.

Data of contraindication of clascoterone cream is not available.

No clinical study evaluating the drug interaction of clascoterone cream has been conducted.

No food interactions have been found or established.

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

There is no data regarding the presence of Clascoterone or metabolite in human milk or the effects on milk production and breastfed infant. Consult your doctor before use.

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

Limited information is available regarding dose adjustment for elderly patients.

Limited information is available regarding use in kidney or liver problems.

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.

Clascoterone