Nulevi Cream (Clascoterone): First-in-Class Topical Androgen Receptor Inhibitor

Nulevi cream contains Clascoterone (17 $\alpha$-propionate), a novel, non-steroidal androgen receptor inhibitor. Unlike traditional treatments that focus on bacteria or skin shedding, Clascoterone targets the underlying hormonal triggers of acne directly at the skin layer.

It competes directly with natural male hormones, specifically dihydrotestosterone ($DHT$), blocking the signaling pathways that cause sebaceous gland cell multiplication, excessive oil (sebum) production, and skin inflammation. Because it acts locally on the skin's androgen receptors, it provides hormonal acne control for both males and females without systemic hormonal alterations.

📋 Indications: Targeted Acne Therapy

Nulevi cream is indicated for the topical treatment of acne vulgaris (common hormonal and inflammatory acne) in patients 12 years of age and older.

🥄 Dosage & Proper Administration Protocol

• Dose: Apply a thin, uniform layer (approximately 1 gram) to the completely clean, dry affected skin areas.

• Frequency: Apply twice daily, once in the morning and once in the evening.

• Application Care: Wash hands thoroughly after application. Avoid accidental transfer into the eyes, mouth, nose, or other mucous membranes. If accidental contact occurs, flush the area thoroughly with cool water.

• Age Restriction: Safety and efficacy have not been established for children under 12 years of age.

⚠️ Precautions, Warnings & Local Reactions

• Local Irritation: Mild skin reactions are the most common side effects (occurring in 7% to 12% of patients). These include skin reddening (erythema), itching (pruritus), and dryness or scaling. Mild stinging, burning, or swelling (edema) may also occur. If severe irritation or peeling happens, reduce the application frequency or temporarily stop use.

• HPA Axis Suppression: Because Clascoterone shares a structural backbone with certain corticosteroids, there is a rare risk of temporary Hypothalamic-Pituitary-Adrenal (HPA) axis suppression (adrenal suppression) during or immediately after widespread use. Pediatric patients may absorb higher ratios relative to body weight and are more susceptible to this systemic risk.

• Hyperkalemia Alert: During clinical evaluations, elevated blood potassium levels (hyperkalemia) were observed in a small number of patients.

🛑 Contraindications & Drug Interactions

• Contraindications: There are no officially listed absolute contraindications, though it must be avoided by individuals with a known hypersensitivity to clascoterone or any vehicle components.

• Interactions: No formal clinical drug interaction studies have been conducted for this topical cream.

🤰 Pregnancy & Lactation

• There is no clinical data evaluating the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women. It is also unknown whether topical clascoterone transfers into human breast milk. Use during pregnancy or nursing only if explicitly deemed necessary by your physician.

📦 Storage Conditions (Crucial Transition Temperature)

• Before Dispensing / Stocking: Must be kept under refrigeration between 2°C and 8°C.

• During Patient Use: Once open or at room temperature, store between 20°C and 25°C. The product is stable at room temperature for up to 90 days; any remaining cream must be discarded after 90 days. Keep away from light, and out of reach of children.