Nulevi Cream

Nulevi cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Clascoterone (cortexolone 17 α-propionate) 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. Circulating and locally synthesized natural ligands, testosterone and dihydrotestosterone (DHT), serve as causative factors in both males and females. Upon binding of DHT, the DHT-androgen receptor complex dimerizes and translocates to the nucleus where it promotes the transcription of genes involved in acne pathogenesis, including proliferation and differentiation of sebocytes, excess sebum production, and inflammatory cytokine production. Clascoterone is a potent antagonist at ARs and competes for androgens in binding to the receptor, thereby inhibiting downstream signalling of ARs that promote acne.

Androgenetic alopecia is also an androgen-dependent and highly genetic condition. Dihydrotestosterone (DHT) binds to ARs expressed on dermal papilla cells (DPC) in the scalp to induce AR-mediated transcription of genes that contribute to androgenic alopecia. By blocking the interaction between DHT and aARs, clascoterone inhibits AR-regulated transcription and DHT-induced IL-6 synthesis.

Clean the affected area gently then apply a thin uniform layer (approximately 1 gm) of Clascoterone
cream twice per day in the morning and evening to the affected area. Avoid accidental transfer of Clascoterone cream into eyes, mouth, or other mucous membranes. If contact with mucous membranes occurs, this should be rinsed thoroughly with water or as directed by physician.

Use in Children and Adolescents: Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris have not been established in pediatric patients under 12 years of age

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

Data of contraindication of clascoterone cream in not available.

Most common adverse reactions occurring in 7% to 12% of patients are erythema/ reddening, pruritus, and scaling/dryness. Additionally, >3% of patients may suffer from edema, stinging and burning.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two identical multicenter, randomized, double-blind, vehicle-controlled trials, 1421 subjects 12 years and older with facial acne vulgaris applied Nulevi cream or vehicle twice daily for 12 weeks. Overall, 62% of the subjects were female, and 38% were male, 91% of the patients were Caucasian, and the mean age was 19.7 years.

Local skin reactions (edema, erythema/redness, pruritus, scaling/dryness, skin atrophy, stinging/burning, striae rubrea, telangiectasia) were observed during the 12-week treatment and occurred in a similar percentage of subjects treated with vehicle.

There is no available data on clascoterone cream use in pregnant women to evaluate a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There is no data regarding the presence of Clascoterone or metabolite in human milk or the effects on milk production and breastfed infant.

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

There is no experience of over dosage with Nulevi.

Acne treatment preparations

For indications & dosage, please see the enclosed leaflet. To be dispensed only on the prescription of a registered physician. 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 the reach of children.