Clascoterone cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients aged 12 years and above.

Clascoterone (cortexolone 17 α-propionate) is a novel androgen receptor antagonist with strong binding affinity to androgen receptors. It works by competing with androgens for receptor binding, thereby blocking androgen receptor signaling pathways involved in acne development, such as sebaceous gland growth, excess sebum production, and inflammation.

Acne is a complex skin disorder characterized by increased sebum production, abnormal keratinization of epithelial cells, bacterial proliferation, and inflammation. Natural androgens like testosterone and dihydrotestosterone (DHT), produced locally and systemically, play a key role in both males and females. When DHT binds to androgen receptors, the receptor complex moves to the nucleus and activates gene transcription related to acne formation, including sebocyte proliferation, increased sebum secretion, and inflammatory cytokine production. Clascoterone blocks this process by inhibiting androgen receptor activation and downstream signaling.

Androgenetic alopecia is another androgen-dependent condition with a strong genetic component. DHT interacts with androgen receptors in dermal papilla cells of the scalp, triggering gene expression that leads to hair loss. By blocking the interaction between DHT and androgen receptors, Clascoterone reduces androgen-mediated gene activity and decreases IL-6 synthesis associated with this process.

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 studies have been conducted to evaluate the drug interaction profile of clascoterone cream.

There is no available data regarding the contraindications of clascoterone cream.

The most commonly reported adverse reactions, occurring in about 7% to 12% of patients, include erythema (redness), itching, and scaling or dryness of the skin. Additionally, more than 3% of patients may experience edema, stinging, and burning sensations.

Since clinical trials are conducted under varying conditions, the observed rates of adverse reactions may differ from those seen with other medications and may not necessarily reflect real-world usage.

In two identical multicenter, randomized, double-blind, vehicle-controlled clinical trials, 1421 patients aged 12 years and older with facial acne vulgaris used clascoterone cream or vehicle twice daily for 12 weeks. Among them, 62% were female and 38% were male; 91% were Caucasian, with an average age of 19.7 years.

Local skin reactions such as edema, redness, itching, scaling or dryness, skin atrophy, stinging or burning, striae rubrae, and telangiectasia were observed during the 12-week treatment period and occurred at similar rates in both treatment and vehicle groups.

There is no adequate data available on the use of clascoterone cream in pregnant women to determine the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Additionally, there is no information on the presence of clascoterone or its metabolites in human milk, nor on its effects on milk production or breastfed infants.

• Local irritation: Itching, burning, redness, or peeling of the skin may occur with clascoterone cream. If these reactions develop, reduce the frequency of use or discontinue the treatment.
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur during or after treatment.
• Pediatric patients may be more prone to systemic toxicity.
• Hyperkalemia: Increased potassium levels have been observed in some patients during clinical studies.

There is no reported experience of overdose with clascoterone.

Acne treatment preparations

For dosage and usage instructions, refer to the enclosed leaflet. This medicine should be dispensed only with a registered physician’s prescription. Protect from light and store in a dry place. Store at 2°–8°C before dispensing. During use, it can be kept at room temperature (20°–25°C) for up to 90 days. Keep out of reach of children.