Clascon Cream

Acne Vulgaris

Acne Vulgaris Indicated for acne vulgaris Apply thin layer topically to affected area BID

Acne Vulgaris Indicated for acne vulgaris in patients aged >12 years <12 years: Safety and efficacy not established >12 years: Apply thin layer topically to affected area BID

Gently cleanse the affected area; after the skin is dry, apply thin, uniform layer of cream to the affected area(s) twice per day (morning and evening) For topical use only; not for ophthalmic, oral, or vaginal use

May induce local irritation (eg, erythema, redness, pruritus, scaling, dryness); limit concomitant use with other potentially irritating topical products that have a strong drying effect or have high concentrations of alcohol, astringents, spices, or lime

Not Classi Pregnancy No data are available on use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Animal studies Subcutaneous administration to pregnant rats and rabbits during organogenesis at doses 8 or 39 times the maximum recommended human dose, respectively, increased malformations in rats and postimplantation loss and resorptions in rabbits Lactation Data are not available regarding presence of clascoterone or metabolite in human milk, effects on breastfed infants, or effects on milk production

>10% Adverse effects listed below for the drug were similar to those for the vehicle cream in clinical trials Erythema/redness (12.2%) Scaling/dryness (10.5%) 1-10% Adverse effects listed below for the drug were similar to those for the vehicle cream in clinical trials Pruritus (7.7%) Stinging/burning (4.2%) Edema (3.6%) Striae rubrae (2.5%) Skin atrophy (1.6%) Telangiectasia (1.2%) Frequency Not Defined Metabolism: Hyperkalemia Reproductive: Polycystic ovaries, amenorrhea

Exact mechanism of action is unknown; laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles

Clascon 10mg Cream manufactured by Navana Pharmaceuticals Ltd.. Its generic name is Clascoterone topical.