CLASCOTERONE CREAM,TOP

Clinical Criteria Summary

• Topical treatment of acne vulgaris in patients 12 years of age and older
• FDA-approved for the treatment of acne without regard to severity or affected body area

• HPA axis suppression occurred in 5% of evaluated adults; incidence was higher in adolescents (9%) and pediatric patients aged 9–11 years (15%)
• Hyperkalemia risk was not increased in study patients ≥12 years old, but risk in actual clinical practice, elderly patients, or with concurrent hyperkalemia-causing drugs remains unknown
• Local skin reactions occurred at similar rates to vehicle
• Adverse events of special interest include hyperkalemia, gynecomastia, and menstrual irregularities (polycystic ovaries/amenorrhea noted in long-term study)
• Geriatric use: Insufficient data; extent of systemic absorption and risk of HPA axis suppression in patients >58 years are unknown

• Not approved for children aged 9 to 11 years due to lack of efficacy in that subgroup and increased risks of HPA axis suppression (10%) and hyperkalemia (33.3%)
• No data in pregnant women; teratogenic in animals
• No human data for lactation

• May be used as an alternative topical treatment option for patients with acne vulgaris who have had an inadequate response or intolerance to two- or three-drug topical combination therapy including benzoyl peroxide, a retinoid and/or antibiotic
• Safety and efficacy of clascoterone cream in combination therapy have not been evaluated
• Topical therapies are generally used for mild to moderate acne and can serve as adjuncts to systemic antibiotics for severe acne

• Pharmacy storage: Refrigerate between 36°F and 46°F (2°C and 8°C)
• Storage after dispensing: Room temperature between 68°F and 77°F (20°C and 25°C); do not freeze. Discard unused product 180 days after dispensing or 1 month after first opening, whichever is sooner

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