<p><strong>Pediatric Use</strong>: Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two identical multicenter, randomized, double-blind, vehicle-controlled, 12-week trials and 2 open-label pharmacokinetic studies. Safety and effectiveness of Clascoterone cream for the topical treatment of acne vulgaris has not been established in pediatric patients under 12 years of age.&nbsp;<br />
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<strong>Geriatric Use</strong>: Clinical studies of Clascoterone cream did not include sufficient numbers of subjects aged 65 years of age and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.</p>