Abstract

Topical minocycline foam4% (Amzeeq™) is approved in the USA for the treatment of inflammatory lesions of non-nodular, moderate to severe acne vulgaris (acne) in patients aged ≥ 9years. It was developed to minimize systemic minocycline absorption and toxicity, and its high lipid content allows efficient drug movement through sebum and into affected sites. The favorable in vitro resistance profile of oral minocycline seen in Cutibacterium acnes (C. acnes) isolates was maintained with topical minocycline foam4%. In 12-week, phaseIII clinical trials, once-daily topical minocycline foam4% significantly improved both inflammatory and noninflammatory lesions relative to foam vehicle in patients aged ≥ 9years with moderate to severe acne and was reported by most patients to be satisfactory or highly satisfactory to use. Extension trial data indicated that topical minocycline foam4% continued to be effective for up to 52weeks' therapy. Topical minocycline foam4% was generally well tolerated in these patients, with most adverse events (AEs) and all serious AEs considered to be unrelated to treatment. Cutaneous AEs were uncommon, and findings from a dermal safety study showed that topical minocycline foam4% did not have any effects related to phototoxicity, photoallergy, skin sensitization and skin irritation. Topical minocycline foam 4% is thus a useful addition to available treatment options for the management of inflammatory lesions of non-nodular, moderate to severe acne in adult and pediatric patients aged ≥ 9 years.

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