Topical
minocycline foam 4% (Amzeeq™) is approved in the USA for the treatment of inflammatory lesions of non-nodular, moderate to severe
acne vulgaris (
acne) in patients aged ≥ 9 years. 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 foam 4%. In 12-week, phase III clinical trials, once-daily topical
minocycline foam 4% significantly improved both inflammatory and noninflammatory lesions relative to foam vehicle in patients aged ≥ 9 years 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 foam 4% continued to be effective for up to 52 weeks'
therapy. Topical
minocycline foam 4% 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 foam 4% 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.