On September 21, 2021 Mayne Pharma announced that the U.S. Food and Drug Administration (FDA) approved LEXETTE® (halobetasol propionate) foam, 0.05% for the treatment of plaque psoriasis in patients aged 12 years and older.
Topical steroids are classified by potency. LEXETTE is classified as a super potent topical corticosteroid, making it one of the topical steroid treatments with the highest potency available. It was originally approved by the FDA in 2018, based on evidence from multicenter, randomized, double-blind, vehicle-controlled studies. A follow-on open label study in adolescent patients (12-17 years) with plaque psoriasis provided additional data , resulting in approval and thus providing another option for this population.