Topical Foam Treatment Now Indicated for Adolescents With Psoriasis

The FDA has announced the approval of halobetasol propionate foam, 0.05%, for use in patients aged 12 years and older.

The super potent topical corticosteroid was previously approved in May 2018 for adults with plaque psoriasis based on the results of two multicenter, randomized, double-blind, vehicle-controlled studies involving 560 patients with plaque psoriasis of 2% to 12% body surface area. This latest indication for adolescents comes after additional data were obtained in a follow-on open label study with patients aged 12 to 17 years.

Dr Neal Bhatia, director of clinical dermatology at the therapeutics Clinical Research in San Diego, CA, and an investigator in the phase 3 study of halobetasol propionate foam, said “Traditionally, the use of halobetasol has been limited by inconvenient vehicles, which decreased patient compliance, as well as by age and duration restrictions for super potent steroids. With the versatility and tolerability of the foam, [halobetasol propionate foam] offers the power of a super potent steroid and the potential to treat adolescents with more affected surface areas. Favorable results were demonstrated in the adolescent trial and were comparable to the foam's previously shown safety, efficacy, and tolerability in adults."

Reference
FDA approves LEXETTE (R) adolescent plaque psoriasis. Press release. Mayne Pharma; September 21, 2021. Accessed September 21, 2021. https://prnmedia.prnewswire.com/news-releases/fda-approves-lexette-r-for-adolescent-plaque-psoriasis-301381150.html