The Food and Drug Administration has expanded the approval of Lexette (halobetasol propionate) foam 0.05% to include patients 12 years of age and older with plaque psoriasis. The treatment was previously approved only in adults 18 years of age and older.
The expanded approval was based on efficacy and safety data from two phase 3 studies (ClinicalTrials.gov Identifier: NCT02368210 and NCT02742441) in adult patients with plaque psoriasis and from an open-label safety study in 24 patients aged 12 to less than 18 years with stable plaque psoriasis covering a minimum of 10% of the total body surface area (BSA) at baseline.
In the adolescent trial, patients were instructed to apply the foam twice daily for up to 2 weeks. Results showed that by day 15, 95.5% of patients had at least a 1-grade improvement in Investigator’s Global Assessment. Moreover, there was a 6% decrease in mean % BSA affected with disease.
Six patients experienced laboratory evidence of adrenal suppression that recovered upon retesting after at least 4 weeks of stopping treatment. There were no serious adverse events reported and none of the patients discontinued treatment due to side effects.
“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,” says Dr Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, an investigator in the phase 3 study, and lead author for the publication on Lexette. “With the versatility and tolerability of the foam, Lexette offers the power of a super potent steroid and the potential to treat adolescents with more affected surface areas.”
Lexette is supplied as 0.05% foam in 50g cans in 1- and 2-count cartons.
- FDA approves Lexette for adolescent plaque psoriasis. News release. Mayne Pharma. Accessed September 21, 2021. https://www.prnewswire.com/news-releases/fda-approves-lexette-r-for-adolescent-plaque-psoriasis-301381150.html.
- Lexette. Package insert. Mayne Pharma; 2021. Accessed September 21, 2021.