The FDA has approved halobetasol propionate foam, a potent topical corticosteroid, to treat adolescents aged 12 and older with plaque psoriasis, according to a press release from the manufacturer.
Balobetasol propionate foam is already approved for adult patients with plaque psoriasis involving between 2% and 12% of body surface area. The approval for adolescents was based on findings from a follow-up open label study in patients aged 12 to 17 years.
“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,” lead author Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, said in the release. “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.”
Bhatia added that safety and efficacy results from the study were similar for adults and children. The release noted that local adverse reactions associated with topical corticosteroids can include atrophy, burning, itching, and irritation, adding that the reactions may be more likely with prolonged use or higher potency corticosteroids. Topical corticosteroids also have a risk of systemic effects, including Cushing’s syndrome, hyperglycemia, and glucosuria.
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