Findings based on two phase 3 trials of halobetasol propionate lotion versus vehicle
WEDNESDAY, Oct. 10, 2018 (HealthDay News) — Halobetasol propionate 0.01 percent lotion (BRYHALI Lotion) appears safe and effective for the treatment of moderate-to-severe plaque psoriasis, according to the results of two phase 3 trials published in the October issue of the Journal of Drugs in Dermatology.
Lawrence J. Green, M.D., from George Washington University in Washington, D.C., and colleagues randomized (2:1) 430 patients to receive halobetasol propionate Lotion or vehicle once daily for eight weeks, with assessments at two, four, six, and eight weeks of treatment as well as at a four-week post-treatment follow-up visit.
The researchers found that the halobetasol propionate lotion was consistently more effective than the vehicle in achieving treatment success (defined as at least a two-grade improvement from baseline in an Investigator Global Assessment score and “clear” or “almost clear” skin). At eight weeks, 36.5 percent (Study 1) and 38.4 percent (Study 2) of lotion patients achieved treatment success versus 8.1 and 12 percent of patients, respectively, receiving vehicle. There was no rebound of symptoms at the four-week post-treatment assessment. A similar number of patients in the lotion and vehicle groups reported adverse events (21.5 and 23.9 percent, respectively), and only 1.8 percent of reported adverse events were considered treatment-related.
“If approved, BRYHALI Lotion can provide physicians and their patients with a new treatment option with a longer duration of use,” a coauthor said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Ortho Dermatologics, which manufactures halobetasol propionate and funded the study.
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