“Traditionally, a lotion has not been the vehicle of choice for treating psoriasis given perceptions about penetration, but it might be preferred by patients over ointments or foams for use on the lower extremities.”
The analysis of adverse event data from the two phase 3 studies showed there were minimal safety concerns associated with the eight-week treatment course, he says.
“Potent topical corticosteroids are generally approved for use over two to four consecutive weeks because of safety issues,” he explains. “This lower concentration of a potent corticosteroid brings new flexibility and safety for longer treatment duration.”
The post hoc analysis included data from 234 participants in two multicenter, randomized, double- blind, vehicle-controlled studies. The subjects were randomized 2:1 to once-daily treatment. with halobetasol 0.01% lotion or vehicle. Treatment continued for eight weeks and patients were followed for four weeks thereafter.
The efficacy endpoints included treatment success, defined as a ≥2-grade improvement from baseline in individual signs of psoriasis (erythema, plaque elevation, and scaling) and overall treatment success, defined as a ≥2-grade improvement from baseline in the Investigator Global Assessment (IGA) score and a rating of “clear” or “almost clear.” The three psoriasis signs and IGA scores used a 5-point rating scale where 0=none and 4=severe.
To be eligible for enrollment, patients had to have a score ≥2 for all three psoriasis signs, a score of 3 or 4 for at least two of the signs and a total score ≥8. In addition, they were required to have an IGA score of 3 or 4. Eligible patients also had to have an overall body surface area (BSA) ranging from ≥3% to 12%.
Dr. Bhatia is an advisor and/or investigator for Bausch Health.
1. Bhatia ND, Vlahovic TC, Green LG, Martin G, Lin T. J Drugs Dermatol. 2019;18(10):1029-1036