Safety and efficacy of a once-daily halobetasol propionate 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis: Results of two phase 3 randomized controlled trials
Article
Green, LJ, Kerdel, FA, Cook-Bolden, FE et al. (2018). Safety and efficacy of a once-daily halobetasol propionate 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis: Results of two phase 3 randomized controlled trials
. JOURNAL OF DRUGS IN DERMATOLOGY, 17(10), 1062-1069.
Green, LJ, Kerdel, FA, Cook-Bolden, FE et al. (2018). Safety and efficacy of a once-daily halobetasol propionate 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis: Results of two phase 3 randomized controlled trials
. JOURNAL OF DRUGS IN DERMATOLOGY, 17(10), 1062-1069.
Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. Objective: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. Results: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P<0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs >1%. Limitations: Study did not include subjects with BSA greater than 12. Conclusions: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course.
