WAILEA, HAWAII – A fixed combination of halobetasol and tazarotene formulated as a once-daily lotion proved safe and effective for patients with moderate or severe plaque psoriasis in a phase II randomized clinical trial, Linda Stein Gold, MD, reported at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
The rationale for developing this product is that it should provide the efficacy of a class 1 superpotent topical corticosteroid, albeit with the topical retinoid lessening concern about the possibility of steroid-induced skin atrophy and other long-term safety issues, explained Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit.
Bruce Jancni/Frontline Medical News
Dr. Linda Stein Gold
The double-blind, multicenter, 8-week, phase II study included 212 patients randomized 2:2:1 to once-daily application of fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% lotion, either topical agent as monotherapy, or vehicle. Ninety percent of participants had moderate plaque psoriasis as defined by a baseline Investigator’s Global Assessment (IGA) score of 3 and a median 5% body surface area involvement. The remaining patients were classified as having severe psoriasis, with a baseline IGA of 4, but no one with psoriasis over more than 12% of their body surface area was eligible for the trial.
The fixed-combination lotion, known for now as IDP-118, established superior efficacy over placebo by 2 weeks. At week 8, treatment success, as defined by at least a two-grade improvement from baseline in IGA score plus a rating of clear or almost clear, was documented in 53% of the IDP-118 lotion group, compared with 33% on halobetasol propionate monotherapy, 19% with tazarotene alone, and 10% with vehicle, Dr. Stein Gold reported.
Each patient had a target lesion 25-32 cm2 in size, which was designated for careful assessment of changes in the domains of lesional erythema, plaque elevation, and scaling. At week 8, the IDP-118 had a target lesion treatment success rate of 54% for erythema, 68% for plaque elevation, and 64% for scaling, she said.
The treatment discontinuation rate was 3.4% in the IDP-118 group, 12.1% with tazarotene, zero for halobetasol propionate, and 3.2% for vehicle. The most frequently reported treatment-emergent adverse events were mild or moderate application-site reactions. Skin atrophy was rare. No treatment-related serious adverse events occurred.
A 555-patient, phase III, open-label, 12-month safety study of IDP-118 is due to be completed later in 2017.
The phase II study was funded by Valeant Pharmaceuticals. Dr. Stein Gold reported serving as an investigator, advisor, and speaker for the company. SDEF and this news organization are owned by the same parent company.