Investigational Psoriasis Topical Shows Promise in Clinical Trials
Findings from 2 phase 3 clinical trials demonstrate that halobetasol propionate and tazarotene (HP/TAZ) fixed combination lotion (Duobrii) may provide a realistic topical option for plaque psoriasis management, according to Gold and colleagues. The results were published in the Journal of the American Academy of Dermatology.
The 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 trials included a total of 418 participants with psoriasis with an Investigator’s Global Assessment (IGA) score of 3 or 4 and affected Body Surface Area (BSA) from 3% to 12%. Participants were randomized to once-daily HP/TAZ lotion or vehicle for 8 weeks and followed for 4 weeks after discontinuing treatment. Treatment success, defined as the percentage of participants who showed at least a grade 2 improvement in IGA scores compared with baseline and with “clear” or “almost clear” skin, was assessed as the main efficacy endpoint. In addition, the researchers evaluated safety and treatment-emergent adverse events.
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HP/TAZ lotion was more efficacious at achieving treatment success compared with vehicle, with statistically significant superiority demonstrated by week 4 in study 1 and by week 2 in study 2. By week 8, 35.8% and 45.3% of participants who received HP/TAZ lotion in study 1 and 2, respectively, achieved treatment success compared with 7% and 12.5% of participants who received vehicle. In addition, treatment success was maintained by the majority of participants throughout follow-up.
Additionally, HP/TAZ lotion was superior at reducing psoriasis signs and symptoms, affected BSA, and showed significant reductions in severity of clinical psoriasis signs compared with vehicle.
Contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%) were the most common treatment-related adverse events.
Gold LS, Lebwohl MG, Sugarman JL, et al. Safety and efficacy of a halobetasol/tazarotene fixed combination in the treatment of moderate-to-severe plaque psoriasis: results of two phase 3 randomized controlled trials [published online March 31, 2018]. J Am Acad Dermatol. https://doi.org/10.1016/j.jaad.2018.03.040.