A fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion to treat moderate to severe psoriasis is more effective than its individual active ingredients and is associated with rapid and significant changes in disease severity, according to study results published in Journal of Drugs in Dermatology.
The investigators of this study sought to determine the effectiveness of a unique fixed-combination HP/TAZ lotion for treating moderate to severe plaque psoriasis using validated alternative tools for measuring improvement in psoriasis severity.
The study included 212 patients with moderate to severe plaque psoriasis in a post hoc analysis; participants were randomly assigned 2:2:2:1 to receive HP/TAZ lotion, individual active ingredients (HP or TAZ), or vehicle only. Participants applied treatment once daily for 8 weeks and were followed for 4 weeks post-treatment.
The investigators used a composite Investigator Global Assessment and Body Surface Area (IGAxBSA) tool to assess efficacy outcomes, specifically changes in erythema, plaque elevation, and scaling from baseline to week 12. The primary study end point was mean change in IGAxBSA composite scores; additional end points were the time required to achieve 25% and 50% reduction in mean baseline IGAxBSA composite scores and the proportion of patients achieving ≥75% reduction in mean baseline IGAxBSA composite scores.
The study results showed HP/TAZ lotion was significantly superior to HP, TAZ, and vehicle at week 12 for reducing psoriasis symptoms. By week 8, participants treated with HP/TAZ lotion achieved a greater reduction in mean IGAxBSA composite scores vs participants treated with HP (63.5% vs 49.2%; P =.056), TAZ (63.5% vs 15.2%; P <.001) or vehicle alone (63.5% vs 11.9%; P <.001); this was sustained throughout the 4-week post-treatment follow-up period vs TAZ and vehicle (P <.001) and vs HP (P =.003).
Using HP/TAZ lotion, a 25% improvement in mean IGAxBSA composite scores was achieved within 1.9 weeks, and a 50% improvement in scores was achieved within 4.6 weeks. Participants receiving other treatment achieved a 25% reduction in scores within 3 weeks, and did not achieve a 50% reduction in scores over the course of the study. Of the sample treated with HP/TAZ lotion, 47.5% achieved ≥75% reduction in mean baseline IGAxBSA composite scores by week 8, which was sustained for 4 weeks following the treatment period.
Limitations to the study included a small sample size that only included patients with moderate to severe psoriasis with a baseline IGA score of ≥3 and baseline BSA involvement of 3% to 12%.
Fixed-combination HP/TAZ lotion to manage moderate to severe plaque psoriasis was effective and superior to individual active ingredients; HP/TAZ lotion was associated with significant and rapid improvement of psoriasis indicated by a 63.5% reduction in mean baseline IGAxBSA composite scores. The investigators suggest that the addition of tazarotene to the fixed combination importantly helped sustain post-treatment benefit.
Stein Gold L, Bagel J, Lebwohl MG, Lin T, Martin G, Pillai R. Halobetasol and tazarotene: further defining the role of a unique fixed combination topical lotion in moderate-to-severe plaque psoriasis. J Drugs Dermatol. 2018;17(12):1290-1296.