27611 Fixed-combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion for the treatment of plaque psoriasis in patients with 3-5% body surface area (BSA) and poor quality of life (QoL)

Document Type

Conference Proceeding

Publication Date


Publication Title

Journal of the American Academy of Dermatology


Use of TAZ with topical steroids, such as superpotent HP, is recommended for mild-to-moderate psoriasis as the combination may provide synergistic efficacy while increasing duration of treatment effect and remission. The objective of this analysis was to investigate HP 0.01%/TAZ 0.045% lotion in patients with relatively low affected BSA and poor QoL, as objective measures such as BSA may underestimate disease severity. Two phase 3, multicenter, double-blind studies enrolled 418 adults with 3-12% BSA and Investigator’s Global Assessment (IGA) score of 3 or 4 (‘moderate’ or ‘severe’) at baseline. Participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks, with a 4-week posttreatment follow-up. Pooled, post hoc analyses were conducted in a subset of 65 participants with baseline BSA of 3-5% and Dermatology Life Quality Index (DLQI) score ≥11. At week 8, 50.3% of HP/TAZ-treated participants achieved treatment success (≥2-grade reduction from baseline in IGA and score of 0 or 1 [‘clear’ or ‘almost clear’]), vs 14.6% of vehicle-treated participants (P ˂.05). BSA was significantly reduced with HP/TAZ ( 39.2%) vs vehicle lotion (+15.9%; P ˂.05). The percentage of participants experiencing a clinically meaningful ≥4-point reduction in DLQI score was greater for HP/TAZ (85.3%) vs vehicle (55.6%). Numerical improvements with HP/TAZ lotion were maintained 4-weeks posttreatment for efficacy measures and DLQI, consistent with the overall population. Though analyses were limited by the small population, HP/TAZ lotion provided significantly greater efficacy vs vehicle in participants with low BSA and poor QoL, with clinically relevant improvements in QoL.







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