Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for Moderate-to-Severe Psoriasis: Pooled Phase 3 Analysis of Lower Extremities

April 2020 | Volume 19 | Issue 4 | Original Article | 389 | Copyright © April 2020

Published online March 20, 2020

Stephen Tyring , Leon H. Kircik , Paul Yamauchi , Abby Jacobson , Tina Lin

aUniversity of Texas Health Science Center, Houston, TX bIndiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, Louisville, KY; and Icahn School of Medicine at Mount Sinai, New York, NY cDermatology Institute & Skin Care Center, Inc., Santa Monica, CA dOrtho Dermatologics,* Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC.

similar among HP/TAZ and vehicle lotion groups (Table 1). Participants in both treatment groups at baseline had a mean (SD) overall BSA of 5.6% (2.6%). Mean (SD) leg lesion (target) area in HP/TAZ and vehicle lotion groups was 39.8 (24.2) cm2 and 45.0 (24.9) cm2, respectively. At baseline, >80% of participants in both treatment groups had signs of psoriasis (erythema, plaque elevation, scaling) that were categorized as mild or moderate in severity; >80% also had a moderate IGA score.

Efficacy Evaluations
At the end of the 8-week treatment period, a significantly greater proportion of participants receiving HP/TAZ lotion achieved treatment success at the target lesion (leg), with 41.6%, 58.5%, and 59.5% achieving a ≥2-grade reduction in erythema, plaque elevation, and scaling severity on the leg, compared with 12.5%, 19.2%, and 21.0% of those treated with vehicle, respectively (P<0.001 all; Figure 2). Therapeutic effects of HP/TAZ lotion were sustained through week 12, with treatment success in 44.6% (erythema), 53.2% (plaque elevation), and 54.4% (scaling) of HP/TAZ-treated participants versus 17.3%, 27.9%, and 26.0%, respectively, of those in the vehicle-treated group (P<0.01 all). Significant differences versus vehicle were observed by week 2