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.






with an IGAxBSA-50 achievement was also significantly greater among HP/TAZ-treated participants than those treated with vehicle (58.1% vs 26.3%, respectively; P<0.001).

Safety Evaluations
Of the participants treated with HP/TAZ lotion, 36.1% reported treatment-emergent AEs (TEAEs) compared with 22.9% of those treated with vehicle; TEAEs were categorized as mild or moderate in severity in most patients (Table 2). Only 3 participants (2.1%) reported serious AEs following treatment with HP/TAZ lotion. The most common treatment-related TEAEs (incidence ≥2%) in HP/TAZ-treated participants were contact dermatitis (7.6%), skin atrophy (2.8%), folliculitis (2.8%), and excoriation (2.1%); no AEs of striae were identified. In the 4 patients with a TEAE of skin atrophy, all cases were mild or moderate in severity and were resolved/resolving with either a dose reduction or no change in treatment. In the vehicle-group, frequently reported treatment-related TEAEs were pruritus, skin burning sensation, and burning sensation (nervous system disorder; 2.9% for all).

DISCUSSION

This pooled post hoc analysis of 2 phase 3 studies evaluated the efficacy and safety of HP/TAZ lotion in patients with moderate to severe plaque psoriasis of the lower extremities (target lesion of the leg). At the end of the 8-week treatment period, HP/TAZ lotion demonstrated significant efficacy in improving signs of psoriasis (erythema, plaque elevation, and scaling) at the leg target le-