Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies

J Drugs Dermatol. 2018 Aug 1;17(8):855-861.

Abstract

Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns.

Objective: Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.

Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment emergent AEs evaluated throughout.

Results: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).

Limitations: No data were collected beyond the 4-week follow-up.

Conclusions: HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

Publication types

  • Meta-Analysis

MeSH terms

  • Clinical Trials, Phase III as Topic / methods*
  • Clobetasol / administration & dosage
  • Clobetasol / adverse effects
  • Clobetasol / analogs & derivatives*
  • Dermatitis / diagnosis
  • Dermatitis / etiology
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Multicenter Studies as Topic / methods
  • Nicotinic Acids / administration & dosage*
  • Nicotinic Acids / adverse effects
  • Pain / chemically induced
  • Pain / diagnosis
  • Psoriasis / diagnosis
  • Psoriasis / drug therapy*
  • Psoriasis / epidemiology
  • Randomized Controlled Trials as Topic / methods
  • Severity of Illness Index
  • Skin Cream / administration & dosage*
  • Skin Cream / adverse effects
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Drug Combinations
  • Nicotinic Acids
  • tazarotene
  • halobetasol
  • Clobetasol