An Investigator-Initiated Trial of a Polymeric Emulsion of Halobetasol Propionate and Tazarotene in the Treatment of Palmoplantar Psoriasis

February 2023 | Volume 22 | Issue 2 | 223 | Copyright © February 2023


Published online January 30, 2023

doi:10.36849/JDD.7067

Jenna Yousif BSa, Folawiyo Babalola BSAb, Caroline R. Campbell MDa, Alice B. Gottlieb MD PhDa, Jessica Vargas a, Krystal Mitchell MD MBAa

aDepartment of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, NY
bJoe R. & Teresa Lozano Long School of Medicine at the University of Texas Health Science Center at San Antonio, San Antonio, TX

Abstract
Copy: Palmoplantar psoriasis is a chronic, difficult-to-treat localized variant of psoriasis that affects the palms and soles, significantly affecting patient's quality of life.
Objective: To evaluate the synergistic effect of a fixed-combination topical lotion composed of halobetasol propionate 0.01% and tazarotene 0.045% in the treatment of palmoplantar psoriasis.
Methods: This was an open-label investigator-initiated trial involving 21 patients with moderate-to-severe palmoplantar plaque-type psoriasis who underwent treatment with halobetasol propionate 0.01% and tazarotene 0.045%. Subjects were assessed for disease severity using the palmoplantar Physician Global Assessment and the mean difference over time was compared using the Wilcoxon signed-rank test.
Results: 5 patients (24%) achieved a palmoplantar Physician Global Assessment of 0 or 1 after week 24 or last observation carried forward. The mean palmoplantar Physician Global Assessment significantly decreased from baseline (3.57) to week 24/last observation carried forward (2.38) (P<0.001).
Discussion: Halobetasol propionate 0.01% and tazarotene 0.045% lotion demonstrated efficacy in adult patients with moderate-to-severe palmoplantar plaque-type psoriasis through significant improvement in palmoplantar Physician Global Assessment. The complementary mechanisms of action of the corticosteroid and tazarotene may be of benefit compared to monotherapeutic agents.

Citation: Yousif J, Babalola F, Campbell CR, et al. An investigator-initiated trial of polymeric emulsion of halobetasol propionate and tazarotene in the treatment of palmoplantar psoriasis. J Drugs Dermatol. 2023;22(2):218-220. doi:10.36849/JDD.7067

INTRODUCTION

Palmoplantar psoriasis is a chronic, localized form of psoriasis affecting the palms and soles and is prevalent in 3-4% of individuals with psoriasis.1 Although there has been no standard therapeutic treatment, potent to super-potent topical corticosteroids, tazarotene (TAZ), and vitamin D analogues are commonly the first-line agents.1,2 However, as monotherapy, these agents do not properly penetrate the thickened stratum corneum, often resulting in treatment failure.2 As a result, the objective of this study was to evaluate the synergistic effect of an FDA approved fixed-combination topical lotion composed of the mid-to-high potency corticosteroid halobetasol propionate (HP) 0.01% and the retinoid TAZ 0.045% (HP/TAZ; Duobrii®) on improving the signs and symptoms of palmoplantar plaque type psoriasis.

MATERIALS AND METHODS

Patients aged 18 years or older with moderate-to-severe plaque-type psoriasis, as determined by a score of ≥3 on the palmoplantar Physician Global Assessment (ppPGA) scale were eligible to participate in this open-label study.3 ppPGA scores include 0 (clear), 1 (almost clear/minimal), 2 (mild), 3 (moderate), 4 (marked/moderate-to-severe), and 5 (severe).3

Subjects applied a thin layer of HP/TAZ lotion once daily to affected areas for 24 weeks. Subjects were assessed for disease severity using the ppPGA at 0, 2, 8, 12, 16, and 24 weeks and treatment satisfaction using a previously published numerical rating scale.4 Photography of the hands and/or feet were taken to assess for treatment response. Safety and treatment-related adverse events were evaluated throughout the study.

The difference between Baseline (week 0) and week 24/Last Observation Carried Forward (LOCF) was assessed with the Wilcoxon signed-rank test. Alpha risk was set to 5% (α = 0.05). Statistical analysis was performed with EasyMedStat (version 3.14; www.easymedstat.com).
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