An Open-Label Pilot Study to Investigate Safety and Efficacy of Fixed Combination Tazarotene 0.045% and Halobetasol Propionate 0.01% Lotion for the Treatment of Scalp Psoriasis

November 2021 | Volume 20 | Issue 11 | Original Article | 1191 | Copyright © November 2021


Published online October 18, 2021

Elif Ozyurekoglu a, Leon H. Kircik MDa

aIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University Medical Center, Indianapolis, IN; Physicians Skin Care, PLLC; DermResearch, PLLC; Skin Sciences, PLLC, Louisville, KY

Abstract
Up to 80% of individuals with plaque psoriasis have scalp involvement, which can have a significant impact on the quality of life of affected individuals. Despite advancements in psoriasis therapeutics, management of scalp involvement remains a challenge. This12-week, open-label pilot study assessed the safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of patients with mild-to-moderate plaque psoriasis with scalp involvement. Among 20 patients who were followed through 12 weeks, there were significant improvements in the primary endpoint (Investigator’s Global Assessment (IGA)) and most secondary endpoints (Psoriasis Scalp Severity Index (PSSI), body surface area (BSA), and scalp IGA (sIGA)). Treatment was well-tolerated. Further placebo-controlled double-blinded study for confirmation of our results is recommended.

J Drugs Dermatol. 2021;20(11): 1191-1194. doi:10.36849/JDD.0102

INTRODUCTION

Psoriasis is a common, chronic, autoimmune skin disorder that, in its plaque form, is characterized by dry, red lesions with silvery scales that cause itching, dryness, and irritation.1 About 80% of psoriasis patients have scalp involvement, which can be challenging to treat. Systemic therapies, including biologics, may improve scalp psoriasis, although there is limited head-to-head comparative data assessing the effectiveness of biologics for scalp disease.2,3 Additionally, not all patients are candidates for systemic therapy, and dermatology providers may not consider systemic therapy for patients with psoriasis limited primarily or exclusively to the scalp. Other treatments shown effective in the management of scalp psoriasis include phototherapy, topical medications, and even complementary and alternative medical interventions used to clear psoriasis or reduce symptoms; combination approaches are frequently employed.4-7 These psoriasis treatment methods have been used with limited to moderate results for scalp involvement due to challenges associated with application, potential adverse effects, and high costs.8,9 Topical products are difficult to use consistently to treat scalp psoriasis, especially due to hair on the affected area; application of topical medications can be arduous, messy, and inconvenient and can leave residue on the scalp and hair.5 Long-term adherence with inconvenient regimens may be limited, leading to poor response or frequent relapse.9,10 Importantly, it is recognized that scalp psoriasis can have a detrimental psychological impact upon patients, with many experiencing interpersonal stress and anxiety over displaying their symptoms publicly.11,12 Therefore, it is desirable to identify effective interventions for scalp psoriasis.

Fixed combination tazarotene 0.045% and halobetasol propionate 0.01% (Duobrii, Ortho Dermatologics) lotion has recently been approved for treatment of moderate-to-severe plaque type psoriasis. The lotion base is suggested to confer benefits for application to the hair-bearing scalp. A pilot study was completed to evaluate the efficacy and safety of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% for the treatment of moderate to severe plaque psoriasis with scalp involvement. There was significant improvement in the primary and most secondary endpoints, indicating that further study is warranted.

STUDY DESIGN

A single-center, open-label pilot study was designed to assess treatment with fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion in adult subjects (age 18 or older) with moderate-to-severe plaque type, as indicated by an Investigator’s Global Assessment (IGA) scale value of 3 or 4, with scalp involvement.