Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion With a Ceramide-Containing Moisturizer in Adults With Psoriasis

February 2024 | Volume 23 | Issue 2 | 50 | Copyright © February 2024


Published online January 30, 2024

Leon Kircik MDa, Abby Jacobson PA-Cb

aDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY 
bMedical Affairs, Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ

Abstract
Introduction: Moisturizers are often used as adjuvant therapy for psoriasis to assist with rehydration and skin barrier restoration. Fixed-combination halobetasol propionate 0.01% and tazarotene 0.045% lotion (HP/TAZ) is indicated for the topical treatment of plaque psoriasis in adults, with a demonstrated clinical profile in two phase 3 trials. However, the effect of application order with HP/TAZ has yet to be explored. This study evaluated the clinical profile of HP/TAZ applied before versus after a ceramide-containing moisturizer in adults with mild-to-moderate plaque psoriasis.
Methods: Sixteen participants were randomized to apply HP/TAZ followed by moisturizer on one side and moisturizer followed by HP/TAZ on the other side once daily for 12 weeks. Tolerability, safety, efficacy, and quality of life endpoints were assessed. 
Results: Significant Investigator's Global Assessment improvement was observed across all time points (P≤0.003) regardless of application order. Total Dermatology Life Quality Index scores significantly improved at all time points (P≤0.003), and visual analog scale for itch significantly improved at weeks 4, 8, and 12 (P<0.008). Four moderate adverse events were experienced by 3 participants. Two participants reported itching/irritation, which was worse when HP/TAZ was applied first.
Conclusions: The application order of moisturizer did not decrease therapeutic efficacy of HP/TAZ. Moisturizer application before HP/TAZ may reduce incidence of application site adverse events, ultimately increasing tolerability and supporting the real-world recommendation that applying a ceramide-containing moisturizer before HP/TAZ, versus after, results in a safe and effective therapeutic option for plaque psoriasis.

J Drugs Dermatol. 2024;23(2):50-53.     doi:10.36849/JDD.7928

INTRODUCTION

Psoriasis, a chronic inflammatory disease characterized by erythematous and scaly skin, is caused by hyperproliferation and differentiation of keratinocytes, which results in dysregulation of the skin barrier.1,2 Typically, a healthy stratum corneum consists of corneocytes and a lipid-rich extracellular matrix organized in a brick-and-mortar arrangement.3 Ceramides, cholesterol, and free fatty acids predominantly populate the extracellular matrix and contribute to maintenance of barrier homeostasis and hydration.4,5 However, in patients with psoriasis, the stratum corneum becomes depleted of lipids, including ceramides, resulting in disrupted skin barrier function, elevated levels of transepidermal water loss (TEWL), and reduced stratum corneum hydration.2,5,6 Notably, depletion of stratum corneum lipids in psoriasis is thought to be limited to lesional epidermis and may potentiate inflammation associated with psoriasis.5,7

As such, direct restoration of the skin barrier is crucial for patients with psoriasis and may be facilitated by using moisturizers. Some moisturizers (eg, emollients) promote retention of hydration in the stratum corneum, reduce  TEWL, and normalize hyperproliferation and differentiation of keratinocytes, thereby supporting skin barrier function in patients with psoriasis.8 Furthermore, moisturizers that contain lipids such as ceramides may further assist in skin barrier repair by supplementing the aforementioned "mortar" of the stratum corneum and increasing total skin ceramide content.5,9 Indeed, the American Academy of Dermatology and National Psoriasis Foundation joint guidelines recommend the use of moisturizers (ie, creams, ointments, lotions, and gels) as adjuvant therapy for topical corticosteroids to help reduce itch and desquamation.8 Despite the widespread use of moisturizers in psoriasis regimens, there is still a need to evaluate the order of application with moisturizers and prescription therapies regardless of the therapeutic agent selected.10-13