Efficacy and Safety of Desoximetasone 0.25% Spray in Adult Atopic Dermatitis Subjects: Pilot Study

September 2017 | Volume 16 | Issue 9 | Original Article | 919 | Copyright © 2017

Lauren K. Hoffman BSa and Leon Kircik MDb

aAlbert Einstein College of Medicine, Bronx NY bMount Sinai Medical Center, New York, NY; Physicians Skin Care, PLLC, Louisville, KY

Abstract

BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder. One of the most disturbing symptoms of AD is pruritus. The first line treatment for AD is topical corticosteroids, topical immunomodulators, topical barrier creams, oral antihistamines, and systemic treatments. Desoximetasone 0.25% spray is a superpotent topical corticosteroid delivered in a novel way and it may be a suitable option for the treatment of pruritus in adult atopic dermatitis patients. STUDY DESIGN: A single-center, open labeled pilot study was conducted to investigate the efficacy and safety of desoximetasone 0.25% spray for pruritus in adult atopic dermatitis patients. RESULTS: Twice daily application of desoximetasone 0.25% spray to affected areas resulted in a significant reduction in all outcomes (IGA, pruritus, VAS assessment of pruritus) within 1 week of initiation of treatment. The reductions exhibited were sustained throughout the study period of 4 weeks. Significant improvements in quality of life, as measured by the DLQI, were observed. No adverse events were reported. CONCLUSION: Desoximetasone 0.25% spray is effective for treating pruritic symptoms of AD. Given its efficacy and convenience as a spray, desoximetasone 0.25% spray should continue to be evaluated as a treatment for AD in larger trials.

J Drugs Dermatol. 2017;16(9):919-922.

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INTRODUCTION

Atopic Dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder with a potentially large burden on quality of life. Pruritus is one of the most frustrating symptoms of AD, leading to decreased quality of life.1 Current treatments for pruritus associated with AD include: skin hydration with use of emollients and barrier creams, topical corticosteroids, topical immunomodulators, oral antihistamines, and systemic treatments.1-3 A variety of corticosteroid compounds and vehicles have emerged to enhance the efficacy and cutaneous penetration of the active molecule. Desoximetasone 0.25% spray has recently been approved for the treatment of plaque psoriasis in patients 18 years of age or older. The goal of this study was to investigate the efficacy and safety of desoximetasone 0.25% spray in assessing the pruritus of adult AD patients.

METHODS

Study DesignA single center, open label pilot study was conducted to investigate the efficacy and safety of desoximetasone 0.25% spray (TOPICORT® Spray, 0.25%, Taro Pharmaceuticals, Inc., Hawthorne, NY) for pruritus in adult patients with AD. Male or female subjects of any race, 18 years of age or older, with AD were potentially eligible for the study.To be enrolled in the study, subjects had to have a definitive diagnosis of atopic dermatitis as per the Rajka-Hanifin criteria, pruritus of at least 50 or more on the Visual Analogue Scale (VAS), and moderate atopic dermatitis (score of 3) on Investigator’s Global Assessment (IGA) Score at baseline (Table 1). Participants were required to be capable of providing informed consent and complying with study instructions.Key exclusion criteria included pregnancy, active or chronic skin allergies or skin disease, an uncontrolled chronic disease (ie, diabetes), recent use of investigational drugs or procedures, and current use of medication that could interfere with the study. The use of the following medications was prohibited during the trial and were washed out for an appropriate time period prior to starting treatment: tar or light treatment (UVA, UVB), cyclosporine or other oral systemic immunosuppressants, oral corticosteroids, inhaled or intranasal corticosteroids, topical medications (ie, corticosteroids, antihistamines, antimicrobials, immunomodulators, or other medicated topicals). Female subjects of childbearing potential had to have a negative urine pregnancy test at baseline and practice a reliable form of birth control during the trial period. Informed consent was obtained from all study participants and the study was performed in accordance with Good Clinical Practices, including guidelines outlined by the International Conference on Harmonisation.Treatment was provided in an open-label fashion at Baseline. Subjects were instructed to apply a thin layer of desoximetasone

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