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

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.

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