A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation
October 2017 | Volume 16 | Issue 10 | Original Article | 972 | Copyright © 2017
Elias Oussedik BS,a Mohammed D. Saleem MD,a Steven R. Feldman MD PhDa,b,c
aCenter for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC bDepartment of Pathology, Wake Forest School of Medicine, Winston-Salem, NC cDepartment of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC
BACKGROUND: Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of desoximetasone spray is not fully characterized. OBJECTIVE: To evaluate the relative vasoconstrictive potency of desoximetasone 0.25% topical spray formulation. METHODS: This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device. RESULTS: Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported. Limitations: The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to desoximetasone spray. CONCLUSIONS: Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice.
J Drugs Dermatol. 2017;16(10):972-975.
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Topical corticosteroids are the most common pharmacological agents used in the treatment of dermatological conditions.1 Traditionally, ointments have been the preferred choice for dry scaly conditions due to their high relative potency compared to creams or lotions and ability to moisturize dry conditions like eczema and psoriasis.2 However, ointments are often viewed as messy and time-consuming to apply, which are barriers to adherence and to good treatment outcomes.3 Spray formulations are preferred by patients due to their ease of application and proven efficacy. The potency of the newly designed desoximetasone 0.25% topical spray is not yet well characterized. The purpose of this study is to evaluate the vasoconstrictive potency of desoximetasone 0.25% topical spray formulation.
MATERIALS AND METHODS
Enrolled participants were healthy non-tobacco using male and female subjects between the ages of 18 and 50 years of age with body mass index of 30 kg/m2 or less. All subjects were pre-screened to show a vasoconstrictor response to 0.05% uticasone propionate cream. Ten microliters (10 μl) was applied to the upper forearm and was left in place for 1 hour (±15 minutes), and visually evaluated 6-9 hours after application. All subjects were selected based on a demonstrated blanching response (at least a 1 on 0-3 rating scale). Subjects were excluded if they had a history of allergy to any systemic or topical corticosteroid, had used a topical dermatological drug therapy on the ventral forearms 30 days prior to the study, or were pregnant or lactating. Subjects with a history of chronic infectious disease, system disorder, organ dysfunction, drug or alcohol addiction requiring treatment in the 12 months prior to dosing, or had receipt of an investigational drug as part of a research study within 30 days prior to initial study, were also all excluded. All subjects provided written informed consent before study commencement.