Clinical Study Results of Desoximetasone Spray, 0.25% in Moderate to Severe Plaque Psoriasis

December 2013 | Volume 12 | Issue 12 | Original Article | 1404 | Copyright © December 2013

Leon Kircik MD,a,b,c Mark G. Lebwohl MD,c James Q. Del Rosso DO,d
Jerry Bagel MD,eLinda Stein Gold MD,f Jonathan S. Weiss MDg

aDepartment of Dermatology, Indiana University School of Medicine, Indianapolis, IN
bPhysicians Skin Care, PLLC, Louisville, KY
cDepartment of Dermatology, Mount Sinai School of Medicine, New York, New York
dDepartment of Dermatology, Touro University College of Osteopathic Medicine, Henderson, NV
ePsoriasis Treatment Center of Central New Jersey, East Windsor, NJ
fDirector of Dermatology, Clinical Research and Division Head of Dermatology, Henry Ford Health System, Detroit and West Bloomfield, Michigan
gGwinnett Clinical Research Center, Snellville, Georgia

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with psoriasis or atopic dermatitis. Topical desoximetasone formulations, which include both mid-potency and high potency TCS products depending on concentration and vehicle, are approved in over fifty countries in Europe, Asia, South America, and Africa.2,3In April 2013, desoximetasone spray 0.25% received FDA approval for the treatment of plaque psoriasis in adults (>=18 years of age), and is the first super-potency TCS formulation of desoximetasone.4,5
As the role of topical corticosteroid (TCS) therapy in the treatment of several cutaneous disorders became better defined over time, a variety of compounds and vehicle formulations emerged.3,5,6 These CS developed for topical use are specifically glucocorticosteroids based on the central structural nucleus of hydrocortisone, or derivatives thereafter such dexamethasone.3,5,6 Since its introduction in 1977 of desoximetasone 0.25% cream, subsequent formulations including 0.05% cream, gel and ointment have been approved. While the previous 0.25% formulations of desoximetasone are ranked as high-potency TCS, the. 0.05% formulations are ranked as mid-potency TCS.
Desoximetasone spray was formulated using a combination of ingredients designed to enhance cutaneous penetration (isopropyl myristate, isopropyl alcohol), to mitigate damage to the stratum corneum permeability barrier and provide emolliency (glyceryloleate, mineral oil), and reduce symptoms of irritation (l-menthol).4,5 Importantly, prior to the approval of the 0.25% spray, desoximetasone has never been formulated to provide the potency required to achieve the designation of super-potent TCS.

Desoximetasone Spray 0.25% Phase 1 and 2 Studies

Four pharmacologic studies were completed to support the approval of desoximetasone spray 0.25%. A phase I vasoconstrictor assay study was completed in healthy volunteers and demonstrated that this formulation achieved super-high potency status.2 It was also demonstrated that desoximetasone spray 0.25% does not induce photoallergy or phototoxicity, is not sensitizing, and has low potential for causing skin irritation in three additional Phase I studies. The negligible potential for inducing skin allergenicity is supported by the fact that desoximetasone is a Class C CS which exhibits the lowest potential for causing cutaneous allergy among all structural classes of TCS, calculated to be <0.2%.7,8
A phase 2 study evaluated the effects of desoximetasone spray 0.25% on hypothalamic-pituitary axis (HPA) suppression in 24 adult subjects treated twice daily for 28 days.4,5 Evaluable cortisol levels were present in 21 subjects. Evidence of HPA suppression was noted in 8.3% (1/12) of subjects with 10- 15% BSA and in 22.2% (2/9) of subjects with >15% BSA. In two subjects available for follow up testing, HPA suppression reversed within 28 days after the end of treatment.5 Plasma levels of desoximetasone were also measured in this latter study and were consistent with the low levels measured for the cream and ointment formulations.4