Topical 0.25% desoximetasone spray efficacy for moderate to severe plaque psoriasis: a randomized clinical trial

Abstract

Background: Traditionally, ointments were the vehicle of choice for psoriasis. Poor adherence of traditional vehicles limits the use of topical corticosteroids. Alternative formulations have gained popularity due to their ease of application, improved adherence and efficacy.

Objective: To evaluate the efficacy of topical desoximetasone 0.25% spray formulation in extensive psoriasis.

Methods: This multicenter, double-blinded, randomized trial compared twice daily topical 0.25% desoximetasone spray to placebo in subjects ≥18 with moderate to severe plaque psoriasis. Primary outcome of the study was the proportion of subjects in each group that achieved clinical success (Physician Global Assessment [PGA] of 0 or 1) and/or treatment success at (target lesion score of 0 or 1) day 28.

Results: One-hundred-and-twenty subjects were enrolled. At baseline, 75.0% and 73.3% of the treatment and placebo group had at least moderate PGA, respectively. Clinical success in the intended-to treat and placebo group was 30% and 5% (p = .0003), respectively; treatment success was 39% and 7% (p < .0001), respectively.

Limitations: The lack of standardized outcomes for topical psoriasis treatments limits the ability to compare the results to other treatments.

Conclusions: Topical desoximetasone spray provides rapid control of moderate to severe psoriasis lesions and may be considered for patients awaiting approval of biologicals.

Trial registration: ClinicalTrial.gov identifier: NCT01206387.

Keywords:

• Psoriasis
• topical steroid
• adherence
• clinical trial
• steroid spray

Disclosure statement

The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories. L.P. Dr. Feldman is a speaker for Janssen and Taro. He has received research, speaking and/or consulting support from a variety of companies including Galderma, GSK/Stiefel, Almirall, Leo Pharma, Baxter, Boeringer Ingelheim, Mylan, Celgene, Pfizer, Valeant, Abbvie, Cosmederm, Anacor, Astellas, Janssen, Lilly, Merck, Merz, Novartis, Qurient, National Biological Corporation, Caremark, Advance Medical, Suncare Research, Informa, UpToDate and National Psoriasis Foundation. He is the founder and majority owner of www.DrScore.com. He is founder and part owner of Causa Research, a company dedicated to enhancing patients’ adherence to treatment. Mohammed D. Saleem and Deborah Negus have no conflicts to disclose.

Additional information

Funding

This study was funded by Taro Pharmaceuticals.