Topical Desoximetasone 0.25% Spray and Its Vehicle Have Little Potential for Irritation or Sensitization
August 2017 | Volume 16 | Issue 8 | Original Article | 755 | Copyright © August 2017
Anish Nadkarni BS, Mohammed D. Saleem MD, and Steven R. Feldman MD PhD
Wake Forest School of Medicine, Winston-Salem, NC
Abstract
BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.
OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation.
METHODS: A multicenter, double-blinded, randomized, controlled study assessed the irritancy and sensitization of 0.25% and 0.05% topical desoximetasone spray. Controls included vehicle, a positive control (0.1% sodium lauryl sulfate), negative control (0.9% saline), and an active comparator control (clobetasol spray). The primary outcome of the study was to evaluate the difference in mean cumulative irritation and potential sensitization response of desoximetasone 0.25% and 0.05% topical sprays.
RESULTS: Of the 297 enrolled, 269 completed the study per protocol for the irritation phase and 250 completed the protocol for the sensitization phase. At 22 days, desoximetasone 0.25 and 0.5% spray were less irritating than clobetasol 0.05% spray; mean irritation score difference of -0.46 and -0.57, respectively. Median total irritation score over the 22 days was 0 for all products. No subjects demonstrated any sensitization reaction to any of the six products. No serious adverse reactions were reported.
LIMITATIONS: Selection bias, use of a healthy population, limits the external validity. In addition, the duration of the study was short lived, unlike numerous inflammatory skin diseases.
Conclusions: Desoximetasone spray has little potential for irritation or sensitization. The availability of another spray option for patients desiring less messy treatment may facilitate better adherence and treatment outcomes.
J Drugs Dermatol. 2017;16(8):755-758.
INTRODUCTION
The most common dermatologic medications prescribed are topical corticosteroids. Irritation or hypersensitivity reactions can result from topical corticosteroid or their vehicles.1,2 The prevalence of contact sensitization ranges from approximately 0.5 to over 5%.3-6 In a postmarking FDA review including 202 cases, the frequency of local irritation to topical corticosteroids was 66%.7 While psoriasis used to be commonly treated with ointment preparations, spray formulations now offer patients less messy alternatives. Clobetasol and desoximetasone sprays are effective in the treatment of plaque type psoriasis and generally improve quality of life more than other topical vehicles.8,9 Ointments are messy, time-consuming to apply, and inconvenient to carry around. Spray formulations help address these issues, but irritation and sensitization could potentially limit their value. We evaluated the irritation and sensitization of desoximetasone (0.25%, 0.05%) topical spray in a randomized study comparing six products.
METHODS
This is a multicenter, 1:1:1:1:1:1 randomized, controlled study conducted in the United States (3 sites). Desoximetasone 0.25% and 0.05% topical sprays were compared to a positive control (0.1% sodium lauryl sulfate (SLS) solution), negative control (0.9% saline solution), clobetasol 0.05% spray, and placebo spray for potential cumulative skin irritation and sensitization. The design was based on previous irritation and sensitization studies approved by the FDA. The study was reviewed and approved by the FDA under the investigational new drug application 101,789. It followed Good Clinical Practice- the protocol, and consent forms were reviewed and approved the by Independent Review Board (IRB). All subjects were 18 years of age or older and in general good health. Those with a history of tricyclic antidepressants or CNS depressants within 6 months, allergy or sensitization to ingredients in the treatment arm formula or history of antihistamines or corticosteroid within 72 hours and 21 days respectively were excluded. Pregnant or lactating females were also excluded- testing was done on day 1 and 36. Prior to product application, all subjects were screened for alcohol, marijuana, and cocaine using urine/salvia testing on day 1 and 36; participants with positive test results were withdrawn from the study.
