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

table 4
According to the Statistical Analysis Plan (SAP) for each study, the primary and secondary efficacy analyses were to be based on an intent-to-treat (ITT) population, defined as subjects who were exposed to study medication. Subjects who withdrew for lack of effect were to be considered a Clinical Failure or Treatment Failure regardless of their PGA or target lesion scores at the last visit. Those who withdrew from either study for reasons other than lack of effect were to be retained in the ITT population and analyzed with the LOCF. Interim missing data were excluded from analyses with no imputation.
The primary efficacy variables, as defined prospectively in the protocols, were Clinical Success and Treatment Success based on the PGA score and the TLSS, respectively.

Primary and Secondary Efficacy Results

In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28 (Figures 1 and 2). These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion).
Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily (Table 4).

Safety and Tolerability Results

Tolerability and safety were assessed at all study visits. In one study which included a total of 120 subjects, 38 subjects reported a total of 69 adverse events (AEs), with 35 AEs noted in the active treatment group, and 34 reported by subjects in the vehicle group.2 Among the 120 study subjects in the other pivotal study, 21 subjects reported a total of 34 adverse events. Of these events, 16 were reported by actively treated subjects and 18 were noted by vehicle-treated subjects.42 Some of these AEs were determined to be unrelated to study medication, while others, especially application site reactions, were often determined as possibly, probably, or definitely related to study treatment.
Detailed summaries of AEs are from the Phase 3 studies are depicted in Tables 5-6.4,5 No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging or burning was reported in any subject throughout the study.
A total of 24 subjects discontinued from the two Phase 3 studies. Overall, comparable proportions of subjects discontinued from the both the active and vehicle groups within each study and across both studies. Overall, three subjects withdrew for insufficient therapeutic response and were considered a Clinical Failure or Treatment Failure regardless of their PGA or target lesion scores at the last visit. Two subjects who ran out of study medication had BSA values of 14% and 30% at Baseline.


Desoximetasone spray 0.25% used twice daily for 28 days proved to be effective and safe for the treatment of adults with moderate to severe plaque psoriasis. The % BSA required for inclusion was markedly higher in this study than in other studies of super-potent TCS agents. In both Phase 3 studies with desoximetasone spray 0.25%, the inclusion criteria mandated >=10% BSA, with the mean % BSA at baseline (study entry) ranging from 15.58%-17.78%.