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 3
Clinical Success at Day 28 based on PGA score. The following definitions were used to determine treatment outcome:
Clinical Success PGA score of 0 (clear) or 1 (almost clear)
Clinical Failure PGA score >1 or insufficient therapeutic response
An insufficient therapeutic response was recorded if the investigator noted worsening of psoriasis in a subject at any time during the study or if a subject did not complete the study because of lack of treatment effect, including being provided an alternative medication or therapy for treatment of the psoriasis.
The primary endpoint based on TLSS was the proportion of subjects in each treatment group who were considered a Treatment Success for the target lesion at Day 28. The following definitions were used to determine the treatment outcome, with insufficient therapeutic response recorded as noted above for PGA:
Treatment Success TLSS of 0 (clear) or 1 (almost clear) for each of three individual signs: erythema, scaling, and plaque elevation
Treatment Failure TLSS >1 for any of the individual signs or insufficient therapeutic response