Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis
This investigator-blinded study is designed to assess whether the order of application affects the efficacy of the combination treatment Clobex® Spray (clobetasol propionate) and Vecitcal® (calcitriol) Ointment in plaque psoriasis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Spray® and Vectical Ointment® in the Treatment of Plaque Psoriasis|
- improvement in target lesion severity score (TLSS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: vectical ointment and clobex spray
patients were assigned to apply vectical ointment first then clobex spray on one target lesion and also apply clobex spray first then vectical ointment on a different target lesion on the opposite side of the body.
Drug: Calcitriol ointment
Other Name: Vectical OintmentDrug: Clobetasol spray
Other Name: Clobex spray
This is an investigator-blinded, bilateral comparison study. A total of up to 12 subjects with mild to moderate plaque psoriasis will be enrolled in this study, so that at least 10 subjects complete the 4 week trial. These 12 subjects will receive the combination therapy of Clobex® Spray and Vectical® Ointment to treat their psoriatic lesions (except those on the scalp, face, groin, axillae or other intertriginous areas). Half of the subjects will first apply the Clobex® Spray followed by the Vectical ointment to lesions on the right side of their bodies, and Vectical® Ointment first followed by Clobex® Spray to the lesions of the left side of their bodies. The other half of the subjects will first apply Clobex® Spray followed by Vectical® Ointment to the lesions of the left side of their bodies, and Vectical® Ointment first followed by Clobex® Spray to the lesions on right side of their bodies. Treatment will be applied twice daily for 4 weeks. One target area on each side of the subject's body will be chosen for target lesion assessment.
All subjects will be consented prior to any study evaluations/procedures. Study evaluations including Target Lesion Severity Score (TLSS) and photography will be performed at Baseline/Day 0, week 2 and week 4.
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Jason J Emer, MD||Mount Sinai School of Medicine|