Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT01205880|
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : September 21, 2010
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Calcitriol ointment Drug: Clobetasol spray||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Official Title:||Spray® and Vectical Ointment® in the Treatment of Plaque Psoriasis|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- improvement in target lesion severity score (TLSS) [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205880
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Jason J Emer, MD||Icahn School of Medicine at Mount Sinai|