Safety and Efficacy Study of A Novel Ointment to Treat Plaque Type Psoriasis
The purpose of the study is to determine the safety and efficacy of AN2728 Ointment, 5%, compared to Ointment Vehicle in the treatment of plaque type psoriasis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Randomized Bilateral Study of the Safety and Efficacy of AN2728 Ointment, 5%, Versus Ointment Vehicle in the Treatment of Patients With Plaque Type Psoriasis|
- Overall Target Plaque Severity Assessment (OTPSS) at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
- Change of Overall Target Plaque Severity Score and erythema, scaling and plaque elevation assessments from baseline [ Time Frame: Days 7, 14, 21, 28 and 35 ] [ Designated as safety issue: No ]
- Overall Target Plaque Severity Assessment (OTPSS) at Days 7, 14, 21 and 35 [ Time Frame: Days 7, 14, 21 and 35 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
AN2728 Ointment, 5%
AN2728 Ointment, 5%, twice daily for 4 weeks
Other Name: AN2728 Ointment, 5%
Placebo Comparator: 2
AN2728 Ointment Vehicle
Drug: AN2728 Ointment Vehicle
AN2728 Ointment Vehicle, twice daily for 4 weeks.
Other Name: AN2728 Ointment Vehicle
This is a multi-center, randomized, double-blind bilateral design. Patients will apply the test articles, AN2728 Ointment, 5%, and Ointment Vehicle twice daily. The assigned study medication will be applied to two comparable treatment targeted plaques identified at baseline. One test article will be applied to one plaque and the other test article to an anatomically distinct plaque. All efficacy evaluations will be measured from only the two plaques identified at the baseline visit.