This is a multi-center, randomized, double-blind, bilateral comparison study evaluating the safety and efficacy of RP 73401 (piclamilast) 0.5% ointment vs. its vehicle in adults with psoriasis who are at least 18 years of age. As a control, a subgroup of patients will receive Synalar (flucoinolone acetonide) 0.025% ointment (to one side) vs. the ointment vehicle (to the other side of the body). Randomization of patients into the RP73401/vehicle group and Synalar/vehicle subgroup will be in a ratio of 2:1. Patients will be treated twice daily on the designated target areas for 21 days. The investigators will enroll a maximum number of 45 patients (15 per site) to ensure sufficient patients to ensure that data from at least 30 patients will be evaluable for efficacy and safety analyses. The safety and efficacy of the RP 73401 (piclamilast) 0.5% ointment will be evaluated by observing the incidence and severity of adverse experiences (local and systemic). Changes in routine laboratory values will be measured at the last visit and compared to the baseline values. The treatment effects of piclamilast will be assessed by evaluation of individual and total key disease signs/symptom scores, overall change in disease status.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000102-35S1
Application #
6115892
Study Section
Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
35
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Rockefeller University
Department
Type
DUNS #
071037113
City
New York
State
NY
Country
United States
Zip Code
10065
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