The purpose of this study is to evaluate the safety and efficacy of AN2728 Ointment B, 2.0% and 0.5%, compared to Ointment Vehicle B, applied once or twice daily for 12 weeks, in the treatment of plaque type psoriasis
This is a multicenter, randomized, double-blind, vehicle-controlled, bilateral design. Patients will apply both test article AN2728 Ointment B (0.5% or 2%), and Ointment B Vehicle twice daily for 12 weeks. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
Unnamed facility
Chihuahua City, Chihuahua, Mexico
Unnamed facility
Mexico City, D.f., Mexico
Unnamed facility
Zapopan, Jalisco, Mexico
Unnamed facility
Monterrey, Nuevo León, Mexico
Unnamed facility
San Luis Potosí City, San Luis Potosí, Mexico
Percentage of Participants With Greater Decrease In Overall Target Plaque Severity Score (OTPSS): Ointment (2% Twice Daily), Vehicle
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher score indicates more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (2% twice daily) treated plaque versus (vs.) vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (2% twice daily) treated plaque respectively at Day 42 are reported.
Time frame: Day 42
Percentage of Participants With Greater Decrease In OTPSS: Ointment (0.5 % Once Daily, 0.5% Twice Daily and 2% Once Daily), Vehicle
OTPSS is a scale to assess plaque severity. Each target plaque was scored by the investigator on severity scale ranging from 0 (no plaque) to 8 (very severe plaque), where higher scores indicated more severity of a plaque. In this outcome measure, percentage of participants with reduced OTPSS in ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque versus vehicle treated plaque and percentage of participants with reduced OTPSS in vehicle treated plaque versus ointment (0.5 % once daily, 0.5% twice daily and 2% once daily) treated plaque respectively at Day 42 are reported.
Time frame: Day 42
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