This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
409
Topical Foam containing active drug
Topical Foam containing no active drug
Site 14
Fort Smith, Arkansas, United States
Site 01
Hot Springs, Arkansas, United States
Percentage of Subjects Rated a "Treatment Success" Based on the Investigator's Global Assessment (IGA)
The IGA score is a static evaluation of the overall or "average" degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: Day 15
Percentage of Subjects Rated a "Treatment Success" for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)
Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or "average" degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee.
Time frame: Day 15
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Site 17
Encino, California, United States
Site 19
Denver, Colorado, United States
Site 16
Brandon, Florida, United States
Site 15
Clearwater, Florida, United States
Site 20
Miami Lakes, Florida, United States
Site 11
North Miami Beach, Florida, United States
Site 12
Pinellas Park, Florida, United States
Site 10
Carmel, Indiana, United States
...and 11 more locations