This Phase 3 study (Study 306) 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
DOUBLE
Enrollment
151
Topical Foam
Topical Foam
Center for Dermatology Clinical Research
Fremont, California, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Minnesota Clinical Study Center
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 of a subject's disease, taking into account all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very 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)
A static assessment of the overall or "average" degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. "Treatment success" is defined as a score of 0 or 1 representing "cleared" or "almost cleared" at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe).
Time frame: Day 15
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Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
The Center for Skin Research
Houston, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States