This Phase 3 study has been designed to determine and compare the efficacy and safety of 000-0551 Lotion and Vehicle Lotion applied twice daily for two weeks in subjects with plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
222
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, United States
MOORE Clinical Research, Inc.
Brandon, Florida, United States
Florida Academic Dermatology Center
Miami, Florida, United States
The 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
The 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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Park Avenue Dermatology, PA
Orange Park, Florida, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
The Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
...and 1 more locations