A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
494
Once daily for 4 weeks (28 days)
Once daily for 4 weeks (28 days)
Once daily for 4 weeks (28 days)
The proportion of subjects in each treatment group with treatment success
Treatment success defined as none or minimal disease , a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity
Time frame: Day 29
The proportion of subjects in each treatment group with clinical success
Clinical success defined as clear or almost clear, a score of 0 or 1, at the target lesion site on the PASI scale. Each psoriatic sign of scaling, erythema, and plaque elevation should have a score of 0 or 1
Time frame: Day 29
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Investigational Site 20
Encinitas, California, United States
Investigational Site 18
Fountain Valley, California, United States
Investigational Site 19
San Diego, California, United States
Investigational Site 15
San Diego, California, United States
Investigational Site 23
San Diego, California, United States
Investigational Site 17
Santa Ana, California, United States
Investigational Site 22
Santa Monica, California, United States
Investigational Site 29
Clearwater, Florida, United States
Investigational Site 27
Coral Gables, Florida, United States
Investigational Site 1
Miami, Florida, United States
...and 20 more locations