This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
643
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Time frame: Day 29
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
Time frame: Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site 24
Encinitas, California, United States
Investigational Site 3
Fremont, California, United States
Investigational Site 13
San Diego, California, United States
Investigational Site 20
San Diego, California, United States
Investigational Site 32
Santa Monica, California, United States
Investigational Site 14
Denver, Colorado, United States
Investigational Site 1
Miami, Florida, United States
Investigational Site 30
Miami, Florida, United States
Investigational Site 7
Miramar, Florida, United States
Investigational Site 22
Tampa, Florida, United States
...and 21 more locations