This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,110
apply thin layer of ointment to affected area
apply thin layer of ointment to affected area
apply thin layer of ointment to affected area
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
Time frame: Day 15
The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).
Time frame: Day 15
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Glenmark Investigational Site 49
Tempe, Arizona, United States
Glenmark Investigational Site 31
Anaheim, California, United States
Glenmark Investigational Site 23
Bell Gardens, California, United States
Glenmark Investigational Site 30
Cerritos, California, United States
Glenmark Investigational Site 15
Chula Vista, California, United States
Glenmark Investigational Site 14
La Mesa, California, United States
Glenmark Investigational Site 1
Long Beach, California, United States
Glenmark Investigational Site 17
Oceanside, California, United States
Glenmark Investigational Site 25
Pasadena, California, United States
Glenmark Investigational Site 20
San Ramon, California, United States
...and 50 more locations