Phase 3Completed
To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)
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)
- Sponsor
- Glenmark Pharmaceuticals Ltd. India (Industry)
- Enrolment
- 1,110 enrolled
- Conditions
- Atopic Dermatitis
- Interventions
- Tacrolimus Ointment 0.1%; Protopic® ointment, 0.1%; Placebo of Tacrolimus Ointment
- Ages
- adults, older adults
- Registry
- NCT02601703
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
History
Last registry update
Primary completion
Registered
Started