NCT02601703

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,110 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tacrolimus Ointment 0.1%	apply thin layer of ointment to affected area
DRUG	Protopic® ointment, 0.1%	apply thin layer of ointment to affected area
DRUG	Placebo of Tacrolimus Ointment	apply thin layer of ointment to affected area

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-11-10
• Last updated: 2019-07-31

Locations

60 sites across 1 country: United States