NCT02896101

Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Glenmark Pharmaceuticals Ltd. India · Industry
• Sex: All
• Age: 12 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 Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Pimecrolimus Cream, 1%
DRUG	Elidel® (pimecrolimus) Cream
DRUG	Placebo of Pimecrolimus Cream, 1%

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-09-12
• Last updated: 2019-07-31

Locations

27 sites across 1 country: United States