drugset / Trial / NCT02896101

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

NCT02896101

Phase 3 Completed 755 enrolled Glenmark Pharmaceuticals Ltd. India
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2016-08
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pimecrolimus Small molecule 1 % Topical

Indications