NCT03297502

Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis

Multicenter Study of the Safety and Bioequivalence of Par's Pimecrolimus Cream, 1% and RLD Elidel® (Pimecrolimus Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: Par Pharmaceutical, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

A phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter study to evaluate the safety and bioequivalence of Par Pharmaceutical Inc.'s Pimecrolimus Cream, 1% and Reference Listed Elidel® (Pimecrolimus Cream, 1%). The study compares both active treatments to a placebo control in the treatment of mild to moderate atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	pimecrolimus cream 1%
DRUG	Elidel (pimecrolimus) cream 1%
DRUG	placebo

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2017-09-29
• Last updated: 2017-09-29