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

NCT03297502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 582

Last updated 2017-09-29

No results posted yet for this study

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

Interventions

DRUG

pimecrolimus cream 1%

DRUG

Elidel (pimecrolimus) cream 1%

DRUG

placebo

Sponsors & Collaborators

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Davis, MD, RPh · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297502 on ClinicalTrials.gov