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Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

NCT03107611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 654

Last updated 2022-03-07

Study results available
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Summary

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.

To establish superiority of each active treatment over the placebo.

Conditions

Interventions

DRUG

Pimecrolimus Cream, 1%

DRUG

Placebo Cream

DRUG

Pimecrolimus Cream, 1%

Sponsors & Collaborators

  • DPT Laboratories, Ltd.

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-15
Completion
2017-05-15
FDA Drug
Yes

Countries

  • United States
  • Dominican Republic
  • Honduras

Study Locations

More Related Trials

Entities

Diseases

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 NCT03107611 on ClinicalTrials.gov