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Calcineurin Inhibitor

Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

Phase 3
Waitlist Available
Research Sponsored by Actavis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial

Summary

The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Subjects With Treatment Success at Visit 4/Day 15

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Pimecrolimus Cream, 1%Experimental Treatment1 Intervention
Pimecrolimus Cream, 1% (Actavis)
Group II: Elidel Cream, 1%Active Control1 Intervention
Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Group III: Vehicle CreamPlacebo Group1 Intervention
Cream vehicle of the test product (Actavis)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimecrolimus
FDA approved

Find a Location

Who is running the clinical trial?

Actavis Inc.Lead Sponsor
98 Previous Clinical Trials
24,660 Total Patients Enrolled
Beth LandisStudy DirectorSenior Clinical Project Manager
~54 spots leftby Dec 2025
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