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NCT02791308 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
587
Enrollment target

NCT02791308 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 587 participants.

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The verdict

NCT02791308, a Phase 3 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
587 participants
Enrollment target

Study 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.

Interventions

  • DRUG Vehicle cream
  • DRUG Pimecrolimus Cream, 1%
  • DRUG Pimecrolimus Cream 1% (Valeant)

Trial Details

FieldValue
Enrollment Target 587 participants
Start Date 2015-02
Est. Completion 2016-07
Phase Phase 3

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT02791308

The ClinicalTrials.gov registry entry for NCT02791308 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 587 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Vehicle cream is the first listed.

NCT02791308 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02791308 about?

NCT02791308 is a clinical study titled "Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis". 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 ...

What is the current status of trial NCT02791308?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 587 participants. The study started on 2015-02. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02791308?

The interventions under investigation include: Vehicle cream (DRUG), Pimecrolimus Cream, 1% (DRUG), Pimecrolimus Cream 1% (Valeant) (DRUG).

Who is sponsoring clinical trial NCT02791308?

This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.