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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: Completed Phase 3 study, sponsored by Actavis.
NCT02791308 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 587 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15
Interventions
- DRUG Vehicle cream
- DRUG Pimecrolimus Cream, 1%
- DRUG Pimecrolimus Cream 1% (Valeant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 587 participants |
| Start Date | 2015-02 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02791308 record still lists
NCT02791308 is an interventional study that assigns participants to a tested intervention. The registered 587 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Vehicle cream is the first listed.
NCT02791308 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02791308's enrollment target sits among peer trials
587 645th of 2000 higher than 1,354 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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