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NCT03107611 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
A Phase 3 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 3
- Development phase
- 654
- Enrollment target
NCT03107611 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 654 participants.
The verdict
NCT03107611, a Phase 3 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 654 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo Cream
- DRUG Pimecrolimus Cream, 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2016-02-29 |
| Est. Completion | 2017-05-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03107611
The ClinicalTrials.gov registry entry for NCT03107611 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 654 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Cream is the first listed.
NCT03107611 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03107611 about?
NCT03107611 is a clinical study titled "Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis". 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.
What is the current status of trial NCT03107611?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 654 participants. The study started on 2016-02-29. Estimated completion is 2017-05-15.
What interventions are being tested in trial NCT03107611?
The interventions under investigation include: Placebo Cream (DRUG), Pimecrolimus Cream, 1% (DRUG).
Who is sponsoring clinical trial NCT03107611?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
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