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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: Completed Phase 3 study, sponsored by Mylan.
NCT03107611 is a Phase 3 study that has completed, run by Mylan. The registered enrollment target is 654 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright
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 |
What the finished NCT03107611 record still lists
NCT03107611 is an interventional study that assigns participants to a tested intervention. The registered 654 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 (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Cream is the first listed.
NCT03107611 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03107611's enrollment target sits among peer trials
654 567th of 2000 higher than 1,430 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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