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NCT01053247 · ClinicalTrials.gov registry record · Phase 3
Study of 0416 Ointment in the Treatment of Atopic Dermatitis
A Phase 3 study, sponsored by Fougera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT01053247: Completed Phase 3 study, sponsored by Fougera Pharmaceuticals.
NCT01053247 is a Phase 3 study that has completed, run by Fougera Pharmaceuticals. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053247, a Phase 3 study, has completed, sponsored by Fougera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study Summary
The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a day, approximately 12 hours apart, for approximately 2 weeks.
Interventions
- DRUG 0416
- DRUG Vehicle of 0416 test product
- DRUG tacrolimus ointment 0.1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT01053247 record still lists
NCT01053247 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which 0416 is the first listed.
NCT01053247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01053247 about?
NCT01053247 is a clinical study titled "Study of 0416 Ointment in the Treatment of Atopic Dermatitis". The aim of this trial is to assess the efficacy of 0416 Ointment in the Treatment of Atopic Dermatitis. Treatment medication will be administered as follows: Apply a thin layer of ointment to affected skin areas twice daily and rub in gently and completely. Study medication will be applied twice a ...
What is the current status of trial NCT01053247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2008-01. Estimated completion is 2009-08.
What interventions are being tested in trial NCT01053247?
The interventions under investigation include: 0416 (DRUG), Vehicle of 0416 test product (DRUG), tacrolimus ointment 0.1% (DRUG).
Who is sponsoring clinical trial NCT01053247?
This trial is sponsored by Fougera Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01053247's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 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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