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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 is a Phase 3 study that has completed, run by Fougera Pharmaceuticals. The registered enrollment target is 793 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01053247
The ClinicalTrials.gov registry entry for NCT01053247 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 793 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fougera Pharmaceuticals, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 0416 is the first listed.
NCT01053247 reports 0 study locations.
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.
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