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NCT01426269 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
A Phase 4 study, sponsored by Galderma R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 235
- Enrollment target
NCT01426269: Completed Phase 4 study, sponsored by Galderma R&D.
NCT01426269 is a Phase 4 study that has completed, run by Galderma R&D. The registered enrollment target is 235 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01426269, a Phase 4 study, has completed, sponsored by Galderma R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 235 participants
- Enrollment target
Study Summary
The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.
Primary Outcome
Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria: * A return to the baseline lesion count * A return to the baseline IGA score * The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.
Interventions
- DRUG Placebo
- DRUG Metronidazole
- DRUG Doxycycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 235 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
What the finished NCT01426269 record still lists
NCT01426269 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01426269 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01426269 about?
NCT01426269 is a clinical study titled "Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo". The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.
What is the current status of trial NCT01426269?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 235 participants. The study started on 2011-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01426269?
The interventions under investigation include: Placebo (DRUG), Metronidazole (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT01426269?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01426269's enrollment target sits among peer trials
235 369th of 2000 higher than 1,632 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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