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Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® Capsules Compared to Placebo After an Initial 12 Week Treatment Regimen With Oracea® and MetroGel® 1% in Adults With Rosacea
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%.
Details
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 235 |
| Start date | 2011-09 |
| Completion | 2013-06 |
Conditions
- Rosacea
Interventions
- Doxycycline
- Metronidazole
- Placebo
Primary outcomes
- Period 2: Number of Subjects Who Relapsed — Period 2 (40 weeks)
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.
Countries
United States