At a glance
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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
In Brief
A Phase 4 clinical trial evaluating Doxycycline, Metronidazole, and 1 other intervention for Rosacea. Completed, enrolled 235 participants across 11 sites.
Detailed 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%.
Study Details
Timeline
Interventions
During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads), oral, one capsule daily in the morning
During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning