NCT01426269

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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%.

Detailed description

Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	Doxycycline	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
DRUG	Metronidazole	During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
DRUG	Placebo	During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-08-31
• Last updated: 2022-08-01
• Results posted: 2014-08-04

Locations

11 sites across 1 country: United States