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

Rosacea Clinical Trial

Official title:
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

Clinical Trial 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%.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01426269
Study type Interventional
Source Galderma R&D
Contact
Status Completed
Phase Phase 4
Start date September 2011
Completion date June 2013
View Details
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