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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Doxycycline; Metronidazole

Criteria

Inclusion Criteria:

• Subject is male or female aged 18 to 80 years inclusive.

• Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of moderate or severe.

• For subjects using medications to treat a concurrent medical condition, type and dose must have been stable for at least 90 days prior to study entry.

Exclusion Criteria:

• Female subjects who are pregnant, nursing or planning a pregnancy during the study.

• Subject has any other active dermatological condition on the face that may interfere with the conduct of the study.

• Subject uses or has recently used any medication which may interfere with the absorption, distribution, or elimination of study medications, or may interfere with the assessments of efficacy or safety of the study medications.

• Subject has a known allergy to any of the components of the study products, and/or a known hypersensitivity to tetracyclines or metronidazole.