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

Completed · Phase 4 · Has a placebo group

Conditions studied: Rosacea

In brief

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%.

Key facts

Study ID

NCT01426269

Run by

Galderma R&D

People needed

235

Starts

2011-09-01

Expected to finish

2013-06-01

Last updated by the study team

2022-08-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ATS Clinical Research — Santa Monica, California, United States
• Dadeland Dermatology — Coral Gables, Florida, United States
• Melissa L. F. Knuckles M.D., P.S.C. — Corbin, Kentucky, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• Melissa L. F. Knuckles M.D., P.S.C. — Richmond, Kentucky, United States
• The Maryland Laser, Skin, and Vein Institute, LLC — Hunt Valley, Maryland, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Hilary Baldwin — Brooklyn, New York, United States
• The Center for Dermatology at Linden Oaks — Rochester, New York, United States
• Brodell Medical, Inc. — Warren, Ohio, United States
• Center for Dermatology and Laser Surgery — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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