Status:
COMPLETED
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Lead Sponsor:
Galderma R&D
Conditions:
Rosacea
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 ...
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 pha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT01426269
Start Date
September 1 2011
End Date
June 1 2013
Last Update
August 1 2022
Active Locations (11)
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1
ATS Clinical Research
Santa Monica, California, United States, 90404
2
Dadeland Dermatology
Coral Gables, Florida, United States, 33134
3
Melissa L. F. Knuckles M.D., P.S.C.
Corbin, Kentucky, United States, 40701
4
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202