Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo After 12 Weeks of Oracea® and MetroGel® 1%
This trial is active, not recruiting.
|Treatments||oral doxycycline and topical metronidazole, oral doxycycline, placebo|
|Sponsor||Galderma Laboratories, L.P.|
|Start date||September 2011|
|End date||June 2013|
|Trial size||200 participants|
|Trial identifier||NCT01426269, US10183|
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%.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Santa Monica, CA||ATS Clinical Research||no longer recruiting|
|Coral Gables, FL||Dadeland Dermatology||no longer recruiting|
|Corbin, KY||Melissa L. F. Knuckles M.D., P.S.C.||no longer recruiting|
|Louisville, KY||Dermatology Specialists Research||no longer recruiting|
|Richmond, KY||Melissa L. F. Knuckles M.D., P.S.C.||no longer recruiting|
|Hunt Valley, MD||The Maryland Laser, Skin, and Vein Institute, LLC||no longer recruiting|
|Warren, MI||Grekin Skin Institute||no longer recruiting|
|Brooklyn, NY||Hilary Baldwin||no longer recruiting|
|Rochester, NY||The Center for Dermatology at Linden Oaks||no longer recruiting|
|Warren, OH||Brodell Medical, Inc.||no longer recruiting|
|Portland, OR||Center for Dermatology and Laser Surgery||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Percentage of subjects who relapse during phase 2 of the study
time frame: Phase 2 (week 12 - week 52)
Change from baseline in inflammatory lesion counts
time frame: Baseline - week 52
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Baseline - week 52
Male or female participants from 18 years up to 80 years old.
- 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.
- 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.
|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|
|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.|
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