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

Phase 4

Completed

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 MetroGel® 1%.

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 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subjects will receive placebo during phase 2 (week 12 - week 52)
Doxycycline	Doxycycline	Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)
Doxycycline and Metronidazole	Metronidazole	Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
Doxycycline and Metronidazole	Doxycycline	Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)

Primary Outcome Measures

Name	Time	Method
Period 2: Number of Subjects Who Relapsed	Period 2 (40 weeks)	Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria: * A return to the baseline lesion count * A return to the baseline IGA score * The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm.

Secondary Outcome Measures

Name	Time	Method
Period 2: Investigator's Global Assessment Success	Period 2 (40 weeks)	The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).
Period 2: Inflammatory Lesion Count	Period 2 (40 Weeks)	The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.
Period 2: Clinician's Erythema Assessment	Period 2 (40 Weeks)	The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.

Locations (10): ATS Clinical Research
🇺🇸
Santa Monica, California, United States
Melissa L. F. Knuckles M.D., P.S.C.
🇺🇸
Richmond, Kentucky, United States
Dadeland Dermatology
🇺🇸
Coral Gables, Florida, United States
The Maryland Laser, Skin, and Vein Institute, LLC
🇺🇸
Hunt Valley, Maryland, 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
Grekin Skin Institute
🇺🇸
Warren, Michigan, United States
Dermatology Specialists Research
🇺🇸
Louisville, Kentucky, United States
Center for Dermatology and Laser Surgery
🇺🇸
Portland, Oregon, United States