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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive placebo during phase 2 (week 12 - week 52) | Drug: Placebo<br>* During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning<br>|
| Other: Doxycycline and Metronidazole<br>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) | Drug: Doxycycline<br>* During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning<br>* Other names: Oracea® Capsules 40 mg;Drug: Metronidazole<br>* During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area<br>* Other names: Metrogel 1%;|
| Active Comparator: Doxycycline<br>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) | Drug: Doxycycline<br>* During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning<br>* Other names: Oracea® Capsules 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period 2: Number of Subjects Who Relapsed | 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. | Period 2 (40 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period 2: Investigator's Global Assessment Success | 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 (40 weeks) | 
| Period 2: Clinician's Erythema Assessment | 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. | Period 2 (40 Weeks) | 
| Period 2: Inflammatory Lesion Count | The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit. | Period 2 (40 Weeks) |