| Primary | 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.
| | Posted | | Number | | participants | | Period 2 (40 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Oral Doxycycline | Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning | | OG001 | Placebo | Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Placebo: During period 2, placebo, oral, one capsule daily in the morning |
| | | Title | Denominators | Categories |
|---|
| Week 4 | | | | Week 8 | | |
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| Secondary | 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). | | Posted | | Number | | participants | | Period 2 (40 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Oral Doxycycline | Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning | | OG001 | Placebo | Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Placebo: During period 2, placebo, oral, one capsule daily in the morning |
| |
| Secondary | 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. | | Posted | | Mean | Standard Deviation | units on a scale | | Period 2 (40 Weeks) | | | | ID | Title | Description |
|---|
| OG000 | Oral Doxycycline | Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning | | OG001 | Placebo | Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Placebo: During period 2, placebo, oral, one capsule daily in the morning |
| |
| Secondary | Period 2: Inflammatory Lesion Count | The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit. | | Posted | | Mean | Standard Deviation | lesions | | Period 2 (40 Weeks) | | | | ID | Title | Description |
|---|
| OG000 | Oral Doxycycline | Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning | | OG001 | Placebo | Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole. Placebo: During period 2, placebo, oral, one capsule daily in the morning |
| |
| Other Pre-specified | Period 1: Tolerability (Scaling) | Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. | | Posted | | Number | | participants | | Period 1 (12 Weeks) | | | | ID | Title | Description |
|---|
| OG000 | Baseline | 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) | | OG001 | Week 4 | 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) | | OG002 | Week 8 | 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) | | OG003 | Week 12 | 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) |
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| Other Pre-specified | Period 1: Tolerability (Stinging/Burning) | Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. | | Posted | | Number | | participants | | Period 1 (12 Weeks) | | | | ID | Title | Description |
|---|
| OG000 | Baseline | 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) | | OG001 | Week 4 | 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) | | OG002 | Week 8 | 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) | | OG003 | Week 12 | 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) |
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| Other Pre-specified | Period 1: Tolerability (Dryness) | Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole. | | Posted | | Number | | participants | | Period 1 (12 Weeks) | | | | ID | Title | Description |
|---|
| OG000 | Baseline | 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) | | OG001 | Week 4 | 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) | | OG002 | Week 8 | 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) | | OG003 | Week 12 | 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) |
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