Phase 4
Completed N=235
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Source: ClinicalTrials.gov NCT01426269 ↗Enrolled (actual)
235
Serious AEs
2.2%
Results posted
Aug 2014
Primary outcomePrimary: Period 2: Number of Subjects Who Relapsed — 4; 10; 8; 14 participants
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%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Period 2: Number of Subjects Who Relapsed |
4; 10; 8; 14; 9; 16 | — |
| SECONDARY Period 2: Investigator's Global Assessment Success |
44; 38; 36; 33; 33; 37 | — |
| SECONDARY Period 2: Clinician's Erythema Assessment |
5.0; 5.6; 4.9; 5.8; 4.7; 5.3 | — |
| SECONDARY Period 2: Inflammatory Lesion Count |
2.8; 5.8; 3.1; 4.3; 3.0; 1.9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01426269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.