Phase 3
Completed N=683
Phase 3 Papulopustular Rosacea Study
Papulopustular Rosacea (PPR)
Source: ClinicalTrials.gov NCT01493687 ↗
Enrolled (actual)
683
Serious AEs
1.6%
Results posted
Jan 2015
Primary outcomePrimary: Success Rate — 38.4; 11.6 Percentage of participants — p=<0.001
Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate |
38.4; 11.6 | <0.001 sig |
| PRIMARY Absolute Change in Inflammatory Lesion Count |
-20.5; -12.0 | <0.001 sig |
| SECONDARY Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) |
-64.9; -41.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
Data sourced from ClinicalTrials.gov (NCT01493687). 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.