Phase 3
N=70
Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea
Erythema · Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT01659853 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Composite Success — 14.3; 5.7 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CD07805/47 gel 0.5%/CD07805/47 Vehicle (Drug); azelaic acid gel 15% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Success |
14.3; 5.7 | — |
| SECONDARY Onset of Action |
31.4; 29.4 | — |
Summary
The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.
Eligibility Criteria
Inclusion Criteria
- Subject is male or female aged 18 years or older.
- Subject has a clinical diagnosis of facial rosacea.
- Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
- Subject has a self assessment score of moderate to severe redness prior to enrollment.
- Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.
Exclusion Criteria
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
- Subjects with conditions causing facial erythema which would confound the assessment of treatment.
- Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
- Subjects with known allergies or sensitivities to one of the components of the investigational products.
Data sourced from ClinicalTrials.gov (NCT01659853). 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.