Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma Laboratories, L.P.
• Treatments: Azelaic acid; Brimonidine Tartrate

Criteria

Inclusion Criteria:

1. Subject is male or female aged 18 years or older.

2. Subject has a clinical diagnosis of facial rosacea.

3. Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.

4. Subject has a self assessment score of moderate to severe redness prior to enrollment.

5. Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

1. Female subjects who are pregnant, nursing or planning a pregnancy during the study.

2. 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.

3. Subjects with conditions causing facial erythema which would confound the assessment of treatment.

4. Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.

5. Subjects with known allergies or sensitivities to one of the components of the investigational products.