Patient-Reported Outcome Of Facial Erythema (PROOF)

• Status: Completed
• Trial end date: 2013-11-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.

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

Details

• Lead Sponsor: Galderma; Galderma R&D
• Treatments: Brimonidine Tartrate

Criteria

Inclusion Criteria:

• Male or female subjects age of 18 years or older

• A clinical diagnosis of facial rosacea

• A Patient Self-Assessment score of 4 (severe) at Baseline prior to the study drug application

• A Clinician's Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application

Exclusion Criteria:

• More than 5 facial inflammatory lesions (papules or pustules) of rosacea

• Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator

• Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator's Brochure)

• Female who is pregnant or lactating