Status:
COMPLETED
Patient-Reported Outcome Of Facial Erythema (PROOF)
Lead Sponsor:
Galderma R&D
Conditions:
Rosacea
Erythema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2013
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01885000
Start Date
July 1 2013
End Date
November 14 2013
Last Update
August 25 2021
Active Locations (14)
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1
Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany
2
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
3
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt am Main, Germany
4
Universitätsklinikum Münster, Klinik für Hautkrankheiten
Münster, Germany