Patient-Reported Outcome Of Facial Erythema (PROOF)

Condition(s) targeted: Rosacea; Erythema

Intervention: once-daily brimonidine tartrate 0.5% gel (Drug); once-daily brimonidine tartrate vehicle gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

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.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: satisfaction with the overall study treatment

Secondary outcome:

Change from baseline in satisfaction with appearance of facial skin

Change from baseline in mean CEA

Percentage of subject reporting a treatment-related adverse event

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Klinik für Dermatologie, Venerologie und Allergologie, Berlin, Germany

Universitätsklinikum Düsseldorf, Düsseldorf, Germany

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany

Universitätsklinikum Münster, Klinik für Hautkrankheiten, Münster, Germany

Universitäts-Hautklinik Eberhard Karls Universität Tübingen, Tübingen, Germany

CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH), Wuppertal, Germany

Zentrum für Dermatologie, Allergologie und Dermatochirurgie, Wuppertal, Germany

Capio Citykliniken, Lund, Sweden

Läkarhuset Odenplan, Stockholm, Sweden

NHS Tayside, Dundee DD1 9SY, United Kingdom

University Hospitals of Leicester, Leicester, United Kingdom

Royal Free Hospital, London, United Kingdom

Whipps Cross University Hospital, London, United Kingdom

Harrogate District Hospital, Yorkshire, United Kingdom

Starting date: July 2013
Last updated: March 24, 2014