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Patient-Reported Outcome Of Facial Erythema (PROOF) (PROOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01885000
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : January 13, 2017
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Galderma R&D

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 receiving the active drug will be compared to the feedback of patients receiving the placebo.

Condition or disease Intervention/treatment Phase
Rosacea Erythema Drug: once-daily brimonidine tartrate 0.5% gel Drug: once-daily brimonidine tartrate vehicle gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Experimental: Brimonidine tartrate 0.5% gel
once-daily brimonidine tartrate 0.5% gel
Drug: once-daily brimonidine tartrate 0.5% gel
Placebo Comparator: Vehicle
once-daily brimonidine tartrate vehicle gel
Drug: once-daily brimonidine tartrate vehicle gel

Primary Outcome Measures :
  1. Satisfaction With the Overall Study Treatment [ Time Frame: Day 8 ]
    Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment

Secondary Outcome Measures :
  1. Facial Appearance Since Starting the Treatment [ Time Frame: Day 8 ]
    Percentage of subjects who answered A lot better/A little better to the question "what do you think about your facial appearance since starting the treatment?"

  2. Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA) [ Time Frame: Day 1, 3 hour after drug application ]
    Percentage of participants with at least one grade improvement in the CEA

  3. Percentage of Subject Reporting a Treatment-related Adverse Event [ Time Frame: From consent signature, up to Day 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01885000

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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
United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
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
Sponsors and Collaborators
Galderma R&D
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Galderma R&D Identifier: NCT01885000    
Other Study ID Numbers: RD.03.SPR.29107
First Posted: June 24, 2013    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: February 28, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Skin Diseases
Skin Manifestations
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs