Patient-Reported Outcome Of Facial Erythema (PROOF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01885000
First received: June 20, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Rosacea
Erythema
Drug: once-daily brimonidine tartrate 0.5% gel
Drug: once-daily brimonidine tartrate vehicle gel
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • satisfaction with the overall study treatment [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in satisfaction with appearance of facial skin [ Time Frame: Day 8 ]
  • Change from baseline in mean CEA [ Time Frame: 3 hour after drug application ]
  • Percentage of subject reporting a treatment-related adverse event [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: July 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885000

Locations
Germany
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
Zentrum für Dermatologie, Allergologie und Dermatochirurgie
Wuppertal, Germany
CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
Wuppertal, Germany
Sweden
Capio Citykliniken
Lund, Sweden
Läkarhuset Odenplan
Stockholm, Sweden
United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
University Hospitals of Leicester
Leicester, United Kingdom
Whipps Cross University Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Harrogate District Hospital
Yorkshire, United Kingdom
Sponsors and Collaborators
Galderma
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01885000     History of Changes
Other Study ID Numbers: RD.03.SPR.29107
Study First Received: June 20, 2013
Last Updated: March 24, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Erythema
Skin Diseases
Brimonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014