Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
92 participants
INTERVENTIONAL
2013-07-01
2013-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brimonidine tartrate 0.5% gel
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
Brimonidine tartrate was applied cutaneously once daily for 8 days.
Vehicle
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Interventions
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Brimonidine tartrate was applied cutaneously once daily for 8 days.
Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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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
NHS Tayside
Dundee, , 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
Countries
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References
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Layton AM, Schaller M, Homey B, Hofmann MA, Bewley AP, Lehmann P, Nohlgard C, Sarwer DB, Kerrouche N, Ma YM. Brimonidine gel 0.33% rapidly improves patient-reported outcomes by controlling facial erythema of rosacea: a randomized, double-blind, vehicle-controlled study. J Eur Acad Dermatol Venereol. 2015 Dec;29(12):2405-10. doi: 10.1111/jdv.13305. Epub 2015 Sep 28.
Other Identifiers
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2012-005686-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RD.03.SPR.29107
Identifier Type: -
Identifier Source: org_study_id
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