Clinical trial NCT01885000: Patient-Reported Outcome Of Facial Erythema (PROOF)
Official title: Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rosacea
Erythema
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
timeFrame: Day 8
measure: Percentage of Participants With Facial Redness Questionnaire at Day 8
timeFrame: Day 8
measure: EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
timeFrame: Day 8
measure: Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
timeFrame: Baseline, Day 8
measure: Euro Quality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire (Along With a Visual Analogue Score for the Overall Health State) at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
timeFrame: Day 8
measure: Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
timeFrame: Day 8
measure: Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
timeFrame: Day 8
measure: Number of Participants Reported Adverse Events
timeFrame: From start of study drug administration up to Day 8
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Dermatologie, Venerologie und Allergologie
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Hautkrankheiten
city: Tübingen
country: Germany
facility: Universitäts-Hautklinik Eberhard Karls Universität Tübingen
city: Wuppertal
country: Germany
facility: CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
city: Wuppertal
country: Germany
facility: Zentrum für Dermatologie, Allergologie und Dermatochirurgie
city: Lund
country: Sweden
facility: Capio Citykliniken
city: Stockholm
country: Sweden
facility: Läkarhuset Odenplan
city: Dundee
country: United Kingdom
facility: NHS Tayside
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: Yorkshire
country: United Kingdom
facility: Harrogate District Hospital
Study officials:
References:
citation: 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.