Back to resultsPatient-Reported Outcome Of Facial Erythema (PROOF) (PROOF)
Primary Purpose
Rosacea, Erythema
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brimonidine tartrate was applied cutaneously once daily for 8 days.
Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
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
Sites / Locations
- Klinik für Dermatologie, Venerologie und Allergologie
- Universitätsklinikum Düsseldorf
- Klinikum der Johann Wolfgang Goethe-Universität
- Universitätsklinikum Münster, Klinik für Hautkrankheiten
- Universitäts-Hautklinik Eberhard Karls Universität Tübingen
- CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
- Zentrum für Dermatologie, Allergologie und Dermatochirurgie
- Capio Citykliniken
- Läkarhuset Odenplan
- NHS Tayside
- University Hospitals of Leicester
- Royal Free Hospital
- Whipps Cross University Hospital
- Harrogate District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Brimonidine tartrate 0.5% gel
Vehicle
Arm Description
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
Percentage of Participants With Facial Redness Questionnaire at Day 8
Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life.
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on participant's life, [Grade 2-5]: Small effect at all on participant's life, [Grade 6-10]: Moderate effect at all on participant's life, [Grade 11-20]: Very large effect at all on participant's life, [Grade 21-30]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater.
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
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Secondary Outcome Measures
Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1- Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. Percentage of participants with at least two grade improvement in the CEA was reported.
Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
Percentage of participants with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness.
Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.
Number of Participants Reported Adverse Events
All clinical medical events, whether observed by the investigator or reported by the participant and whether or not thought to be product- or study procedure-related were considered as adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885000
Brief Title
Patient-Reported Outcome Of Facial Erythema (PROOF)
Acronym
PROOF
Official Title
Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
November 14, 2013 (Actual)
Study Completion Date
November 14, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Erythema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brimonidine tartrate 0.5% gel
Arm Type
Experimental
Arm Description
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate was applied cutaneously once daily for 8 days.
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
Description
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
Time Frame
Day 8
Title
Percentage of Participants With Facial Redness Questionnaire at Day 8
Description
Percentage of participants for each category of facial redness questionnaire on Day 8 was reported. Facial redness questionnaire included 12 questions/categories 1. Satisfied with appearance, 2. Appearance acceptable, 3. Appearance concerned, 4. Embarrassed with facial redness, 5. Self-conscious, 6. Frequency control last 24 hours, 7. Frustrated, 8. Cover up or camouflage, 9. Pay attention to the known triggers, 10. Avoid the known triggers, 11. Interfering with social life, 12. Interfering with work life.
Time Frame
Day 8
Title
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
Description
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Time Frame
Day 8
Title
Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
Description
DLQI was a compact health-related quality of life index that has 10 questions and depends on the participants self-declaration about experiences during the previous week. DLQI results range between grades 0 and 30. [Grade 0-1]: No effect at all on participant's life, [Grade 2-5]: Small effect at all on participant's life, [Grade 6-10]: Moderate effect at all on participant's life, [Grade 11-20]: Very large effect at all on participant's life, [Grade 21-30]: Extremely large effect at all on participant's life. As the DLQI scores increase, the impact of the studied disease on life becomes greater.
Time Frame
Baseline, Day 8
Title
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
Description
EQ-5D-3L is a 3-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprises 3 levels with corresponding numeric scores, where 1 indicates no problems, and 3 indicates extreme problems. Participant selects answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-3L total score indicates improvement.
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
Description
Evaluation of erythema by using CEA was assessed by 0 to 4 grades, where 0-Clear skin with no signs of erythema, 1- Almost clear; slight redness, 2-Mild erythema; definite redness, 3-Moderate erythema; marked redness, 4-Severe erythema; fiery redness. Percentage of participants with at least two grade improvement in the CEA was reported.
Time Frame
Day 8
Title
Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
Description
Percentage of participants with at least two grade improvement in the PSA was reported. Evaluation of erythema severity by using the PSA grades (0-4): 0- No redness, 1- very mild redness, 2-mild redness, 3-moderate redness, 4-severe redness.
Time Frame
Day 8
Title
Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
Description
Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.
Time Frame
Day 8
Title
Number of Participants Reported Adverse Events
Description
All clinical medical events, whether observed by the investigator or reported by the participant and whether or not thought to be product- or study procedure-related were considered as adverse events.
Time Frame
From start of study drug administration up to Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Klinik für Dermatologie, Venerologie und Allergologie
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität
City
Frankfurt am Main
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Hautkrankheiten
City
Münster
Country
Germany
Facility Name
Universitäts-Hautklinik Eberhard Karls Universität Tübingen
City
Tübingen
Country
Germany
Facility Name
CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
City
Wuppertal
Country
Germany
Facility Name
Zentrum für Dermatologie, Allergologie und Dermatochirurgie
City
Wuppertal
Country
Germany
Facility Name
Capio Citykliniken
City
Lund
Country
Sweden
Facility Name
Läkarhuset Odenplan
City
Stockholm
Country
Sweden
Facility Name
NHS Tayside
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Whipps Cross University Hospital
City
London
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Yorkshire
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26416154
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.
Results Reference
derived
Learn more about this trial
Patient-Reported Outcome Of Facial Erythema (PROOF)
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