Patient-Reported Outcome Of Facial Erythema (PROOF)

Phase 3

Completed

• Conditions: Rosacea; Erythema
• Interventions: Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.; Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.

• Registration Number: NCT01885000
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-20
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Study Start: 2013-07-01
• Primary Completion: 2013-11-14
• Study Completion: 2013-11-14
• Results First Submitted: 2016-11-17
• Results First Submitted QC: 2016-11-17
• Results First Posted: 2017-01-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.	Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
Brimonidine tartrate 0.5% gel	Brimonidine tartrate was applied cutaneously once daily for 8 days.	Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.

Primary Outcome Measures

Name	Time	Method
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8	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.
Percentage of Participants With Facial Redness Questionnaire at Day 8	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.
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment	Day 8	Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8	Baseline, 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	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

Name	Time	Method
Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)	Day 8	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	Day 8	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	Day 8	Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.
Number of Participants Reported Adverse Events	From start of study drug administration up to Day 8	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.

Trial Locations

Locations (14)

Klinikum der Johann Wolfgang Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Münster, Klinik für Hautkrankheiten; 🇩🇪 Münster, Germany

Universitäts-Hautklinik Eberhard Karls Universität Tübingen; 🇩🇪 Tübingen, Germany

Zentrum für Dermatologie, Allergologie und Dermatochirurgie; 🇩🇪 Wuppertal, Germany

Klinik für Dermatologie, Venerologie und Allergologie; 🇩🇪 Berlin, Germany

Capio Citykliniken; 🇸🇪 Lund, Sweden

CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH); 🇩🇪 Wuppertal, Germany

Läkarhuset Odenplan; 🇸🇪 Stockholm, Sweden

NHS Tayside; 🇬🇧 Dundee, United Kingdom

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