Patient-Reported Outcome Of Facial Erythema (PROOF) (PROOF)

Patient-Reported Outcomes of Brimonidine Tartrate 0.5% Gel for Treatment of Severe Facial Erythema of Rosacea

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.

Study Overview

• Status: Completed
• Conditions: Erythema; Rosacea
• Intervention / Treatment: Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.; Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Klinik für Dermatologie, Venerologie und Allergologie
  • Düsseldorf, Germany
    • Universitätsklinikum Düsseldorf
  • Frankfurt am Main, Germany
    • Klinikum der Johann Wolfgang Goethe-Universität
  • Münster, Germany
    • Universitätsklinikum Münster, Klinik fur Hautkrankheiten
  • Tübingen, Germany
    • Universitäts-Hautklinik Eberhard Karls Universität Tübingen
  • Wuppertal, Germany
    • CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)
  • Wuppertal, Germany
    • Zentrum für Dermatologie, Allergologie und Dermatochirurgie
• Sweden
  • Lund, Sweden
    • Capio Citykliniken
  • Stockholm, Sweden
    • Läkarhuset Odenplan
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • NHS Tayside
  • Leicester, United Kingdom
    • University Hospitals of Leicester
  • London, United Kingdom
    • Royal Free Hospital
  • London, United Kingdom
    • Whipps Cross University Hospital
  • Yorkshire, United Kingdom
    • Harrogate District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brimonidine tartrate 0.5% gel; Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.	Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.
PLACEBO_COMPARATOR: Vehicle; Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.	Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 8
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.	Day 8
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.	Day 8
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.	Baseline, Day 8
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.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 8
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.	Day 8
Change From Baseline in Facial Inflammatory Lesion Counts at Day 8	Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.	Day 8
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.	From start of study drug administration up to Day 8

Collaborators and Investigators

• Sponsor: Galderma R&D

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): November 14, 2013
• Study Completion (ACTUAL): November 14, 2013

Study Registration Dates

• First Submitted: June 20, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (ESTIMATE): June 24, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Erythema; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: RD.03.SPR.29107; 2012-005686-12 (EUDRACT_NUMBER)