Patient-Reported Outcome Of Facial Erythema (PROOF)

NCT01885000 | Completed Phase 3 Results

• 2 other identifiers: RD.03.SPR.291072012-005686-12
• Study Type: interventional
• Target: 92
• Locations: 3 countries
• Sites: 14

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.

Conditions

Rosacea; Erythema

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)

  Day 8

• Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment

  Day 8

• Change From Baseline in Facial Inflammatory Lesion Counts at Day 8

  Day 8

• Number of Participants Reported Adverse Events

  From start of study drug administration up to Day 8

Study Arms (2)

Brimonidine tartrate 0.5% gel

EXPERIMENTAL

Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.

Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.

Vehicle

PLACEBO COMPARATOR

Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.

Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.

Interventions

Brimonidine tartrate was applied cutaneously once daily for 8 days. DRUG

Brimonidine tartrate 0.5% gel

Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days. DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (14)

Klinik für Dermatologie, Venerologie und Allergologie

Berlin, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt am Main, Germany

Location

Universitätsklinikum Münster, Klinik für Hautkrankheiten

Münster, Germany

Location

Universitäts-Hautklinik Eberhard Karls Universität Tübingen

Tübingen, Germany

Location

CentroDerm Gesellschaft für dermatolgische Forschung mbH (GmbH)

Wuppertal, Germany

Location

Zentrum für Dermatologie, Allergologie und Dermatochirurgie

Wuppertal, Germany

Location

Capio Citykliniken

Lund, Sweden

Location

Läkarhuset Odenplan

Stockholm, Sweden

Location

NHS Tayside

Dundee, DD1 9SY, United Kingdom

Location

University Hospitals of Leicester

Leicester, United Kingdom

Location

Royal Free Hospital

London, United Kingdom

Location

Whipps Cross University Hospital

London, United Kingdom

Location

Harrogate District Hospital

Yorkshire, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26416154 DERIVED

MeSH Terms

Conditions

Rosacea; Erythema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 24, 2013
• Study Start: July 1, 2013
• Primary Completion: November 14, 2013
• Study Completion: November 14, 2013
• Last Updated: August 25, 2021
• Results First Posted: January 13, 2017

Record last verified: 2021-08

Locations

DE (7); SE (2); GB (5)