CompletedPhase 3

Patient-Reported Outcome Of Facial Erythema (PROOF)

Germany, Sweden, United Kingdom92 participantsStarted 2013-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment

Timeframe: Day 8

Percentage of Participants With Facial Redness Questionnaire at Day 8

Timeframe: Day 8

EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8

Timeframe: Day 8

Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8

Timeframe: 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

Timeframe: Day 8

Trial details

NCT IDNCT01885000

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11-14

Results submitted2016-11-17

View on ClinicalTrials.gov More Rosacea trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment

Timeframe: Day 8

Percentage of Participants With Facial Redness Questionnaire at Day 8

Timeframe: Day 8

EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8

Timeframe: Day 8

Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8

Timeframe: 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

Timeframe: Day 8