Patient-Reported Outcome Of Facial Erythema (PROOF)

Study Overview
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Brief Summary
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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.

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

Conditions
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Rosacea, Erythema

Intervention / Treatment
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* Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.
* Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brimonidine tartrate 0.5% gel<br>Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days. | Drug: Brimonidine tartrate was applied cutaneously once daily for 8 days.<br> <br> |
| Placebo Comparator: Vehicle<br>Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days. | Drug: Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.<br> <br> |

What is the study measuring?
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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 |