Trial Outcomes & Findings for Patient-Reported Outcome Of Facial Erythema (PROOF) (NCT NCT01885000)
NCT ID: NCT01885000
Last Updated: 2021-08-25
Results Overview
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
COMPLETED
PHASE3
92 participants
Day 8
2021-08-25
Participant Flow
This study was conducted at fourteen centers in Germany, Sweden, United Kingdom from 01 July 2013 (first participant visit) to 14 November 2013 (last participant completed).
A total of 92 participants were randomized, of which 88 participants completed the study.
Participant milestones
| Measure |
Brimonidine Tartrate 0.5% Gel
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
44
|
|
Overall Study
COMPLETED
|
46
|
42
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Brimonidine Tartrate 0.5% Gel
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Patient-Reported Outcome Of Facial Erythema (PROOF)
Baseline characteristics by cohort
| Measure |
Brimonidine Tartrate 0.5% Gel
n=48 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=44 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
54.9 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Skin phototype
Type I
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Skin phototype
Type II
|
34 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Skin phototype
Type III
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here over all number of participants 'N' analyzed signifies number of participants evaluable for this outcome measure.
Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment were reported.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Percentage of Participants Who Are Very Satisfied/Satisfied/Somewhat Satisfied With the Overall Study Treatment
|
69.6 Percentage of participants
|
40.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here over all number of participants 'N' analyzed signifies number of participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
4. Slightly/ Somewhat/Moderately/Extremely
|
71.7 percentage of participants
|
90.4 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
6. Not at all
|
23.9 percentage of participants
|
31.7 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
6.Slightly/Somewhat/Moderately/Extremel y
|
76.1 percentage of participants
|
68.2 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
8. Slightly/Somewhat
|
23.9 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
9. Not at all/Rarely
|
47.8 percentage of participants
|
48.8 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
10.Not at all/Rarely
|
47.8 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
12.Not at all
|
26.7 percentage of participants
|
23.8 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
12.Slight/Somewhat/Moderate/Extreme/ Not Applicable/I'm not working
|
73.4 percentage of participants
|
76.2 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
3. Somewhat /Moderately /Extremely
|
71.7 percentage of participants
|
78.6 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
1. Very dissatisfied/ Dissatisfied
|
45.7 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
1. Dissatisfied or Satisfied/Satisfied
|
54.3 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
2. Very unacceptable/Unacceptable
|
47.9 percentage of participants
|
59.5 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
2.Acceptable or Unacceptable/Acceptable
|
52.1 percentage of participants
|
40.5 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
3.Not at all/Slightly
|
28.2 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
4. Not at all
|
28.3 percentage of participants
|
9.5 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
5.Not at all/Slightly/ Somewhat
|
73.4 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
5. Moderately/Extremely
|
26.7 percentage of participants
|
52.3 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
7. Not at all
|
8.7 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
7. Slightly/Somewhat/Moderately/Extremely
|
91.2 percentage of participants
|
85.8 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
8.Not at all
|
60.9 percentage of participants
|
61.9 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
9.Some of the time/Often/Constantly
|
52.2 percentage of participants
|
51.2 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
10. Some of the time/Often/Constantly
|
52.2 percentage of participants
|
52.4 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
11. Not at all
|
34.8 percentage of participants
|
21.4 percentage of participants
|
|
Percentage of Participants With Facial Redness Questionnaire at Day 8
11.Slightly/Somewhat/Moderately/Extremely
|
65.2 percentage of participants
|
78.5 percentage of participants
|
PRIMARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific categories.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
1. I have no problems in walking about
|
95.7 Percentage of participants
|
92.9 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
1.I have some problems in walking about
|
4.3 Percentage of participants
|
7.1 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
2. I have no problems with self-care
|
97.8 Percentage of participants
|
97.6 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
2. I have some problems washing or dressing myself
|
2.2 Percentage of participants
|
2.4 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
3.I have no problems with performing usual activity
|
91.3 Percentage of participants
|
90.5 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
3.I have some problems with performing usual activity
|
8.7 Percentage of participants
|
9.5 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
4.I have no pain or discomfort
|
58.7 Percentage of participants
|
76.2 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
4.I have moderate pain or discomfort
|
41.3 Percentage of participants
|
21.4 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
4.I have extreme pain or discomfort
|
0 Percentage of participants
|
2.4 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
5.I am not anxious or depressed
|
87.0 Percentage of participants
|
73.8 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
5.I am moderately anxious or depressed
|
10.9 Percentage of participants
|
26.2 Percentage of participants
|
|
EuroQuality of Life-5 Dimensional-3 Level (EQ-5D-3L) Questionnaire at Day 8
5.I am extremely anxious or depressed
|
2.2 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=45 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=41 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Percent Change From Baseline in Total Score of Dermatology Life Quality Index (DLQI) Questionnaire at Day 8
|
-15.4 percent change
Standard Deviation 61.7
|
-32.6 percent change
Standard Deviation 43.7
|
PRIMARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=45 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
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
|
76.0 Score on scale
Standard Deviation 19.3
|
80.2 Score on scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Percentage of Participants With at Least Two Grade Improvement in the Clinician's Erythema Assessment (CEA)
|
47.8 Percentage of participants
|
7.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Percentage of Participants With at Least Two Grade Improvement in the Participant Self-assessment
|
41.3 Percentage of participants
|
23.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 8Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.
Facial inflammatory lesions of rosacea (including papules and pustules) were counted by evaluator.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=46 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=42 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Change From Baseline in Facial Inflammatory Lesion Counts at Day 8
|
0.3 number of lesions
Standard Deviation 2.5
|
0.4 number of lesions
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: From start of study drug administration up to Day 8Population: All Patient Treated (APT) population included all participants enrolled in the study who had received the study treatment at least once.
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.
Outcome measures
| Measure |
Brimonidine Tartrate 0.5% Gel
n=48 Participants
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=44 Participants
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Number of Participants Reported Adverse Events
|
15 Participants
|
9 Participants
|
Adverse Events
Brimonidine Tartrate 0.5% Gel
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brimonidine Tartrate 0.5% Gel
n=48 participants at risk
Participants applied brimonidine tartrate 0.5% gel topically once daily for 8 days.
|
Vehicle
n=44 participants at risk
Participants applied brimonidine tartrate vehicle gel topically once daily for 8 days.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.00%
0/48 • From start of study drug administration up to Day 8
|
4.5%
2/44 • Number of events 2 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/48 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 1 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
8.3%
4/48 • Number of events 5 • From start of study drug administration up to Day 8
|
4.5%
2/44 • Number of events 3 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
4.2%
2/48 • Number of events 9 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 2 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
0.00%
0/44 • From start of study drug administration up to Day 8
|
|
Vascular disorders
Flushing
|
4.2%
2/48 • Number of events 2 • From start of study drug administration up to Day 8
|
0.00%
0/44 • From start of study drug administration up to Day 8
|
|
Nervous system disorders
Hypoesthesia
|
0.00%
0/48 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 1 • From start of study drug administration up to Day 8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 1 • From start of study drug administration up to Day 8
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
0.00%
0/44 • From start of study drug administration up to Day 8
|
|
Infections and infestations
Rash pustular
|
4.2%
2/48 • Number of events 2 • From start of study drug administration up to Day 8
|
0.00%
0/44 • From start of study drug administration up to Day 8
|
|
Nervous system disorders
Headache
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
4.5%
2/44 • Number of events 2 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
6/48 • Number of events 6 • From start of study drug administration up to Day 8
|
4.5%
2/44 • Number of events 2 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
0.00%
0/44 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/48 • Number of events 1 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 1 • From start of study drug administration up to Day 8
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
4.2%
2/48 • Number of events 2 • From start of study drug administration up to Day 8
|
2.3%
1/44 • Number of events 1 • From start of study drug administration up to Day 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreement covered by contract.
- Publication restrictions are in place
Restriction type: OTHER