Trial Outcomes & Findings for Mirvaso in Use Study (NCT NCT02249065)
NCT ID: NCT02249065
Last Updated: 2022-08-01
Results Overview
The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
205 participants
Primary outcome timeframe
14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)
Results posted on
2022-08-01
Participant Flow
Participant milestones
| Measure |
Mirvaso Gel
Brimonidine Gel (topical emulsion (gel), 0.33% brimonidine, once daily)
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
Treated
|
181
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mirvaso in Use Study
Baseline characteristics by cohort
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
143 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
52.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
181 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)Population: Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment
The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.
Outcome measures
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Clear Skin
|
0 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Almost Clear
|
0 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Mild Erythema
|
7 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Moderate Erythema
|
144 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Severe Erythema
|
30 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 1 (Baseline) · Missing
|
0 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Clear Skin
|
3 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Almost Clear
|
18 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Mild Erythema
|
39 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Moderate Erythema
|
84 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Severe Erythema
|
24 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 7 · Missing
|
13 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Clear Skin
|
4 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Almost Clear
|
25 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Mild Erythema
|
39 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Moderate Erythema
|
86 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Severe Erythema
|
27 Participants
|
|
Pre-Treatment Clinician Erythema Assessment (CEA)
Day 14 · Missing
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days (Day 1 (Baseline) and Day 14/Exit)Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)
Outcome measures
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Subject Facial Redness Questionnaire
Not Bothered (Mean [SD], Day 1, Baseline)
|
75.3 Participants
Standard Deviation 39.4
|
|
Subject Facial Redness Questionnaire
Bothered (Mean [SD], Day 1, Baseline)
|
104.7 Participants
Standard Deviation 40.3
|
|
Subject Facial Redness Questionnaire
Missing (Day 1, Baseline)
|
1 Participants
Standard Deviation 0
|
|
Subject Facial Redness Questionnaire
Not Bothered (Mean [SD], Day 14)
|
112.6 Participants
Standard Deviation 28.9
|
|
Subject Facial Redness Questionnaire
Bothered (Mean [SD], Day 14)
|
67.3 Participants
Standard Deviation 26.2
|
|
Subject Facial Redness Questionnaire
Missing (Day 14)
|
1.1 Participants
Standard Deviation .3
|
SECONDARY outcome
Timeframe: 14 days (Day 14/Exit)Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)
Outcome measures
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Subject Treatment Satisfaction Questionnaire
Satisfied Participants (Mean [SD])
|
127.3 Participants
Standard Deviation 22.2
|
|
Subject Treatment Satisfaction Questionnaire
Dissatisfied Participants (Mean [SD])
|
52.7 Participants
Standard Deviation 22.2
|
|
Subject Treatment Satisfaction Questionnaire
Missing
|
1.0 Participants
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 14 days (Day 1 (Baseline), Day 14/Exit)Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS
Outcome measures
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · None
|
1 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · Very Mild
|
63 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · Mild
|
45 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · None
|
1 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · Very Mild
|
31 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · Mild
|
57 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · Moderate
|
48 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · Severe
|
38 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 1 · Very Severe
|
6 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · Moderate
|
44 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · Severe
|
22 Participants
|
|
Facial Redness Visual Analog Scale (VAS)
Day 14 · Very Severe
|
6 Participants
|
SECONDARY outcome
Timeframe: 14 days (Day 1 (Baseline) and Day 14/Exit)Population: ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment
Change from baseline in facial inflammatory lesion count
Outcome measures
| Measure |
Mirvaso Gel
n=181 Participants
Brimonidine Gel
|
|---|---|
|
Inflammatory Lesions
Day 1: Lesions
|
.6 lesions
Standard Deviation 1.2
|
|
Inflammatory Lesions
Day 14: Lesions
|
1.5 lesions
Standard Deviation 4.4
|
|
Inflammatory Lesions
Day 14: Change From Baseline
|
1 lesions
Standard Deviation 3.9
|
Adverse Events
Mirvaso Gel
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirvaso Gel
n=181 participants at risk
Brimonidine Gel
|
|---|---|
|
Cardiac disorders
myocardial infarction
|
0.55%
1/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
Cardiac disorders
Pericarditis
|
0.55%
1/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.55%
1/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
Other adverse events
| Measure |
Mirvaso Gel
n=181 participants at risk
Brimonidine Gel
|
|---|---|
|
General disorders
condition aggravated
|
18.2%
33/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
General disorders
feeling hot
|
2.2%
4/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
Skin and subcutaneous tissue disorders
rosacea
|
11.6%
21/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.9%
7/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
|
Infections and infestations
nasopharyngitis
|
3.3%
6/181 • 29 Days
Adverse events were recorded for at least 14 days prior to the first treatment application.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60