Trial Outcomes & Findings for Mirvaso® Utilisation and Patient Satisfaction Evaluation (MUSE) (NCT NCT02637232)
NCT ID: NCT02637232
Last Updated: 2021-05-28
Results Overview
Recruitment status
COMPLETED
Target enrollment
301 participants
Primary outcome timeframe
Week 4
Results posted on
2021-05-28
Participant Flow
Participant milestones
| Measure |
Mirvaso® / Onreltea TM
Mirvaso® / Onreltea TM
|
|---|---|
|
Overall Study
STARTED
|
301
|
|
Overall Study
COMPLETED
|
246
|
|
Overall Study
NOT COMPLETED
|
55
|
Reasons for withdrawal
| Measure |
Mirvaso® / Onreltea TM
Mirvaso® / Onreltea TM
|
|---|---|
|
Overall Study
Lost to Follow-up
|
42
|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
patient 's decision
|
2
|
Baseline Characteristics
Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
Baseline characteristics by cohort
| Measure |
Mirvaso® / Onreltea TM
n=301 Participants
Mirvaso® / Onreltea TM
|
|---|---|
|
Age, Continuous
|
48.4 Years
STANDARD_DEVIATION 14.7 • n=301 Participants
|
|
Sex: Female, Male
Female
|
218 Participants
n=301 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=301 Participants
|
|
Duration of rosacea
|
5.5 Years
STANDARD_DEVIATION 7.9 • n=301 Participants
|
|
Previous therapies in the last 2 years
|
150 Participants
n=301 Participants
|
|
Subject previously prescribed by Mirvaso
|
65 Participants
n=301 Participants
|
|
Severity of facial erythema (by physician)
Mild
|
68 Participants
n=301 Participants
|
|
Severity of facial erythema (by physician)
Moderate
|
179 Participants
n=301 Participants
|
|
Severity of facial erythema (by physician)
Severe
|
53 Participants
n=301 Participants
|
|
Severity of facial erythema (by physician)
Missing
|
1 Participants
n=301 Participants
|
|
Severity of facial erythema (by subject)
Mild
|
58 Participants
n=301 Participants
|
|
Severity of facial erythema (by subject)
Moderate
|
169 Participants
n=301 Participants
|
|
Severity of facial erythema (by subject)
Severe
|
73 Participants
n=301 Participants
|
|
Severity of facial erythema (by subject)
Missing
|
1 Participants
n=301 Participants
|
|
Additional signs and Symptoms
Flushing present
|
250 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Papules and Pustules
|
127 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Skin burning & stinging sensation
|
151 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Rhinophyma
|
16 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Ocular manifestation
|
29 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Telangiectasis
|
205 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
|
Additional signs and Symptoms
Other signs and symptoms
|
1 Participants
n=298 Participants • Each subject can present several signs and symptoms. Here, number analyzed=participants with available data for specified categories.
|
PRIMARY outcome
Timeframe: Week 4Population: Analysis was performed on total population. Here, "Overall Number of Participants Analyzed" = participants with available data for this outcome measure.
Outcome measures
| Measure |
Mirvaso® / Onreltea TM
n=237 Participants
Mirvaso® / Onreltea TM
|
|---|---|
|
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Somewhat dissatisfied
|
31 Participants
|
|
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Very dissatisfied
|
27 Participants
|
|
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Very satisfied
|
55 Participants
|
|
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Somewhat satisfied
|
86 Participants
|
|
Satisfaction Among Patients to Whom Mirvaso®/OnrelteaTM is Prescribed Question
Neither satisfied nor dissatisfied
|
38 Participants
|
Adverse Events
Mirvaso® / Onreltea TM
Serious events: 1 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirvaso® / Onreltea TM
n=259 participants at risk
Mirvaso® / Onreltea TM
|
|---|---|
|
Cardiac disorders
ANGINA PECTORIS
|
0.39%
1/259 • Number of events 1 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Vascular disorders
AORTIC ECTASIA
|
0.39%
1/259 • Number of events 1 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Vascular disorders
STENOSIS OF ILIACA EXTERNAL
|
0.39%
1/259 • Number of events 1 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Vascular disorders
RIVA STENOSIS
|
0.39%
1/259 • Number of events 1 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
Other adverse events
| Measure |
Mirvaso® / Onreltea TM
n=259 participants at risk
Mirvaso® / Onreltea TM
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.4%
32/259 • Number of events 36 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.7%
7/259 • Number of events 7 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
3.1%
8/259 • Number of events 8 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
12.7%
33/259 • Number of events 36 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
6.6%
17/259 • Number of events 17 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Vascular disorders
Flushing
|
11.6%
30/259 • Number of events 30 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
2.7%
7/259 • Number of events 10 • From Baseline (Day 0) up to study follow-up visit at Week 4 (Day 31).
Analysis was performed on safety population that comprised of subjects included and with at least a post-Baseline visit or information regarding the adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This is an agreement between the PI and sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Disclosure agreement is covered by a contract.
- Publication restrictions are in place
Restriction type: OTHER