Trial Outcomes & Findings for The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face (NCT NCT01559064)
NCT ID: NCT01559064
Last Updated: 2014-10-13
Results Overview
Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy
Recruitment status
COMPLETED
Target enrollment
115 participants
Primary outcome timeframe
3 weeks
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
Age Group A
Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group B
Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group C
Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
40
|
59
|
|
Overall Study
COMPLETED
|
15
|
39
|
57
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Volumizing Effect of Juvéderm VOLUMA® in the Mid-Face
Baseline characteristics by cohort
| Measure |
Age Group A
n=16 Participants
Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group B
n=40 Participants
Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group C
n=59 Participants
Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 2.8 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
25 participants
n=7 Participants
|
33 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 weeksSubject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy
Outcome measures
| Measure |
Age Group A
n=16 Participants
Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group B
n=39 Participants
Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group C
n=57 Participants
Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
|---|---|---|---|
|
Subject Experience Measured by Patient Satisfaction Questionnaire
|
1.94 Units on a scale
Standard Deviation .68
|
1.62 Units on a scale
Standard Deviation .78
|
1.51 Units on a scale
Standard Deviation .57
|
Adverse Events
Age Group A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Age Group B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Age Group C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age Group A
n=16 participants at risk
Subjects 30 to 40 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group B
n=39 participants at risk
Subjects 40 to 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
Age Group C
n=57 participants at risk
Subjects over 50 years old
Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Injection site hematoma
|
0.00%
0/16
|
2.6%
1/39 • Number of events 1
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
Injection site edema
|
0.00%
0/16
|
0.00%
0/39
|
1.8%
1/57 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injection site pain
|
0.00%
0/16
|
0.00%
0/39
|
1.8%
1/57 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pain
|
6.2%
1/16 • Number of events 1
|
0.00%
0/39
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
Swelling
|
6.2%
1/16 • Number of events 1
|
0.00%
0/39
|
0.00%
0/57
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place