Trial Outcomes & Findings for A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers (NCT NCT03869450)
NCT ID: NCT03869450
Last Updated: 2022-08-26
Results Overview
A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
Restylane Volyme
According to the treatment algorithm, treated with Restylane Volyme
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
According to the treatment algorithm, treated with Restylane Defyne
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
According to the treatment algorithm, treated with Restylane Lyft Lidocaine
Restylane Lyft Lidocaine: Hyaluronic based filler
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
25
|
34
|
|
Overall Study
COMPLETED
|
30
|
23
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
Baseline characteristics by cohort
| Measure |
Restylane Volyme
n=31 Participants
According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
n=25 Participants
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
n=34 Participants
According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler
|
Total
n=90 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
|
31 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeksA blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.
Outcome measures
| Measure |
Restylane Volyme
n=31 Participants
According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
n=24 Participants
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
n=34 Participants
According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler
|
|---|---|---|---|
|
Percentage of Participants With Aesthetic Improvement of Midface
|
96.8 percentage of participants
Interval 83.3 to 99.9
|
100 percentage of participants
Interval 85.8 to 100.0
|
97.1 percentage of participants
Interval 84.7 to 99.9
|
SECONDARY outcome
Timeframe: 8 weeksA blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness. Improved midface volume was defined as at least a 1-grade decrease from baseline.
Outcome measures
| Measure |
Restylane Volyme
n=31 Participants
According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
n=24 Participants
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
n=34 Participants
According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler
|
|---|---|---|---|
|
Percentage of Participants With Improved Midface Volume
|
90.3 percentage of participants
Interval 74.2 to 98.0
|
87.5 percentage of participants
Interval 67.6 to 97.3
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
SECONDARY outcome
Timeframe: 8 weeksBlinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question "Are the subject's treatment results natural looking?". Having natural treatment results is defined as being assessed with answers Strongly agree or Agree.
Outcome measures
| Measure |
Restylane Volyme
n=31 Participants
According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
n=24 Participants
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
n=33 Participants
According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler
|
|---|---|---|---|
|
Percentage of Participants Assessed as Having Natural Treatment Results
|
93.5 percentage of participants
|
100 percentage of participants
|
93.9 percentage of participants
|
Adverse Events
Restylane Volyme
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Restylane Defyne
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Restylane Lyft Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Volyme
n=31 participants at risk
According to the treatment algorithm, Restylane Volyme was chosen for participants whose primary need for treatment was volume deficiency.
Restylane Volyme: Hyaluronic based filler
|
Restylane Defyne
n=25 participants at risk
According to the treatment algorithm, Restylane Defyne was chosen for participants with thin tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Defyne: Hyaluronic based filler
|
Restylane Lyft Lidocaine
n=34 participants at risk
According to the treatment algorithm, Restylane Lyft Lidocaine was chosen for participants with thick tissue coverage and whose primary need for treatment was lifting or contouring.
Restylane Lyft Lidocaine: Hyaluronic based filler
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
9.7%
3/31 • Number of events 3 • 24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.
|
0.00%
0/25 • 24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.
|
0.00%
0/34 • 24-27 weeks (depending on how long screening period), from signature of informed consent to last study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place