Trial Outcomes & Findings for Study to Evaluate Satisfaction After Treatment With Restylane (NCT NCT04638816)
NCT ID: NCT04638816
Last Updated: 2024-03-06
Results Overview
The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 weeks after last treatment, up to 6 weeks
Results posted on
2024-03-06
Participant Flow
Participant milestones
| Measure |
Restylane Volyme
Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
|
Restylane Lyft Lidocaine
Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Restylane Volyme
Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
|
Restylane Lyft Lidocaine
Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Evaluate Satisfaction After Treatment With Restylane
Baseline characteristics by cohort
| Measure |
Restylane Volyme
n=30 Participants
Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
|
Restylane Lyft Lidocaine
n=30 Participants
Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.8 years
n=5 Participants
|
49 years
n=7 Participants
|
48.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after last treatment, up to 6 weeksThe 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
Outcome measures
| Measure |
Restylane Volyme
n=30 Participants
Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
|
Restylane Lyft Lidocaine
n=29 Participants
Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
|
|---|---|---|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Very much improved
|
20 Participants
|
17 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Much improved
|
9 Participants
|
9 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Improved
|
1 Participants
|
3 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
No change
|
0 Participants
|
0 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Worse
|
0 Participants
|
0 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Much worse
|
0 Participants
|
0 Participants
|
|
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
Very much worse
|
0 Participants
|
0 Participants
|
Adverse Events
Restylane Volyme
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Restylane Lyft Lidocaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Restylane Volyme
n=30 participants at risk
Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
|
Restylane Lyft Lidocaine
n=30 participants at risk
Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
3.3%
1/30 • Number of events 1 • 4 months
|
3.3%
1/30 • Number of events 4 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
- Publication restrictions are in place
Restriction type: OTHER