Cheek Augmentation
Conditions
Brief summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
Interventions
DEVICERestylane Volyme
Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
DEVICERestylane Lyft Lidocaine
Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
Sponsors
Galderma R&D
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Signed and dated informed consent to participate in the study * Adult women who intend to undergo cheek augmentation
Exclusion criteria
* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics * Subjects with a previous implant other than HA in or near the intended treatment site * Participation in any other clinical study within three (3) months before treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | 4 weeks after last treatment, up to 6 weeks | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Volyme Hyaluronic Acid
Restylane Volyme: Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization). | 30 |
| Restylane Lyft Lidocaine Hyaluronic Acid
Restylane Lyft Lidocaine: Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation). | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Restylane Lyft Lidocaine | Total | Restylane Volyme |
|---|---|---|---|
| Age, Continuous | 49 years | 48.9 years | 48.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST I | 0 Participants | 1 Participants | 1 Participants |
| Fitzpatrick Skin Type (FST) FST II | 7 Participants | 17 Participants | 10 Participants |
| Fitzpatrick Skin Type (FST) FST III | 15 Participants | 27 Participants | 12 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 7 Participants | 14 Participants | 7 Participants |
| Fitzpatrick Skin Type (FST) FST V | 1 Participants | 1 Participants | 0 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 55 Participants | 26 Participants |
| Region of Enrollment Canada | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 1 / 30 | 1 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
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.
Time frame: 4 weeks after last treatment, up to 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Improved | 1 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Worse | 0 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Much improved | 9 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Much worse | 0 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | No change | 0 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Very much worse | 0 Participants |
| Restylane Volyme | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Very much improved | 20 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Very much worse | 0 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Very much improved | 17 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Much improved | 9 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Improved | 3 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | No change | 0 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Worse | 0 Participants |
| Restylane Lyft Lidocaine | Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS | Much worse | 0 Participants |