Cheek Augmentation, Midface Contour Deficiencies
Conditions
Brief summary
This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.
Interventions
a sterile gel of hyaluronic acid (HA)
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Primary Inclusion Criteria: * Subjects willing to comply with the requirements of the study and providing a signed written informed consent. * Males or non-pregnant, non-breastfeeding females, 22 years of age or older. * Mild to Substantial Midface Volume Loss Primary
Exclusion criteria
* Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins * Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents * Undergone prior surgery to midface
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events [Safety] | 16 weeks | To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Aesthetic Improvement | 16 weeks | To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as Improved or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). |
| Number of Participants That Responded to Treatment | 16 weeks | To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16). |
| Subject Satisfaction | 8 weeks | To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA) | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants |
| Race/Ethnicity, Customized Black/African American | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Race/Ethnicity, Customized White | 43 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 5 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events [Safety]
To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Treatment-Emergent Adverse Events [Safety] | 5 Participants |
Secondary
Number of Participants That Responded to Treatment
To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants That Responded to Treatment | 43 Participants |
Secondary
Number of Participants With Aesthetic Improvement
To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as Improved or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).
Time frame: 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Aesthetic Improvement | 43 Participants |
Secondary
Subject Satisfaction
To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Subject Satisfaction | 77.3 score on a scale | Standard Deviation 23.5 |