Cheek Augmentation
Conditions
Brief summary
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
Interventions
DEVICEGAL1704
new dermal filler
DEVICEJuvederm Voluma
hyaluronic acid
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
Exclusion criteria
\- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) | 12 weeks | Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GAL1704 (Needle) Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies | 142 |
| GAL1704 (Cannula) GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle | 60 |
| Juvederm Voluma Subjects randomized to control. | 68 |
| Total | 270 |
Baseline characteristics
| Characteristic | Total | Juvederm Voluma | GAL1704 (Cannula) | GAL1704 (Needle) |
|---|---|---|---|---|
| Age, Continuous | 52.7 years | 54.7 years | 52.1 years | 52.7 years |
| Fitzpatrick Skin Type (FST) FST I | 6 Participants | 1 Participants | 1 Participants | 4 Participants |
| Fitzpatrick Skin Type (FST) FST II | 72 Participants | 23 Participants | 9 Participants | 40 Participants |
| Fitzpatrick Skin Type (FST) FST III | 120 Participants | 28 Participants | 27 Participants | 65 Participants |
| Fitzpatrick Skin Type (FST) FST IV | 34 Participants | 9 Participants | 8 Participants | 17 Participants |
| Fitzpatrick Skin Type (FST) FST V | 14 Participants | 3 Participants | 3 Participants | 8 Participants |
| Fitzpatrick Skin Type (FST) FST VI | 24 Participants | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 7 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 226 Participants | 57 Participants | 44 Participants | 125 Participants |
| Region of Enrollment United States | 270 participants | 68 participants | 60 participants | 142 participants |
| Sex: Female, Male Female | 242 Participants | 58 Participants | 55 Participants | 129 Participants |
| Sex: Female, Male Male | 28 Participants | 10 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 142 | 0 / 60 | 0 / 68 |
| other Total, other adverse events | 6 / 141 | 0 / 60 | 13 / 68 |
| serious Total, serious adverse events | 0 / 141 | 1 / 60 | 2 / 68 |
Outcome results
Primary
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
Time frame: 12 weeks
Population: Per protocol population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GAL1704 (Needle) | Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) | -1.4 score on a scale |
| GAL1704 (Cannula/Needle) | Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) | -0.1 score on a scale |
| Juvederm Voluma | Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) | -1.3 score on a scale |