Facial Tissue Augmentation
Conditions
Brief summary
A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.
Interventions
DEVICEHA experimental
DEVICEHA comparator
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provide a signed and dated informed consent to participate in the study including release of copyright of images * Man or woman aged 18 years or older * Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable HA gel * History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment * Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment * Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated * The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders in Midface Fullness Using Photo Scale | 3 months | Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders in Midface Fullness Using Photo Scale | 15 months | Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Both Cheeks Group HA product under investigation in both cheeks | 36 |
| Split-face Group HA product under investigation in one cheek and a comparator in the other cheek. | 12 |
| Total | 48 |
Baseline characteristics
| Characteristic | Both Cheeks Group | Split-face Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 11 Participants | 46 Participants |
| Age, Continuous | 41.1 years STANDARD_DEVIATION 11 | 44.8 years STANDARD_DEVIATION 10.2 | 42 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 11 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Sweden | 36 Participants | 12 Participants | 48 Participants |
| Sex: Female, Male Female | 34 Participants | 12 Participants | 46 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 12 |
| other Total, other adverse events | 23 / 36 | 7 / 12 |
| serious Total, serious adverse events | 4 / 36 | 1 / 12 |
Outcome results
Primary
Percentage of Responders in Midface Fullness Using Photo Scale
Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
Time frame: 3 months
Population: The primary objective applied to the group treated with the investigational HA product in both cheeks.~Only exploratory objective applied to the split-face group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 93.5 percentage of participants |
Secondary
Percentage of Responders in Midface Fullness Using Photo Scale
Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.
Time frame: 15 months
Population: Number of participants with available data varied during the study. The secondary objective applied to the group treated with the investigational HA product in both cheeks.~Only exploratory objective applied to the split-face group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 4 weeks after last treatment | 88.2 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 3 months | 93.5 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 6 months | 90 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 9 months | 81.5 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 12 months | 43.3 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 15 months | 25 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 4 weeks after re-treatment | 100 percentage of participants |
| Both Cheeks Group | Percentage of Responders in Midface Fullness Using Photo Scale | 3 months after re-treatment | 100 percentage of participants |