Midface Volume Deficit
Conditions
Keywords
Hyaluronic acid, midface
Brief summary
This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Midface Volume Deficit and/or Midface Contour Deficiency.
Interventions
DEVICERestylane Volyme
Subcutis injection
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent 2. Men or women aged 18 years of age or older of Chinese origin 3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study 4. Subjects seeking augmentation therapy for the midface 5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator
Exclusion criteria
1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics. 2. Previous surgery or tattoo in the area to be treated 3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim. 4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 9 months before treatment. 5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated. 6. Other condition preventing the subject from entering the study in the Investigator's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders | 6 month | Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A The first 2 eligible subjects for each Treating Investigator will receive treatment as Group A. | 20 |
| Restylane Volyme Treatment Group of Group B Subjects assigned in this group will receive Restylane Volyme treatment at day 1. | 111 |
| Control Group of Group B Subjects assigned in this group will receive no treatment at day 1, but at 6m visit. | 37 |
| Total | 168 |
Baseline characteristics
| Characteristic | Group A | Restylane Volyme Treatment Group of Group B | Control Group of Group B | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 109 Participants | 37 Participants | 166 Participants |
| Age, Continuous | 46.3 years STANDARD_DEVIATION 9.7 | 41.3 years STANDARD_DEVIATION 10.2 | 41.2 years STANDARD_DEVIATION 10 | 41.3 years STANDARD_DEVIATION 10.1 |
| Race/Ethnicity, Customized Chinese Han | 20 Participants | 111 Participants | 37 Participants | 168 Participants |
| Region of Enrollment China | 20 participants | 111 participants | 37 participants | 168 participants |
| Sex: Female, Male Female | 20 Participants | 104 Participants | 32 Participants | 156 Participants |
| Sex: Female, Male Male | 0 Participants | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 111 | 0 / 37 |
| other Total, other adverse events | 0 / 20 | 0 / 111 | 0 / 37 |
| serious Total, serious adverse events | 1 / 20 | 1 / 111 | 0 / 37 |
Outcome results
Primary
Percentage of Responders
Percentage of responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face concurrently, as measured by the blinded evaluator at 6 months after last treatment in Treatment Group, and at 6 months after randomization in Control Group. MMVS is a Four-Point scale that assesses the fullness of the midface from Fairly Full (1) to Substantial Loss of Fullness (4) as described below. The blinded evaluator and treating investigator will rate the subject's right and left midface for severity of volume deficiency using the MMVS at all applicable study visits.
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Percentage of Responders | 80 percentage of subjects |
| Group B-treatment Arm | Percentage of Responders | 87.2 percentage of subjects |
| Group B-control Arm | Percentage of Responders | 76.7 percentage of subjects |