Midface Volume Deficit
Conditions
Keywords
hyaluronic acid, midface
Brief summary
This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.
Interventions
Intradermal 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 12 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 |
|---|---|---|
| Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale | 6 month | The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months. Medicis Midface Volume Scale (MMVS) is a 4-grade scale 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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restylane Perlane Lidocaine Single injection and optional touch up injection with Restylane Perlane Lidocaine in Midface
Restylane Perlane Lidocaine: Intradermal injection | 132 |
| No Intervention Arm No treatment | 37 |
| Total | 169 |
Baseline characteristics
| Characteristic | Restylane Perlane Lidocaine | No Intervention Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 132 Participants | 36 Participants | 168 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 10.3 | 48 years STANDARD_DEVIATION 11.1 | 46 years STANDARD_DEVIATION 10.4 |
| Race/Ethnicity, Customized Asian | 132 Participants | 37 Participants | 169 Participants |
| Region of Enrollment China | 132 participants | 37 participants | 169 participants |
| Sex: Female, Male Female | 119 Participants | 35 Participants | 154 Participants |
| Sex: Female, Male Male | 13 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 37 |
| other Total, other adverse events | 0 / 110 | 0 / 37 |
| serious Total, serious adverse events | 0 / 110 | 0 / 37 |
Outcome results
Primary
Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale
The primary objective is to demonstrate superiority of Perlane-Lido relative to no-treatment in the treatment of Midface volume Deficit and/or Midface Contour Deficiency by comparing the percent responders, defined by at least 1 point improvement from baseline on the MMVS on both sides of the face, as measured by blinded evaluator at 6 months. Medicis Midface Volume Scale (MMVS) is a 4-grade scale 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. 1. Fairly full midface 2. Mild loss of fullness in midface area 3. Moderate loss of fullness with slight hollowing below malar prominence 4. Substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence
Time frame: 6 month
Population: All summaries will be done separately for Group A and B. For statistical inference,only Group B will be used.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Restylane Perlane Lidocaine | Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale | 67 Participants |
| No Intervention Arm | Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale | 8 Participants |