Volume Deficiency of the Midface
Conditions
Brief summary
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
Detailed description
This is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound. This study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to Restylane Contour or Juvederm Voluma. All subjects are to have midface volume loss and contour deficiency. Eligible subjects are randomized to receive treatment were injected by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator and subject. At the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. At the 6-month, 9-month, and 12-month visits, similar study procedures are performed.
Interventions
DEVICERestylane Contour
Hyaluronic Acid dermal filler
DEVICEJuvederm Voluma
Hyaluronic Acid dermal filler
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects are blinded to treatment assignment to each side of their faces.
Intervention model description
Randomized, split-face, subject-blinded, comparative
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject with midface volume loss and contour deficiency * Ability of giving consent for participation in the study * Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments
Exclusion criteria
* History of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid * Previous permanent or semi-permanent implant in proposed treatment area * Previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit * History of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound | Immediately post-treatment | Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Volume Change in the Treated Areas Using 3D Imaging | 4 weeks | Summary of total volume change in the midface measured by digital 3D photography at each visit. Total volume change corresponds to net volume change from baseline in the treated area. |
| Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 4 weeks | Percentage of response at 4 weeks, 6 months, 9 months, and 12 months, where subjects are asked about their satisfaction with treatment outcome on the midface. Scale consists of 3 preference questions (with no difference option) and 6 satisfaction questions (with strongly agree, agree, neutral, disagree, and strongly disagree). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSteven F Weiner, MD
The Aesthetic Clinique
Participant flow
Pre-assignment details
This is a split-face study, so the total enrollment number was 11.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46 years |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
None listed