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To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Restylane Contour | Active Comparator | Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. |
|
| Juvederm Voluma | Active Comparator | Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restylane Contour | Device | Hyaluronic Acid dermal filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound | Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues. | Immediately post-treatment |
| Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound | Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | 4 weeks |
| Evaluate Volume Change in the Treated Areas Using 3D Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven F Weiner, MD | The Aesthetic Clinique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aesthetic Clinique | Santa Rosa Beach | Florida | 32459 | United States |
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This is a split-face study, so the total enrollment number was 11.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Split-face study design with each treatment was randomized assigned to each side of the face per subject. Restylane Contour: Hyaluronic Acid dermal filler (Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride, mode of administration: injection, dosage: at investigator's discretion for optimal outcome, frequency and duration: injection at baseline and optional touch-up at week 4). Juvederm Voluma: Hyaluronic Acid dermal filler (Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine, mode of administration: injection, dosage: at investigator's discretion for optimal outcome, frequency and duration: injection at baseline and optional touch-up at week 4). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline population demographics were the same for both arms due to split-face study design.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dermal Filler Treatment | Split-face design with one side treated with Restylane Contour and the other side treated with Juvederm Voluma Restylane Contour: Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. Juvederm Voluma: Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound | Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues. | Ultrasound assessments were performed using an 18 MHz Venue Fit (GE HealthCare, Chicago, IL) ultrasonic transducer to assess tissue behavior following treatment, including product integration and flexibility. Ultrasound images were taken on each patient's left and right cheeks (ie, medial zygomatic arch), at neutral expression, and videos of a maximum smiling expression (neutral to maximum smile) were also captured. | Posted | Count of Participants | Participants | Immediately post-treatment |
|
12 months (i.e., from the study start to the study completion)
Throughout the course of the study, all adverse events were monitored and reported on an adverse event CRF/eCRF without omitting any requested and known information.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Restylane Contour | Form: transparent gel of Hyaluronic Acid with the addition of lidocaine hydrochloride. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. Restylane Contour: Hyaluronic Acid dermal filler |
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The sample size was relatively small, which may limit the generalizability of the findings. However, the split- face design enhances the power of the side-by-side product comparisons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thu Q. Nguyen, PhD | Galderma | 8179615495 | thu.nguyen@galderma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2022 | Nov 1, 2022 | Prot_SAP_000.pdf |
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Randomized, split-face, subject-blinded, comparative
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Subjects are blinded to treatment assignment to each side of their faces.
| Juvederm Voluma |
| Device |
Hyaluronic Acid dermal filler |
|
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. |
| 6 months |
| Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | 9 months |
| Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | 12 months |
| Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | 4 weeks |
| Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | 6 months |
| Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | 9 months |
| Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | 12 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Juvederm Voluma | Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. Juvederm Voluma: Hyaluronic Acid dermal filler |
|
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| Secondary | Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | Posted | Mean | 95% Confidence Interval | mL | 4 weeks |
|
|
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| Secondary | Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | Posted | Mean | 95% Confidence Interval | mL | 6 months |
|
|
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| Secondary | Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | Posted | Mean | 95% Confidence Interval | mL | 9 months |
|
|
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| Secondary | Evaluate Volume Change in the Treated Areas Using 3D Imaging | 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. | Posted | Mean | 95% Confidence Interval | mL | 12 months |
|
|
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| Secondary | Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | Posted | Count of Participants | Participants | 6 months |
|
|
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| Secondary | Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | Posted | Count of Participants | Participants | 9 months |
|
|
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| Secondary | Evaluate Subject Satisfaction Using Self-assessment Questionnaire | 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). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound | Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues. | Ultrasound assessments were performed using an 18 MHz Venue Fit (GE HealthCare, Chicago, IL) ultrasonic transducer to assess tissue behavior following treatment, including product integration and flexibility. Ultrasound images were taken on each patient's left and right cheeks (ie, medial zygomatic arch), at neutral expression, and videos of a maximum smiling expression (neutral to maximum smile) were also captured. | Posted | Count of Participants | Participants | 12 months |
|
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Juvederm Voluma | Form: sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogenous gel implant of Hyaluronic Acid crosslinked with BDDE, formulated with lidocaine. Mode of administration: injection Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and optional touch-up at week 4. Juvederm Voluma: Hyaluronic Acid dermal filler | 0 | 11 | 0 | 11 | 0 | 11 |
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| My cheek feels natural |
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| My cheek makes me feel good about myself |
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| I am happy with my contoured cheek |
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| My cheek looks natural when smiling |
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| My cheek feels natural |
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| My cheek makes me feel good about myself |
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| I am happy with my contoured cheek |
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| My cheek looks natural when smiling |
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| My cheek feels natural |
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| My cheek makes me feel good about myself |
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| I am happy with my contoured cheek |
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| My cheek looks natural when smiling |
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| My cheek feels natural |
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| My cheek makes me feel good about myself |
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| I am happy with my contoured cheek |
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| My cheek looks natural when smiling |
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