Trial Outcomes & Findings for Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers (NCT NCT05622851)
NCT ID: NCT05622851
Last Updated: 2026-05-12
Results Overview
Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Immediately post-treatment
Results posted on
2026-05-12
Participant Flow
This is a split-face study, so the total enrollment number was 11.
Unit of analysis: Cheeks
Participant milestones
| Measure |
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).
|
|---|---|
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Overall Study
STARTED
|
11 22
|
|
Overall Study
Restylane Contour
|
11 11
|
|
Overall Study
Juvederm Voluma
|
11 11
|
|
Overall Study
COMPLETED
|
10 20
|
|
Overall Study
NOT COMPLETED
|
1 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers
Baseline characteristics by cohort
| Measure |
Dermal Filler Treatment
n=11 Participants
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.
|
|---|---|
|
Age, Continuous
|
46 years
n=1512 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
9 Participants
n=1512 Participants
|
|
Race/Ethnicity, Customized
Asian
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2 Participants
n=1512 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: Immediately post-treatmentPopulation: 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.
Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.
Outcome measures
| Measure |
Restylane Contour
n=11 Participants
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
|
Juvederm Voluma
n=11 Participants
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
|
|---|---|---|
|
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
Flexibility
|
10 Participants
|
1 Participants
|
|
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
Aggregation
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 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.
Investigator visually reviewed ultrasound scans to determine filler flexibility and aggregation once injected into skin tissues.
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
Flexibility
|
6 Participants
|
2 Participants
|
|
Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound
Aggregation
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 weeksSummary 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.
Outcome measures
| Measure |
Restylane Contour
n=11 Participants
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
|
Juvederm Voluma
n=11 Participants
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
|
|---|---|---|
|
Evaluate Volume Change in the Treated Areas Using 3D Imaging
|
2.97 mL
Interval 2.05 to 3.89
|
3.1 mL
Interval 1.94 to 4.25
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SECONDARY outcome
Timeframe: 6 monthsSummary 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.
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Volume Change in the Treated Areas Using 3D Imaging
|
3.14 mL
Interval 2.17 to 4.12
|
2.68 mL
Interval 1.26 to 4.1
|
SECONDARY outcome
Timeframe: 9 monthsSummary 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.
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Volume Change in the Treated Areas Using 3D Imaging
|
3.05 mL
Interval 1.44 to 4.67
|
2.81 mL
Interval 1.35 to 4.26
|
SECONDARY outcome
Timeframe: 12 monthsSummary 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.
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Volume Change in the Treated Areas Using 3D Imaging
|
2.07 mL
Interval 0.58 to 3.55
|
2.08 mL
Interval 0.64 to 3.52
|
SECONDARY outcome
Timeframe: 4 weeksPercentage 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).
Outcome measures
| Measure |
Restylane Contour
n=11 Participants
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
|
Juvederm Voluma
n=11 Participants
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
|
|---|---|---|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I love how my cheek looks in selfies/photos
|
10 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am camera-ready with my natural contour
|
10 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek feels natural
|
10 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek makes me feel good about myself
|
10 Participants
|
11 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am happy with my contoured cheek
|
10 Participants
|
11 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek looks natural when smiling
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPercentage 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).
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I love how my cheek looks in selfies/photos
|
9 Participants
|
8 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am camera-ready with my natural contour
|
9 Participants
|
8 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek feels natural
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek makes me feel good about myself
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am happy with my contoured cheek
|
9 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek looks natural when smiling
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPercentage 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).
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I love how my cheek looks in selfies/photos
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am camera-ready with my natural contour
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek feels natural
|
9 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek makes me feel good about myself
|
9 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am happy with my contoured cheek
|
9 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek looks natural when smiling
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPercentage 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).
Outcome measures
| Measure |
Restylane Contour
n=10 Participants
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
|
Juvederm Voluma
n=10 Participants
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
|
|---|---|---|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I love how my cheek looks in selfies/photos
|
8 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am camera-ready with my natural contour
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek feels natural
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek makes me feel good about myself
|
8 Participants
|
10 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
I am happy with my contoured cheek
|
9 Participants
|
9 Participants
|
|
Evaluate Subject Satisfaction Using Self-assessment Questionnaire
My cheek looks natural when smiling
|
9 Participants
|
9 Participants
|
Adverse Events
Restylane Contour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Juvederm Voluma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place