N/A
N=11
Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers
Volume Deficiency of the Midface
Bottom Line
View on ClinicalTrials.gov: NCT05622851 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound — 10; 1; 7; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restylane Contour (Device); Juvederm Voluma (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound |
6; 2; 1; 8 | — |
| PRIMARY Assess and Compare Tissue Aggregation and Visualization of Hyaluronic Acid Fillers by Investigator Using Ultrasound |
6; 2; 1; 8 | — |
| SECONDARY Evaluate Volume Change in the Treated Areas Using 3D Imaging |
2.07; 2.08 | — |
| SECONDARY Evaluate Volume Change in the Treated Areas Using 3D Imaging |
2.07; 2.08 | — |
| SECONDARY Evaluate Volume Change in the Treated Areas Using 3D Imaging |
2.07; 2.08 | — |
| SECONDARY Evaluate Volume Change in the Treated Areas Using 3D Imaging |
2.07; 2.08 | — |
| SECONDARY Evaluate Subject Satisfaction Using Self-assessment Questionnaire |
8; 9; 9; 9; 9; 9 | — |
| SECONDARY Evaluate Subject Satisfaction Using Self-assessment Questionnaire |
8; 9; 9; 9; 9; 9 | — |
| SECONDARY Evaluate Subject Satisfaction Using Self-assessment Questionnaire |
8; 9; 9; 9; 9; 9 | — |
| SECONDARY Evaluate Subject Satisfaction Using Self-assessment Questionnaire |
8; 9; 9; 9; 9; 9 | — |
Summary
To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05622851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.