NCT05622851

Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Volume Deficiency of the Midface

Interventions

Type	Name	Description
DEVICE	Restylane Contour	Hyaluronic Acid dermal filler
DEVICE	Juvederm Voluma	Hyaluronic Acid dermal filler

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-09-25
• Completion: 2023-12-06
• First posted: 2022-11-21
• Last updated: 2024-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study