Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers (RES)

Galderma

Status: Completed

Conditions: Volume Deficiency of the Midface

Treatments: Device: Juvederm Voluma; Device: Restylane Contour

Study type: Interventional

Funder types: Industry

Identifiers

NCT05622851

GLI.04.US.SL.015

Details and patient eligibility

About

To assess and compare tissue aggregation and visualization of two Hyaluronic Acid fillers via ultrasound

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Restylane Contour

Active Comparator group

Description:

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.

Treatment:

Device: Restylane Contour

Juvederm Voluma

Active Comparator group

Description:

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.

Treatment:

Device: Juvederm Voluma