Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

NCT ID: NCT05622851

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2023-12-06

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Restylane Contour

Intervention Type: DEVICE

Hyaluronic Acid dermal filler

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.

Group Type: ACTIVE_COMPARATOR

Juvederm Voluma

Intervention Type: DEVICE

Hyaluronic Acid dermal filler

Interventions

Restylane Contour

Hyaluronic Acid dermal filler

Intervention Type: DEVICE

Juvederm Voluma

Hyaluronic Acid dermal filler

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven F Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

The Aesthetic Clinique

Locations

The Aesthetic Clinique

Santa Rosa Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GLI.04.US.SL.015

Identifier Type: -

Identifier Source: org_study_id