Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

Galderma R&D11 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Volume Deficiency of the Midface

Interventions

Restylane ContourDEVICE

Hyaluronic Acid dermal filler

Juvederm VolumaDEVICE

Hyaluronic Acid dermal filler

Eligibility

Sex: ALLMin age: 22 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

The Aesthetic Clinique

Santa Rosa Beach, Florida, United States

Outcomes

Primary Outcomes

Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound

Change in filler properties within the skin tissues. Filler properties include size, shape, and aggregation at different facial expressions.

Time frame: Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline

Secondary Outcomes

Evaluate subject satisfaction using self-assessment questionnaire

Percentage 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).

Time frame: 4 weeks, 6 months, 9 months, and 12 months after baseline

Evaluate volume change in the treated areas using 3D imaging

Summary 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.

Time frame: 4 weeks, 6 months, 9 months, and 12 months after baseline

Data from ClinicalTrials.gov

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