Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

Volume Deficiency of the Midface Clinical Trial

— RES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622851
• Other study ID #: GLI.04.US.SL.015
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: December 6, 2023

Study information

• Verified date: October 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 6, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Volume Deficiency of the Midface

Intervention

Device:
• Restylane Contour
Hyaluronic Acid dermal filler
• Juvederm Voluma
Hyaluronic Acid dermal filler

Locations

Country	Name	City	State
United States	The Aesthetic Clinique	Santa Rosa Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately post-treatment, 4 weeks, 6 months, 9 months, and 12 months after baseline
Secondary	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).	4 weeks, 6 months, 9 months, and 12 months after baseline
Secondary	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.	4 weeks, 6 months, 9 months, and 12 months after baseline