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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05622851
Other study ID # GLI.04.US.SL.015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03869450 - A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers N/A
Active, not recruiting NCT05963204 - A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator With a Skincare Regimen N/A
Recruiting NCT06351358 - Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies N/A
Recruiting NCT05853224 - An Interventional Study to Evaluate the Safety and Performance of Crosslinked Hyaluronic Acid Hydrogel N/A