Clincosm LogoSign in Get a demo

RES: Comparative Ultrasound Analysis of Two Hyaluronic Acid Dermal Fillers

Sponsor
Galderma R&D (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05622851
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
6.5
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Restylane Contour
  • Device: Juvederm Voluma
 N/A

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 24-week visit, similar study procedures are performed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, split-face, subject-blinded, comparativeRandomized, split-face, subject-blinded, comparative
Masking:
Single (Participant)
Masking Description:
Subjects are blinded to treatment assignment to each side of their faces.
Primary Purpose:
Treatment
Official Title:
A Randomized, Split-face Clinical Study on Comparative Ultrasound Analysis of Two Hyaluronic Acid Fillers for Midface Correction
Actual Study Start Date :
Jul 12, 2022
Anticipated Primary Completion Date :
Dec 27, 2022
Anticipated Study Completion Date :
Jan 27, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Device: Restylane Contour
Hyaluronic Acid dermal filler
Active Comparator: 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.

Device: Juvederm Voluma
Hyaluronic Acid dermal filler

Outcome Measures

Primary Outcome Measures

  1. Assess and compare tissue aggregation and visualization of Hyaluronic Acid fillers using ultrasound [Immediately post-treatment, 4 and 24 weeks after baseline]

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

Secondary Outcome Measures

  1. Evaluate subject satisfaction using self-assessment questionnaire [4 and 24 weeks after baseline]

    Percentage of response at week 4 and 24, 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).

  2. Evaluate volume change in the treated areas using 3D imaging [4 weeks after baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Aesthetic Clinique Santa Rosa Beach Florida United States 32459

Sponsors and Collaborators

  • Galderma R&D

Investigators

  • Principal Investigator: Steven F Weiner, MD, The Aesthetic Clinique

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT05622851
Other Study ID Numbers:
  • GLI.04.US.SL.015
First Posted:
Nov 21, 2022
Last Update Posted:
Nov 21, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Nov 21, 2022