GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

August 24, 2022 updated by: Galderma R&D

A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90069
        • Galderma Study Site
      • Sacramento, California, United States, 95816
        • Galderma Study Site
      • Solana Beach, California, United States, 92075
        • Galderma Study Site
    • Florida
      • Miami, Florida, United States, 11137
        • Galderma Study Site
      • West Palm Beach, Florida, United States, 33401
        • Galderma Study Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Galderma Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Galderma Study Site
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Galderma Study Site
    • New York
      • Mount Kisco, New York, United States, 10549
        • Galderma Study Site
      • New York, New York, United States, 10021
        • Galderma Study Site
      • New York, New York, United States, 10028
        • Galderma Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Galderma Study Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Galderma Study Site
      • Dallas, Texas, United States, 75254
        • Galderma Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84101
        • Galderma Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.

Exclusion Criteria:

- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GAL1704 (needle)
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies.
Device: GAL1704
new dermal filler
EXPERIMENTAL: GAL1704 (cannula/needle)
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle.
Device: GAL1704
new dermal filler
ACTIVE_COMPARATOR: Juvederm Voluma
Subjects randomized to control.
Device: Juvederm Voluma
hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
Time Frame: 12 weeks
Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 18, 2018

Primary Completion (ACTUAL)

June 10, 2019

Study Completion (ACTUAL)

May 22, 2020

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 43USV1704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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