A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

December 8, 2023 updated by: Galderma R&D

A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

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
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Galderma Research Site
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Galderma Research Site
    • California
      • Redondo Beach, California, United States, 90277
        • Galderma Research Site
      • San Diego, California, United States, 92121
        • Galderma Research Site
      • Vista, California, United States, 92083
        • Galderma Research Site
    • Connecticut
      • Westport, Connecticut, United States, 06880
        • Galderma Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Galderma Research Site
      • Coral Gables, Florida, United States, 33146
        • Galderma Research Site
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Galderma Research Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Galderma Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Galderma Research Site
    • New York
      • New York, New York, United States, 10021
        • Galderma Research Site
    • Texas
      • Spring, Texas, United States, 77388
        • Galderma Research Site
    • Wisconsin
      • Mequon, Wisconsin, United States, 53092
        • Galderma Research 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

Description

Inclusion Criteria:

  • Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
  • Non-pregnant, non-breastfeeding females, over the age of 21.
  • Subjects seeking treatment for the décolletage.

Exclusion Criteria:

  • Known/previous allergy or hypersensitivity to any injectable HA gel or to gram positive bacterial proteins.
  • History of allergy or hypersensitivity to lidocaine or other amidetype anesthetics, or topical anesthetics or nerve blocking agents (if such products are intended to be used for that subject).

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No treatment control
Experimental: GAL1906
Experimental product for correction of wrinkles
Device: GAL1906
hyaluronic acid dermal filler gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.
Time Frame: 12 weeks after initial injection
Responder defined as at least one grade improvement from baseline
12 weeks after initial injection

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)

January 27, 2021

Primary Completion (Actual)

November 22, 2022

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43USRV1906

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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