Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906

Main Study: 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 Sub-study: A Follow-up Sub-study to Assess Interpretation of Mammograms Following Treatment for Correction of Wrinkles in the Décolletage Area in the Investigational Study 43USRV1906

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

Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.

Study Overview

• Status: Completed
• Conditions: Wrinkle
• Intervention / Treatment: Device: GAL1906

• Study Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Main study:

• 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.

Inclusion Criteria for Sub-study:

• Subject is willing to comply with the requirements of the study and provide a signed written informed consent.
• Subject has received treatment with GAL1906 in the main protocol.

Exclusion Criteria for Main study:

• 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).

Exclusion Criteria for Sub-study:

• Subject is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

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; Other Names: Sub-study
No Intervention: Sub-Study; FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12.	Responder defined as at least one grade improvement from baseline	12 weeks after initial injection
Sub-study: Incidence of Breast Image Interference, as Determined by Adjudicated Radiologist	Incidence of breast image interference, as determined by adjudicated radiologist, leading to potential misdiagnosis due to interference of GAL1906, by evaluation of all performed and collected diagnostic methods as well as comparison of post-treatment mammograms to pretreatment mammograms per subject if applicable.	Through the study completion, within 3 months of study start (approximately)

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Actual): May 26, 2025
• Study Completion (Actual): June 13, 2025

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 (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Wrinkles in the Décolletage Area
• 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