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
1 other identifier
interventional
211
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
February 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2025
CompletedAugust 17, 2025
August 1, 2025
3 months
January 16, 2021
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (3)
GAL1906
EXPERIMENTALExperimental product for correction of wrinkles
Control
NO INTERVENTIONNo treatment control
Sub-Study
NO INTERVENTIONFDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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).
- Subject is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (14)
Galderma Research Site
Birmingham, Alabama, 35209, United States
Galderma Research Site
Scottsdale, Arizona, 85255, United States
Galderma Research Site
Redondo Beach, California, 90277, United States
Galderma Research Site
San Diego, California, 92121, United States
Galderma Research Site
Vista, California, 92083, United States
Galderma Research Site
Westport, Connecticut, 06880, United States
Galderma Research Site
Boynton Beach, Florida, 33472, United States
Galderma Research Site
Coral Gables, Florida, 33146, United States
Galderma Research Site
Alpharetta, Georgia, 30022, United States
Galderma Research Site
Chicago, Illinois, 60654, United States
Galderma Research Site
Baltimore, Maryland, 21208, United States
Galderma Research Site
New York, New York, 10021, United States
Galderma Research Site
Spring, Texas, 77388, United States
Galderma Research Site
Mequon, Wisconsin, 53092, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2021
First Posted
January 22, 2021
Study Start
February 11, 2025
Primary Completion
May 26, 2025
Study Completion
June 13, 2025
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share