NCT04717934

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

4.3 years

First QC Date

January 16, 2021

Results QC Date

May 26, 2026

Last Update Submit

July 14, 2026

Conditions

Wrinkle

Keywords

Wrinkles in the Décolletage Area

Study Arms (3)

GAL1906

EXPERIMENTAL

Experimental product for correction of wrinkles

Device: GAL1906

Control

NO INTERVENTION

No treatment control

Sub-Study

NO INTERVENTION

FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)

Interventions

GAL1906DEVICE

hyaluronic acid dermal filler gel

GAL1906

Eligibility Criteria

Age22 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 was willing to comply with the requirements of the study and provide a signed written informed consent.
  • Subject had 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 was pregnant or nursing AND has no mammogram taken post GAL1906 treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Galderma Research Site

Birmingham, Alabama, 35209, United States

Location

Galderma Research Site

Scottsdale, Arizona, 85255, United States

Location

Galderma Research Site

Redondo Beach, California, 90277, United States

Location

Galderma Research Site

San Diego, California, 92121, United States

Location

Galderma Research Site

Vista, California, 92083, United States

Location

Galderma Research Site

Westport, Connecticut, 06880, United States

Location

Galderma Research Site

Boynton Beach, Florida, 33472, United States

Location

Galderma Research Site

Coral Gables, Florida, 33146, United States

Location

Galderma Research Site

Alpharetta, Georgia, 30022, United States

Location

Galderma Research Site

Chicago, Illinois, 60654, United States

Location

Galderma Research Site

Baltimore, Maryland, 21208, United States

Location

Galderma Research Site

New York, New York, 10021, United States

Location

Galderma Research Site

Spring, Texas, 77388, United States

Location

Galderma Research Site

Mequon, Wisconsin, 53092, United States

Location

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 8, 2021

Primary Completion

May 26, 2025

Study Completion

June 13, 2025

Last Updated

July 15, 2026

Results First Posted

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(14)