WrinkleNCT04717934

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

A study testing GAL1906 in people with Wrinkle, run by Galderma R&D at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 22 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Wrinkle
What is being tested?: GAL1906
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 14 sitesUnited States
Study dates: 8 Feb 2021to 13 Jun 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Wrinkle
Being tested: GAL1906
Keywords: Wrinkles in the Décolletage Area

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GAL1906Device
hyaluronic acid dermal filler gel

Study groups in NCT04717934
Study group	Role	What they receive
GAL1906	Experimental	Experimental product for correction of wrinkles Receives: 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12
Responder was defined as participants having at least one grade improvement from baseline on the Galderma decolletage scale. Galderma Decolletage Scale was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area where: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher scores indicated more severe lines and wrinkles in the décolletage area. Percentage of responders as assessed live by the blinded evaluator has been reported for this outcome measure. 95% confidence interval was calculated using Clopper-Pearson method.
Measured: At Week 12
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist
The number of participants with interference in breast images obtained using any diagnostic image modality (such as mammogram, breast ultrasound, breast magnetic resonance imaging [MRI], biopsy, and other procedure)as determined by adjudicated radiologist is reported.
Measured: During treatment (anytime between Day 1 to Week 8 of main study), post first treatment on Day 1 and post last treatment (up to 12 months after receiving GAL1906 treatment in the Main study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202113 Jun 2025

First posted22 Jan 2021
Study start8 Feb 2021
Primary completion26 May 2025
Study completion13 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for WrinkleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04717934
Sponsor's protocol ID: 43USRV1906
Status last verified: Jul 2026
First submitted: 16 Jan 2021
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04717934
Acronym / sponsor ID: 43USRV1906
Conditions: Wrinkle
Keywords: Wrinkles in the Décolletage Area
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 8 Feb 2021 (actual)
Primary completion: 26 May 2025 (actual)
Study completion: 13 Jun 2025 (actual)
First posted: 22 Jan 2021 (actual)
Results: Posted 15 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
GAL1906	Experimental	Device: GAL1906Experimental product for correction of wrinkles
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)

Who may qualify

Ages: 22 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GAL1906hyaluronic acid dermal filler gel	Device	GAL1906

Primary outcome

Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12
Time frame: At Week 12
Responder was defined as participants having at least one grade improvement from baseline on the Galderma decolletage scale. Galderma Decolletage Scale was a validated 5-point scale used to assess the severity of lines and wrinkles in the décolletage area where: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (very severe). Higher scores indicated more severe lines and wrinkles in the décolletage area. Percentage of responders as assessed live by the blinded evaluator has been reported for this outcome measure. 95% confidence interval was calculated using Clopper-Pearson method.
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist
Time frame: During treatment (anytime between Day 1 to Week 8 of main study), post first treatment on Day 1 and post last treatment (up to 12 months after receiving GAL1906 treatment in the Main study)
The number of participants with interference in breast images obtained using any diagnostic image modality (such as mammogram, breast ultrasound, breast magnetic resonance imaging [MRI], biopsy, and other procedure)as determined by adjudicated radiologist is reported.

Results and safety

Results posted to the registry on 15 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main Study: GAL1906 Group	163	149
Main Study: No Treatment Group	48	44
Sub-study: No Treatment	0	0

Primary outcome: Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12

Time frame: At Week 12. Number (95% Confidence Interval). Unit: percentage of Participants

Measure	GAL1906 Group n = 144	No Treatment Group n = 48
Value	73.6 (65.6 to 80.6)	18.8 (8.9 to 32.6)

GAL1906 Group vs No Treatment Group: Percentage difference: 54.9 (95% CI 41.7 to 68.0), p < .001, Fisher's Exact Test

Population analysed: Intent-to-treat (ITT) population Included all participants who were randomized and were analyzed according to the treatment they were randomized to.

Primary outcome: Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist

Time frame: During treatment (anytime between Day 1 to Week 8 of main study), post first treatment on Day 1 and post last treatment (up to 12 months after receiving GAL1906 treatment in the Main study). Count of participants. Unit: Participants

Measure	Sub- Study: No Treatment Group n = 49
During Treatment Image	0
Post Last-Treatment Image	0
Post First-Treatment Image (Total)	0

Population analysed: The Sub-study Safety population included all participants who were treated with GAL1906 in the main study, agreed to participate in the sub-study, and had collection of mammographic data after first treatment with GAL1906. Here, "Overall Number of Participants Analyzed" signifies the participants who were evaluable for this outcome measure and "Number Analyzed" signifies participants in the specific rows.

Adverse events

Time frame: Main study: From baseline (Day 1) up to Week 32 (no treatment group) and up to Week 56 (GAL1906 group) Sub-Study: Within 12 months after receiving last GAL1906 treatment in the Main study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main Study: GAL1906 Group	2 of 163 (1.2%)	10 of 163 (6.1%)	0 of 163
Main Study: No Treatment Group	1 of 48 (2.1%)	2 of 48 (4.2%)	0 of 48
Sub-study: No Treatment Group	0 of 66 (0%)	0 of 66 (0%)	0 of 66

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GAL1906 in people with Wrinkle, run by Galderma R&D at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12 (time frame: At Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04717934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.