Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkle… (NCT04717934) | Clinical Trial Compass
CompletedNot Applicable
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
United States211 participantsStarted 2021-02-08
Plain-language 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.
Who can participate
Age range
22 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
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 was pregnant or nursing AND has no mammogram taken post GAL1906 treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Responders on the Galderma Decolletage Scale, as Assessed Live by the Blinded Evaluator, at Week 12
Timeframe: At Week 12
2
Sub-study: Number of Participants With Breast Image Interference, as Determined by Adjudicated Radiologist
Timeframe: 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)