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Evaluating GAL1906 for treating wrinkles in the décolletage area

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

NA · Galderma R&D · NCT04717934

This study is testing an injectable treatment called GAL1906 to see if it can safely reduce wrinkles in the chest area without affecting mammogram results.

Quick facts

PhaseNA
Study typeInterventional
Enrollment192 (estimated)
Ages22 Years and up
SexFemale
SponsorGalderma R&D (industry)
Locations14 sites (Birmingham, Alabama and 13 other locations)
Trial IDNCT04717934 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of GAL1906, an injectable treatment, for correcting wrinkles in the décolletage area. It is a randomized, evaluator-blinded, multicenter study that includes a follow-up sub-study to assess the impact of this treatment on mammogram interpretation. Participants will receive GAL1906 and be monitored for both cosmetic outcomes and any potential interference with mammogram results. The study aims to provide insights into the dual aspects of wrinkle correction and breast imaging safety.

Who should consider this trial

Good fit: Ideal candidates are non-pregnant, non-breastfeeding females over the age of 21 who are seeking treatment for wrinkles in the décolletage.

Not a fit: Patients with known allergies to injectable hyaluronic acid or related anesthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safe and effective option for women seeking to improve the appearance of wrinkles in the décolletage area without compromising mammogram accuracy.

How similar studies have performed: While there have been studies on injectable treatments for wrinkles, the specific evaluation of mammogram interpretation following such treatments is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Wrinkle, Wrinkles in the Décolletage Area

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.