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: 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.

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Key information

Conditions

Wrinkle

Age range

22 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Research Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GAL1906

Device

hyaluronic acid dermal filler gel

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jan 22, 2021
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed