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: 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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04717934

Enrollment

211

Registered

2021-01-22

Start date

2021-02-08

Completion date

2025-06-13

Last updated

2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrinkle

Keywords

Wrinkles in the Décolletage Area

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.

Interventions

DEVICEGAL1906

hyaluronic acid dermal filler gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

22 Years to No maximum

Healthy volunteers

Yes

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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026