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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-11

Study Completion Date

2025-06-13

Brief Summary

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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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Detailed Description

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Conditions

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Wrinkle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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GAL1906

Experimental product for correction of wrinkles

Group Type EXPERIMENTAL

GAL1906

Intervention Type DEVICE

hyaluronic acid dermal filler gel

Control

No treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

Sub-Study

FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GAL1906

hyaluronic acid dermal filler gel

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 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

* 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 is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.

Minimum Eligible Age

22 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes