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

Galderma

Status: Completed

Conditions: Wrinkle

Treatments: Device: GAL1906

Study type: Interventional

Funder types: Industry

Identifiers

NCT04717934

43USRV1906

Details and patient eligibility

About

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.

Enrollment: 211 patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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211 participants in 3 patient groups

GAL1906

Experimental group

Description:

Experimental product for correction of wrinkles

Treatment:

Device: GAL1906

Control

No Intervention group

Description:

No treatment control

Sub-Study

No Intervention group

Description:

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