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

Launched by GALDERMA R&D · Jan 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called GAL1906, which is designed to help reduce wrinkles in the décolletage area, which is the skin on the chest and neck. The main part of the study will compare how safe and effective this treatment is for women who want to improve the appearance of their skin. There is also a follow-up study that will check if the hyaluronic acid injections used in GAL1906 affect the results of mammograms, which are important for breast health screening.

To be eligible for this trial, women must be over 21 years old, not pregnant or breastfeeding, and interested in treating wrinkles in their décolletage area. Participants will need to provide written consent to be part of the study. They can expect to receive either the treatment or no treatment at all, and their progress will be monitored by medical professionals. It's important to know that women with certain allergies or who are currently pregnant or nursing will not be able to participate in this trial.

Gender

FEMALE

Eligibility 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.