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NCT04717934 Clinical Trial

A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area

Wrinkle Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04717934
Other study ID # 43USRV1906
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date September 20, 2023

Study information
Verified date December 2023
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.

Recruitment information / eligibility
Status Completed
Enrollment 192
Est. completion date September 20, 2023
Est. primary completion date November 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years and older
Eligibility 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. 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GAL1906
hyaluronic acid dermal filler gel

Locations
Country Name City State
United States Galderma Research Site Alpharetta Georgia
United States Galderma Research Site Baltimore Maryland
United States Galderma Research Site Birmingham Alabama
United States Galderma Research Site Boynton Beach Florida
United States Galderma Research Site Chicago Illinois
United States Galderma Research Site Coral Gables Florida
United States Galderma Research Site Mequon Wisconsin
United States Galderma Research Site New York New York
United States Galderma Research Site Redondo Beach California
United States Galderma Research Site San Diego California
United States Galderma Research Site Scottsdale Arizona
United States Galderma Research Site Spring Texas
United States Galderma Research Site Vista California
United States Galderma Research Site Westport Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12. Responder defined as at least one grade improvement from baseline 12 weeks after initial injection
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