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COMPLETED
NCT04717934
NA

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

Sponsor: Galderma R&D

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2021-02-08

Completion Date

2025-06-13

Last Updated

2026-07-15

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

GAL1906

hyaluronic acid dermal filler gel

Locations (14)

Galderma Research Site

Birmingham, Alabama, United States

Galderma Research Site

Scottsdale, Arizona, United States

Galderma Research Site

Redondo Beach, California, United States

Galderma Research Site

San Diego, California, United States

Galderma Research Site

Vista, California, United States

Galderma Research Site

Westport, Connecticut, United States

Galderma Research Site

Boynton Beach, Florida, United States

Galderma Research Site

Coral Gables, Florida, United States

Galderma Research Site

Alpharetta, Georgia, United States

Galderma Research Site

Chicago, Illinois, United States

Galderma Research Site

Baltimore, Maryland, United States

Galderma Research Site

New York, New York, United States

Galderma Research Site

Spring, Texas, United States

Galderma Research Site

Mequon, Wisconsin, United States