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

Last updated: February 11, 2025
Sponsor: Galderma R&D
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

GAL1906

Clinical Study ID

NCT04717934
43USRV1906
  • Ages > 22
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 192
Treatment Group(s): 1
Primary Treatment: GAL1906
Phase:
Study Start date:
February 11, 2025
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Galderma Research Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Galderma Research Site

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Galderma Research Site

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Galderma Research Site

    San Diego, California 92121
    United States

    Site Not Available

  • Galderma Research Site

    Vista, California 92083
    United States

    Completed

  • Galderma Research Site

    Westport, Connecticut 06880
    United States

    Site Not Available

  • Galderma Research Site

    Boynton Beach, Florida 33472
    United States

    Active - Recruiting

  • Galderma Research Site

    Coral Gables, Florida 33146
    United States

    Completed

  • Galderma Research Site

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Galderma Research Site

    Chicago, Illinois 60654
    United States

    Site Not Available

  • Galderma Research Site

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Galderma Research Site

    New York, New York 10021
    United States

    Completed

  • Galderma Research Site

    Spring, Texas 77388
    United States

    Site Not Available

  • Galderma Research Site

    Mequon, Wisconsin 53092
    United States

    Site Not Available

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