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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

NCT04717934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2025-08-17

No results posted yet for this 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.

Conditions

  • Wrinkle

Interventions

DEVICE

GAL1906

hyaluronic acid dermal filler gel

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2025-05-26
Completion
2025-06-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04717934 on ClinicalTrials.gov