NCT04717934

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 22 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	GAL1906	hyaluronic acid dermal filler gel

Timeline

• Start date: 2025-02-11
• Primary completion: 2025-05-26
• Completion: 2025-06-13
• First posted: 2021-01-22
• Last updated: 2025-08-17

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study