NCT01299532

Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

Conditions

• Breast Enhancement

Interventions

Type	Name	Description
DEVICE	Macrolane VRF30	Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-06-01
• Completion: 2013-10-01
• First posted: 2011-02-18
• Last updated: 2022-09-28

Locations

5 sites across 2 countries: France, Sweden