Macrolane for Enhancement of the Shape and Fullness of the Female Breast

Not Applicable

Completed

• Conditions: Breast Enhancement
• Interventions: Device: Macrolane

• Registration Number: NCT01308853
• Lead Sponsor: Galderma R&D

Brief Summary

The study evaluates treatment procedure, efficacy and safety of Macrolane for female breast enhancement.

Detailed Description

This study evaluates the injection technique and treatment outcome by stepwise inclusion and treatment of Macrolane for female breast enhancement.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-02
• Study Completion: 2010-05
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Results First Submitted: 2018-11-13
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-12
• Results First Posted: 2019-07-02
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Female between 25 and 50 years of age with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion Criteria

• Unreasonable expectations
• Any medical condition that may interfere with the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Macrolane	Macrolane	Open label

Primary Outcome Measures

Name	Time	Method
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment	6 weeks	Inclusion was made in steps in group of 4 subjects. The subjects were followed-up with MRI 1-5 days after the injection to document correct injection technique. Before the next group were treated, the Expert Group evaluated the 6-week follow-up results of the previous group. The injection procedure was, if necessary, changed in accordance with specifically pre-defined parameters.

Secondary Outcome Measures

Name	Time	Method
Percentage of Breasts With Improvement as Assessed by the Investigator	6 weeks	Esthetic improvement was evaluated using the Global Esthetic Improvement Scale (GEIS).; The scale has five grades ranging from worse to very much improved. Subjects defined as "at least improved" are assessed as improved, much improved or very much improved.