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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Enhancement
• Intervention / Treatment: Device: Macrolane

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Macrolane; Open label	Device: Macrolane; Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Breasts With Improvement as Assessed by the Investigator	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.	6 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Per Hedén, M.D., Akademikliniken, Stockholm, Sweden

Publications and helpful links

General Publications

• Heden P, Olenius M, Tengvar M. Macrolane for breast enhancement: 12-month follow-up. Plast Reconstr Surg. 2011 Feb;127(2):850-860. doi: 10.1097/PRS.0b013e318200ae57.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 22, 2011
• First Submitted That Met QC Criteria: March 3, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 31GB0607