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

Breast Enhancement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308853
• Other study ID #: 31GB0607
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: May 2010

Study information

• Verified date: June 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Enhancement

Intervention

Device:
• Macrolane
Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

References & Publications (1)

Hedén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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