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OpenTrials
Completed

NCT Number: NCT01308853

Macrolane 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.

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Key information

Conditions

Breast Enhancement

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macrolane

Device

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

Primary outcomes

  1. Number of Breasts With Successful Placement of the Implant Posterior to the Mammary Gland at 6 Weeks After Treatment

    Time frame: 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 outcomes

  1. Percentage of Breasts With Improvement as Assessed by the Investigator

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Mar 4, 2011
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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