Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Enhancement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Macrolane VRF30

Group Type EXPERIMENTAL

Macrolane VRF30

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE