A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.

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Detailed Description

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Conditions

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Volume Restoration and Shaping of the Buttocks

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Macrolane VRF30

Injection of Macrolane VRF30 in buttocks

Group Type EXPERIMENTAL

Macrolane VRF30

Intervention Type DEVICE

Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject

Interventions

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Macrolane VRF30

Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ≥ 20 years old
* willing to undergo augmentation therapy of the buttocks where a maximum total injected volume of 400 ml of the study product is judged by the Investigator to be enough to achieve full correction
* understand and comply with the requirements of the study
* be willing to understand and comply with the requirements of the study
* be willing to abstain from esthetic surgery and esthetical augmentation procedures (other than the study treatment) between the umbilicus and the knees.
* be a male or non-pregnant, non breast-feeding female.
* give written informed consent to participate in the study

Exclusion Criteria

* Active skin disease, inflammation or related conditions Tumors or pre-malign tissue disorder near or on the area to be treated
* scar tissue in the area to be treated
* subjects seeking corrections for other body parts then the buttocks anywhere between the umbilicus and the knees
* subjects with human immunodeficiency virus (HIV) associated lipodystrophy
* subjects having undergone liposuction within 6 months prior to inclusion
* BMI \<20 or expected instable weight
* insufficient tissue cover in the area to be treated
* excessive skin laxity in the area to be treated
* other injectable implant or permanent implant near or in the area to be treated
* previous radiation therapy of tumors near or in the area to be treated
* concomitant anticoagulant therapy, anti-platelet therapy or a history of bleeding disorders.
* a presence or history of connective tissue diseases
* ongoing immunosuppressive therapy
* known allergies or hypersensitivity reactions towards anesthetics
* previous inflammatory or hypersensitivity reactions towards products containing Hyaluronic acid
* any condition which in the opinion of the investigator makes the subject unsuitable for inclusion use of any investigational drugs or devices within 30 days prior to inclusion.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes