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

September 26, 2022 updated by: Galderma R&D

An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Sint-Denijs-Westrem, Belgium, 9051
        • Artemedis Center for Plastic Surgery
  • Spain
      • Barcelona, Spain, 08006
        • Centro Clinico Mir-Mir
      • Madrid, Spain, 28046
        • Cirugia Plastica
  • Sweden
      • Stockholm, Sweden, 115 42
        • Akademikliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Macrolane VRF30
Injection of Macrolane VRF30 in buttocks
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
Time Frame: 6 Months

To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS).

Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1
Time Frame: 1 Month

To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS.

Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation.
1 Month
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12
Time Frame: 12 Months

To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS.

Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: Per Hedén, M.D., Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (Estimate)

April 8, 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

  • 31GC0609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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