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

Study Overview
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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.

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

Conditions
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Volume Restoration and Shaping of the Buttocks

Intervention / Treatment
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* Device: Macrolane VRF30


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macrolane VRF30<br>Injection of Macrolane VRF30 in buttocks | Device: Macrolane VRF30<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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