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

Phase 4

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Macrolane VRF30	Macrolane VRF30	Injection of Macrolane VRF30 in buttocks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12	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.
Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1	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.

Locations (4): Centro Clinico Mir-Mir
🇪🇸
Barcelona, Spain
Akademikliniken
🇸🇪
Stockholm, Sweden
Cirugia Plastica
🇪🇸
Madrid, Spain
Artemedis Center for Plastic Surgery
🇧🇪
Sint-Denijs-Westrem, Belgium