Volume Restoration and Shaping of the Buttocks
Conditions
Brief summary
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
Interventions
DEVICEMacrolane 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
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Belgium, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macrolane VRF30 Injection of Macrolane VRF30 in buttocks
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 | 61 |
| Total | 61 |
Baseline characteristics
| Characteristic | Macrolane VRF30 |
|---|---|
| Age, Continuous | 41.3 years |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 61 |
| serious Total, serious adverse events | 2 / 61 |
Outcome results
Primary
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.
Time frame: 6 Months
Population: Intention to treat, subjects with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane VRF30 | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6 | 80.4 percentage of participants |
Secondary
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.
Time frame: 1 Month
Population: Intention to treat, subjects with available data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane VRF30 | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1 | 91.2 percentage of participants |
Secondary
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.
Time frame: 12 Months
Population: Intention To Treat. Subjects with data available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macrolane VRF30 | Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12 | 68.0 percentage of participants |