Volume Restoration and Shaping of the Buttocks Clinical Trial
Official title:
An Open, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
| NCT number | NCT01331408 |
| Other study ID # | 31GC0609 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | September 2008 |
| Est. completion date | May 2011 |
| Verified date | June 2019 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate the efficacy and safety of Macrolane for volume restoration and shaping of the buttocks.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | May 2011 |
| Est. primary completion date | October 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Artemedis Center for Plastic Surgery | Sint-Denijs-Westrem | |
| Spain | Centro Clinico Mir-Mir | Barcelona | |
| Spain | Cirugia Plastica | Madrid | |
| Sweden | Akademikliniken | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
Belgium, Spain, Sweden,
Camenisch CC, Tengvar M, Hedén P. Macrolane for volume restoration and contouring of the buttocks: magnetic resonance imaging study on localization and degradation. Plast Reconstr Surg. 2013 Oct;132(4):522e-529e. doi: 10.1097/PRS.0b013e31829fe47e. — View Citation
De Meyere B, Mir-Mir S, Peñas J, Camenisch CC, Hedén P. Stabilized hyaluronic acid gel for volume restoration and contouring of the buttocks: 24-month efficacy and safety. Aesthetic Plast Surg. 2014 Apr;38(2):404-12. doi: 10.1007/s00266-013-0251-9. Epub 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
6 Months | |
| 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. |
1 Month | |
| 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. |
12 Months |