Clinical trial NCT01331408: A Study to Evaluate Efficacy and Safety of Macrolane VRF30 for Volume Restoration and Contouring of the Buttocks
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Volume Restoration and Shaping of the Buttocks
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1
timeFrame: 1 Month
measure: Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12
timeFrame: 12 Months
Other outcomes:
Locations:
city: Sint-Denijs-Westrem
country: Belgium
facility: Artemedis Center for Plastic Surgery
city: Barcelona
country: Spain
facility: Centro Clinico Mir-Mir
city: Madrid
country: Spain
facility: Cirugia Plastica
city: Stockholm
country: Sweden
facility: Akademikliniken
Study officials:
affiliation: Akademikliniken, Storängsvägen 10, 115 42 Stockholm, Sweden
name: Per Hedén, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camenisch CC, Tengvar M, Heden 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.
citation: De Meyere B, Mir-Mir S, Penas J, Camenisch CC, Heden 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 2014 Jan 24.