(Macrolane VR30) in Buttocks Reshaping and contouringCellulite (Macrolane VR30) in Buttocks Reshaping and Contouring

Study Overview
=================
Brief Summary
-----------------
The most common treatments today for enhancing the shape and size of the buttocks are transplantation of the patient's own body fat after liposuction and insertion of permanent implants. Macrolane VRF30 is a gel product based on hyaluronic acid which is a transparent slow-flowing gel. A similar hyaluronic-acid gel from the same manufacturer, Q-Med AB, has been used for many years for the treatment of facial wrinkles. By injecting Macrolane gel into the skin, the shape of the buttocks can be altered and their volume increased.

Detailed Description
-----------------
Aesthetic dermatologists have reported promising results on the use of Macrolane VRF30 for buttocks reshaping and contouring. Although treatment with Macrolane VRF is well documented in breast enhancement, there is limited documentation on the use in buttocks reshaping. Based on these clinical impressions, this study aims at acquiring information on the efficacy and safety of Macrolane VRF30 in this particular indication. As a result of the reshaping of the buttocks, it is expected that improvement of skin laxity will result in contouring and reduction of cellulite. By using standardised evaluation tools, the results of buttock reshaping reported anecdotally can be confirmed by accurate measurements.

Official Title
-----------------
An Open, Non-comparative Single Center Study to Evaluate Efficacy and Safety of HA (Macrolane VR30) in Buttocks Reshaping and Contouring

Conditions
-----------------
Cellulite of the Buttocks

Intervention / Treatment
-----------------
* Device: Hyaluronic acid injection (Macrolane VRF30)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Female subjects older than 30 years. 2. Subjects presenting with loss of contour of the upper half of the buttocks, associated with skin laxity and appearance of cellulite grade 1 or 2 on items A, B and D of the CSS. 3. Treatment-naïve subjects for fillers in the areas to be treated. 4. Subjects with signed informed consent. 5. Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study and use the product under investigation. 6. Subjects should maintain their habits regarding physical activity. 7. Availability of the subject throughout the duration of the study. Exclusion Criteria: 1. Pregnant women or women intending to get pregnant in the next 12 months. 2. Subjects with known hypersensitivity to any compound of the study product or anaesthesia used in the study. 3. Subjects with history of any other adverse effect, which should prevent the subject from participating in the study according to the investigator's opinion. 4. Subjects participating in other clinical trials within 30 days prior to baseline. 5. Any prior surgery, any prior cosmetic procedures or side effects from previous procedures in the buttocks, including permanent fillers, liposuction and prosthesis, that may interfere with the results. 6. Subjects with presence of autoimmune disease or other chronic disease that in the opinion of the Investigator may interfere with the outcome of the study. 7. Subjects on immunomodulatory therapy (suppressive or stimulatory). 8. Subjects with active inflammation or infection in the areas to be treated. 9. Subject with bleeding disorders or subjects who are taking thrombolytics or anticoagulants. 10. Subjects who have taken inhibitors of platelet aggregation, including nonsteroidal anti-inflammatory agents and acetylsalicylic acid, 2 weeks before treatment. 11. Subjects with contraindications for MRI, such as presence of pacemaker, clips or splinter, metal prosthesis or tendency for claustrophobia. 12. Subjects who are study site staff for this study, or close relatives of the study site staff, as well as subjects who are employed by the Sponsor company, or close relatives of employees at the Sponsor company.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macrolane<br>All subjects will receive hyaluronic acid injection (Macrolane VRF30) | Device: Hyaluronic acid injection (Macrolane VRF30)<br>* Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Aesthetic Improvement of the Buttocks Using Investigator GAIS | Assess the aesthetic improvement of the buttocks after reshaping in female subjects with cellulite associated with laxity and loss of volume of the buttocks at each follow up visit after treatment using the investigator Global Aesthetic Improvement Scale (GAIS). | 48 weeks post treatment | 
| Mean Improvement in Cellulite Severity Compared to Baseline Using the Cellulite Severity Scale (CSS) | Assess improvement of cellulite in the buttock areas compared to baseline at each follow up visit after treatment using the Cellulite Severity Scale (CSS). A scale graded 1-15 that measures the severity of cellulites. Grade 1-5 is mild; grade 6-10 is moderate; grade 11-15 is severe. | 48 weeks post treatment | 
| Number of CSS Responders | Assess the CSS responder rate, where a responder is defined as a subject who has improved at least one grade from baseline in items A and/or B and/or D of the CSS. | 48 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Related Adverse Events | Number of subjects with related adverse events | Until 48 weeks post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cellulite