- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127723
(Macrolane VR30) in Buttocks Reshaping and contouringCellulite (Macrolane VR30) in Buttocks Reshaping and Contouring
An Open, Non-comparative Single Center Study to Evaluate Efficacy and Safety of HA (Macrolane VR30) in Buttocks Reshaping and Contouring
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90570-040
- Dr Hexsel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Macrolane
All subjects will receive hyaluronic acid injection (Macrolane VRF30)
|
Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
|
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
Time Frame: 48 weeks post treatment
|
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)
Time Frame: 48 weeks post treatment
|
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
Time Frame: 48 weeks post treatment
|
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
Time Frame: Until 48 weeks post treatment
|
Number of subjects with related adverse events
|
Until 48 weeks post treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doris Hexsel, Dr, Brazilian Center For Studies in Dermatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31GC1202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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