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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
Dr Hexsel
Porto Alegre, Rio Grande do Sul, Brazil
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).
Time frame: 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.
Time frame: 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.
Time frame: 48 weeks post treatment
Number of Subjects With Related Adverse Events
Number of subjects with related adverse events
Time frame: Until 48 weeks post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.