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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cellulite of the Buttocks

Interventions

Type	Name	Description
DEVICE	Hyaluronic acid injection (Macrolane VRF30)	Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-05-01
• Last updated: 2022-08-26
• Results posted: 2020-10-22

Locations

1 site across 1 country: Brazil