A Study of a Novel Controlled Focal Septa Release Method for Improving Cellulite

Abstract

Background: Cellulite is a common and often emotionally distressing condition among affected individuals. The dimpled appearance is caused by fibrous connective tissue, or septa, which tether the dermis to underlying fascia. A novel, minimally invasive, controlled focal septa release method was developed to selectively identify, target and manually release the tethers in a precise manner from a single insertion point (Revelle Aesthetics). The following pilot study evaluated the safety and feasibility of this method for treating subjects with moderate-to-severe cellulite. Methods: Female subjects (N = 10), 21–55 years old underwent unilateral controlled, focal fibrous septa release on the buttocks and thighs. Local anesthesia was administered using standard techniques. Cellulite depressions were marked with the subject standing at rest. Target septa were identified in the marked areas by applying tension with the device to reproduce the dimple appearance on the skin. Once identified, the contributing septa were severed with the device. For eight subjects, access was achieved with one small incision in the gluteal crease. Study assessments occurred on posttreatment days 1, 3, 14, 30, and 90. Results: All procedures were successfully completed with no serious or unexpected adverse events and the procedure was well tolerated. Mild adverse events were transient bruising and soreness. Target septa can be visualized on the skin by applying tension with the device. Multiple depressions can be treated from a single entry point. Conclusion: These results confirm the safety and feasibility of the controlled focal fibrous septa release method to treat moderate and severe cellulite. Additional trials are ongoing.