Multi Center Evaluation for the Treatment of Cellulite Using A New Minimally Invasive Laser Approach
Cellulite is a topographical alteration of the skin surface believed to be caused by expansion of fat cells, fibrosis of the septae, and dermal skin laxity. A new laser assisted minimally invasive approach using the Nd:YAG 1440nm wavelength laser was developed and studied for the efficacy and safety for treatment of cellulite affecting the structure in the dermal and subcutaneous tissue layers.
Methods/Technique: A total of 57 subjects in 6 clinical sites were treated for unwanted cellulite. Each subject received one laser treatment in the left and right buttocks or thighs. A 3 step approach was incorporated involving 1). Deplaning of fat cells; 2). Thermal subcision of septae; 3). Heating of the superficial layer. A Nd:YAG 1440nm laser was used to apply energy subdermally through a side-firing fiber optic delivery system. A temperature sensing cannula system was used to ensure proper temperature control in the treatment area throughout the procedure. High resolution digital photographs were taken before treatment and at 2, 3 and 6 month follow up visits. Photographs were randomized and evaluated by blinded evaluators. Evaluators selected baseline photos from treated ones and graded each photos on the severity of cellulite classified as dimples and irregularities utilizing a modified Nurnberger–Muller scale. Both physician and subjects completed post treatment satisfaction evaluation at 2 and 3 months. Adverse events were monitored and reviewed.
Results/Complications: The treatment was well tolerated by all subjects. Events including pain, swelling, numbness, itching and purpura were resolved prior to three months. Blinded evaluators reviewing baseline vs. post treatment photographs correctly selected baseline photos in 93% of all study subjects. When grading the improvement in the severity of cellulite, results showed > 90% of subjects had at least 1 score improvement in either dimples or irregularities. The average satisfaction of physicians and subjects were 5.4 and 4.7 respectively based on a 6-point satisfaction scale
Conclusion:
A minimal invasive treatment using a 1440-nm pulsed laser improves the appearance of cellulite with minimal adverse effects.