PHOENIX - A dual-wavelength laser system with mechanical manipulation effectively reduced thigh circumference in a multicenter, 83-patient study.

The SmoothShapes system (Elemé Medical Inc.) combines a 915-nm laser with a 650-nm LED light, which is believed to stimulate collagen regeneration and to improve and restore blood and lymphatic circulation.

The system is cleared by the Food and Drug Administration for the temporary reduction in the appearance of cellulite and features contoured rollers that massage tissue and move interstitial fluid toward the lymphatic system. A vacuum enables consistent light penetration to tissue.

At the annual meeting of the American Society for Laser Medicine and Surgery, Dr. Robert A. Weiss, director of the Maryland Laser, Skin, and Vein Institute in Hunt Valley, Md., presented results from a single-blinded clinical study in which he and his associates randomly assigned women to have one thigh treated using the SmoothShapes system. The other thigh served as the control.

Each patient had circumferential measurements of the upper, mid, and lower thigh taken pre-treatment, after 4 treatments, immediately after 8 treatments, and at 1 month follow-up after completion of treatments.

Location for the measurements was determined with a laser-based device and recorded for accuracy and reproducibility. Treatment consisted of 8 twice weekly, 30-minute treatments of the entire thigh.

Dr. Weiss, also of the department of dermatology at Johns Hopkins University in Baltimore, reported results from 83 patients treated at one of six centers. All subjects completed at least 1 month of follow-up and had no data points missing throughout the study.

The mean differences in circumferential measures on the treated and untreated thighs were consistently statistically significant at all three thigh locations (upper, mid, and lower) and at all 3 time points (after 4 treatments, immediately after 8 treatments, and at 1 month after the last treatment).

The average overall reduction among all three thigh areas treated at 1 month follow-up was 1.9 cm; the minimum loss was 0.2 cm; and the maximum loss was 8.7 cm. "We generally saw the greatest results in the upper thigh," Dr. Weiss said.

Preliminary results were similar for 47 patients who completed 3 months of follow-up, Dr. Weiss said. The average overall loss in circumference for all three thigh areas was 1.0 cm; the minimum loss was 0.1 cm; and the maximum loss was 8.7 cm.

He concluded that the SmoothShapes system "was highly effective in producing thigh circumferential reduction at each thigh location and at each evaluation time-point in the study with 1- and 3-month follow-up."

Dr. Weiss disclosed that he received equipment and consulting fees from Elemé Medical Inc. as part of the study.