Effect of 635nm Low-level Laser Therapy on Upper Arm Circumference Reduction

Objective: To assess the safety and efficacy of low-level laser therapy as a noninvasive method for reducing upper arm circumference. Design: Randomized, double-blind study whereby healthy subjects (N=40) with a body mass index of 20 to 35kg/m received three 20-minute low-level laser therapy (N=20) or sham treatments (N=20) each week for two weeks. Measurements: Upper arm circumference was measured after three and six treatments and two weeks post-treatment. Primary success criterion was the proportion of subjects achieving a combined reduction in arm circumference of ≥1.25cm measured at three equally spaced points between the elbow and the shoulder. Secondary outcomes included total measurement change at each time point and subjective satisfaction ratings. Results: After six treatments, the low-level laser therapy group showed a combined reduction in arm circumference of 3.7cm versus 0.2cm in the sham treatment group (p<0.0001). Significantly more subjects in the low-level laser therapy group (N=12; 60%) achieved ≥1.5cm total decrease in upper arm circumference versus sham-treated subjects (N=0; 0%) (p<0.0005). Low-level laser therapy treatment resulted in a combined reduction in arm circumference of 2.2cm after three treatments and 3.7cm after six treatments (for each, p<0.0001) indicating a progressive and cumulative treatment effect. Body mass index remained unchanged for all subjects. A significantly greater number of subjects in the low-level laser therapy treatment group were satisfied with their results (p<0.05), believed their upper arm appearance improved (p<0.0005), and indicated the results exceeded expectations (p<0.05). The treatments were painless and no adverse events were reported. Conclusion: Noninvasive low-level laser therapy is safe, painless, and effective in reducing upper arm circumference and is associated with a high degree of subject satisfaction. (J Clin Aesthet Dermatol. 2012;5(2):42–48.) DISCLOSURE: This study was sponsored by a research grant from Erchonia Corporation, McKinney, Texas. Dr. Nestor has received honoraria as a speaker for Erchonia Corporation as well as from Zeltiq Aesthetics, Inc., and Human Med Inc. Drs. Zarraga and Park report no relevant conflicts of interest. ADDRESS CORRESPONDENCE TO: Mark S. Nestor, MD, PhD, Center for Clinical and Cosmetic Research, 2925 Aventura Boulevard, Suite 205, Aventura, FL 33180; E-mail: [email protected] Effect of 635nm Low-level Laser Therapy on Upper Arm Circumference Reduction A Double-blind, Randomized, Sham-controlled Trial MARK S. NESTOR, MD, PhD; MATTHEW B. ZARRAGA, DO; HYUNHEE PARK, DO Director of the Center for Clinical and Cosmetic Research, Center for Cosmetic Enhancement, Aventura, Florida; Department of Dermatology and Cutaneous Surgery, University of Miami, Miller School of Medicine, Miami, Florida; Dermatology Fellow, Center for Clinical and Cosmetic Research, Aventura, Florida N oninvasive body contouring is one of the fastest growing segments of the cosmetic aesthetic industry. Surgical options carry disadvantages, such as the use of anesthetics, pain, swelling, and long recovery, and there is an increasing public demand for procedures with fewer side effects and shorter recovery times. Many new noninvasive body contouring technologies have been developed including suction-massage, radiofrequency energy, high-frequency focused ultrasound, cryolipolysis, and low-level laser therapy (LLLT). LLLT has been shown to be an efficacious adjunct therapy for numerous cosmetic procedures, including breast augmentation and lipoplasty. With regard to body contouring, a randomized, double-blind, sham-controlled study using a 635nm LLLT device (Zerona, Erchonia Corporation, McKinney, Texas) showed circumferential reduction of the waist, hips, and thighs following six treatments administered over a two-week period. This device has been shown to provide other significant clinical benefits including reduction in cholesterol and leptin levels