Abstract
Background: This study compares the efficacy and safety of low‐level, dual‐wavelength laser energy and massage with massage alone for the reduction of subcutaneous fat in the thighs of normal women. The device was an early prototype of the FDA‐cleared SmoothShapesTM system (Elemé Medical, Merrimack, NH, USA). Methods: The thighs of each individual (n = 102) were randomized to either laser light (dual wavelength of 650±20 nm and 915±10 nm) and massage or to massage alone (control). Individuals who completed the study (n = 74) received a mean of 14.3 treatments over 4–6 weeks. Magnetic resonance imaging (MRI) scans quantified fat pad dimensions before and after the final treatment. Results: Fat thickness decreased for the leg treated with laser‐massage by 1.19 cm2 (mean) and increased by 3.82 cm2 (mean) for the control leg over time. The difference was statistically significant (p<0.001). Among those who completed the study, 82.26% responded to treatment. Individuals reported looser‐fitting clothing and satisfaction with the procedure and results. Adverse effects were limited to occasional increases in urinary frequency. Conclusion: Low‐level, dual‐beam laser energy with massage appears to be safe and more efficacious than massage alone for reducing subcutaneous fat in the thighs of normal women.