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 SmoothShapes 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 cm(2) (mean) and increased by 3.82 cm(2) (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.