Clinical Evaluation of the Safety and Efficacy of a 1060 Nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen
In the ever-present quest to attain the ideal body image, new advancements in device technology offer patients, both men and women, more treatment options than ever before to meet their aesthetic expectations for body contouring. Liposuction remains the gold standard for fat removal and improved contour. Despite its proven efficacy, there remains a large number of patients who are surgically averse, preferring non-surgical alternatives. Currently, there are five leading non-invasive body contouring options indicated for lipolysis: cryolipolysis, radiofrequency (RF), high-intensity focused ultrasound (HIFU), low level laser therapy (LLLT) and hyperthermic laser treatment.
The purpose of this study was to evaluate the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the abdomen region.
Methods/Technique
:This multi-center study protocol enrolled 30 male and female subjects between the ages of 25-62. Individuals were asked to refrain from making major changes in their diet or lifestyle during the course of the study. Exclusionary criteria included pregnancy, nursing in the last six months, prior liposuction to the treatment area in past twelve months, immunosuppression, implants in the treatment area, use of medications that induce photosensitivity, skin disorders, tattoos in the treatment area, severe laxity, use of anticoagulants, abdominal hernia, unstable weight within the past 6 months, use of retinoids, and a history of poor scar formation. Each subject received a single study treatment with a 1060 nm diode laser with the power set between 1.2 and 1.4 W/cm2. Baseline photos and ultrasound images were taken and compared to those at 6 and 12 weeks post treatment. Subjects were followed up at 6 and 12 weeks post treatment. Subjects completed a satisfaction questionnaire at the study exit.
Results/Complications
:29 subjects completed one treatment and the necessary 6 and 12-week follow‐up visits to be included in these results. One subject was lost to follow up. Three blinded evaluators could correctly identify the pre‐treatment image compared to the post‐treatment image in an average of 64% of subjects. Subject satisfaction was high, with 70% stating they were satisfied to very satisfied on a five-point Likert Scale. Subject comfort was also high, as the average pain score reported using the Wong Baker, where 0 is no pain and 10 is the worst pain imaginable, was 3.1 out of 10. All but two subjects tolerated the entire treatment at maximum power (1.4 W/cm2); for one subject, the machine was turned off and restarted, and for another subject, the power was temporarily brought down to 1.2 W/cm2. The ultrasound images compared between baseline to 12 weeks showed an average reduction in the abdominal adipose layer of 8.2%. 72% of subjects would recommend this treatment to a friend.
Conclusion
:The results from this study highlight the safety and efficacy of a single treatment using a 1060nm (±10nm) diode laser to improve the appearance of unwanted fat in the abdomen. Quantitative ultrasound data demonstrated a significant reduction in adipose layer thickness of the abdomen at the 12-week follow up visit (8.2%). Additionally, treatment was associated with high satisfaction, with the majority of subjects reporting they were “satisfied” or “very satisfied” with their results. The treatment was well tolerated among all subjects, with only minimal discomfort reported. Though the majority of subjects experienced trace to moderate erythema and edema immediately post-treatment, these events are considered anticipated clinical responses and were only transient in nature. There were no long-term side effects or reports of adverse events during the study duration, providing further evidence to support the device’s safety in the indicated population. With the non-invasive device market continuing to expand and advance, the results of this study confirm the safe and effective application of the 1060nm (±10nm) diode laser for the improvement of unwanted fat in the abdomen and flanks. Future studies are evaluating the efficacy of multiple treatments in a single region.