Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring.

BACKGROUND: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer. OBJECTIVE: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen. METHODS: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination. Electromagnetic muscle stimulation treatments were delivered in 4 sessions over 2 weeks. Cryolipolysis treatments were delivered in one session. Combination treatments consisted of one cryolipolysis and 4 EMMS visits. Efficacy was assessed by independent physician Global Aesthetic Improvement Scale (GAIS), circumferential measurement, Subject GAIS (SGAIS), and Body Satisfaction Questionnaire (BSQ). RESULTS: Safety was demonstrated for all study cohorts with no device- or procedure-related adverse events. Independent photo review showed greatest mean GAIS score for the Cryolipolysis + EMMS cohort followed by Cryolipolysis only, then EMMS only cohort. BSQ showed greatest average score increase for Cryolipolysis + EMMS cohort followed by Cryolipolysis only cohort, then EMMS only cohort. Mean circumferential reduction measurements were greatest for Cryolipolysis + EMMS cohort followed by Cryolipolysis only, and then EMMS only cohort. The mean SGAIS improvement score was equal for the Cryolipolysis only and Cryolipolysis + EMMS cohorts, followed by the EMMS only cohort. CONCLUSION: A multimodal approach using cryolipolysis and EMMS was safe and demonstrated enhanced body contouring efficacy for this feasibility study.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Seborrheic Keratoses.

BACKGROUND: Nanosecond pulsed electric field technology (also known as Nano-Pulse Stimulation or NPS) is a nonthermal, drug-free, energy-based technology that has demonstrated effects on cellular structures of the dermis and epidermis in previous clinical studies. OBJECTIVE: To evaluate the safety and efficacy of a single NPS treatment for clearing seborrheic keratoses (SKs). MATERIALS AND METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. Fifty-eight subjects had 3 of 4 confirmed SK lesions treated, resulting in 174 total treated lesions. Subjects returned for 5 to 6 follow-up evaluations and photographs. RESULTS: At 106 days after NPS treatment, 82% of treated seborrheic keratoses were rated clear or mostly clear by the assessing physician. Seventy-one percent of lesions were rated clear or mostly clear by the 3 independent reviewers based on the 106-day photographs. All treated subjects returned for all study visits, and 78% of the subjects were satisfied or mostly satisfied with the outcome of the treatment. No adverse events were reported. CONCLUSION: The NPS procedure was well tolerated and effective in the removal of SKs.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.

BACKGROUND: Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. OBJECTIVE: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. RESULTS: At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. CONCLUSION: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612570.

Efficacy of a multiple diode laser system for body contouring.

BACKGROUND AND OBJECTIVES: Low-level laser therapy (LLLT) has been shown to induce cellular reactions in nonphotosynthetic cells however skepticism remains regarding efficacy at the clinical level. The purpose of this study was to evaluate the efficacy of LLLT independent of liposuction. Additionally, a weight loss supplement (Curva™, Santa Barbra Medical Innovations, Santa Barbra, CA) was evaluated. This clinical trial evaluates the effectiveness of the Erchonia EML Laser (Zerona™ System, Santa Barbra Medical Innovations) for non-invasive fat reduction and body contouring in a split-body clinical evaluation. MATERIALS AND METHODS: Five subjects were enrolled and completed the study. Subjects had a body mass index (BMI) of less than or equal to 29 kg/m(2) and satisfied the set inclusion criteria. Participants were randomly assigned to receive low-level laser treatments on one side of the body three times per week for 2 weeks. One group took the weight loss supplement and was also treated with the laser. Subject satisfaction questionnaires, physician blinded photo evaluation, circumference measurements and ultrasound measurements were utilized to evaluate efficacy. RESULTS: Circumference measurements revealed no statistically significant reduction at either 7 days or 1 month post-treatment. One month following treatment the greatest circumference reduction overall was 0.5 ± 0.3 inches. Ultrasound measurements also did not reveal statistically significant reduction in fat layer thickness (P > 0.5). Evaluation by three blinded dermatologists resulted in average correct photo identification of 51.1%. Results reflect little clinical difference between post-treatment and baseline images. Three subjects recording a "dissatisfied" rating on satisfaction questionnaires and all subjects reported the effects of the treatment were less than expected. Subjects who took the weight loss supplement had no greater circumference reduction or identifiable clinical outcome. CONCLUSIONS: This small study demonstrates to the authors that there needs to be more evidence to show clinical circumferential reduction before LLLT can be recommended as an effective therapeutic option.

Clinical study to determine the safety and efficacy of a low-energy, pulsed light device for home use hair removal.

BACKGROUND AND OBJECTIVES: The principle of selective photo-thermolysis has been studied extensively for hair removal applications in a medical setting. A new, portable, hand-held device featuring two filtered Xenon lamps that utilizes pulsed light in low optical fluencies for hair removal has been developed for consumer use. The purpose of this clinical study was to determine the efficacy and safety of this low-energy, pulsed-intense light device intended for home use hair removal. STUDY DESIGN/ MATERIALS AND METHODS: The treatment group consisted of 10 adults with skin types I-IV who possessed unwanted dark hair in the non-facial region. The subjects received between 4 and 6 treatments on a bi-weekly basis with the device by a trained member of the clinical staff. The clinical responses were evaluated by performing manual hair counts using magnified vision and photographs which were obtained prior to treatment and at each subsequent visit. RESULTS: Mean hair reduction was 36% 4 weeks after the final treatment and 10% 12 weeks after the final treatment. This resulted in a mean hair count reduction of 23% over the two follow-up appointments. There was no definitive correlation between customer satisfaction and hair count reduction. Adverse reactions were limited to transient, localized, post-treatment erythema. No complications were encountered. CONCLUSIONS: This low-energy, pulsed-light device is a quick, safe, and relatively effective at-home hair reduction treatment option in patients with various skin phototypes.

Complications of laser dermatologic surgery.

BACKGROUND AND OBJECTIVE: Innovations in lasers, light and radiofrequency devices have allowed for improved therapeutic efficacy and safety and the ability to treat patients with an ever-increasing number of medical and aesthetic indications. Safety remains a primary concern and the timely communication of complications and their management is vital to insure that treatments be as safe as possible. The purpose of this report on the Proceedings of the First International Laser Surgery Morbidity Meeting is to provide laser experts the opportunity to present and discuss complications that their patients have experienced and how they were successfully managed. METHODS: Laser experts were invited to present complications of laser, light, and radiofrequency treatments that their patients have experienced and to discuss the potential mechanisms leading to the complications their management and final outcomes. RESULTS: Nineteen unique cases are presented and the clinical management of each case discussed. Eighteen sets of pre- and post-operative photos are presented. CONCLUSION: This report shows that even experts, with extensive experience using light-based therapies, can and do have patients who develop complications. Sound clinical judgment, and knowing how to avoid complications and their timely post-operative management, is essential to insure optimal therapeutic outcome.

Confocal microscopy study of nerves and blood vessels in untreated and treated port wine stains: preliminary observations.

BACKGROUND AND OBJECTIVE: Vascular ectasia in port wine stain birthmarks (PWS) might result from reduced innervation with loss of autonomic stimulation. We investigated this theory and evaluated nerve and blood vessel density, and mean blood vessel size in untreated and treated PWS skin. METHODS: Skin biopsy specimens were obtained from uninvolved skin, untreated PWS, PWS with a good response to laser treatment and PWS with a poor response to laser treatment. Confocal microscopy was performed to determine nerve and blood vessel density, and mean blood vessel size. RESULTS: Nerve density was significantly decreased in all PWS sites compared to uninvolved skin. Mean blood vessel diameter was larger in untreated compared to treated PWS. PWS with a good response to treatment had decreased nerve density but blood vessel density and mean diameter was relatively normal. PWS with a poor response to treatment had decreased nerve density but increased blood vessel density and mean blood vessel diameter compared to normal skin. CONCLUSION: Nerve density was decreased in all evaluated PWS sites and this may be a factor in lesion pathogenesis. PWS blood vessel size correlated with pulsed dye laser response and may prove to be a useful prognostic indicator of therapeutic outcome.

Biophysics of nonablative dermal remodeling.

This article explores the physics of nonablative skin remodeling as well as the histologic sequelae. Although there have been several studies of nonablative skin remodeling, the exact mechanisms of action and thus the optimum device-specific parameters are not yet known. The article is divided into a discussion of the physics of laser-tissue interactions, followed by a review of the types of devices used for nonablative skin remodeling, and the histologic findings that follow treatment.