ObjectiveTo examine the efficacy and safety of a new fractional, ablative erbium:glass fiber (Er:glass) laser (2910 nm) at improving clinical signs of photodamaged skin. Materials and MethodsThirty-seven healthy participants aged 38-75 years with photodamaged skin were enrolled into two treatment groups. Group A (n = 14) received up to four laser treatments with mild settings, and focal facial subunits were treated with deeper settings. Group B (n = 23) received a single treatment using deeper settings. Following treatment, pain scores and severity and duration of skin responses (erythema, edema, and pinpoint bleeding) were assessed. Primary outcome was the improvement in participant and investigator Global Aesthetic Improvement Scale (GAIS) at 3-month follow-up. Secondary outcomes were participant satisfaction with treatment and whether they would repeat treatment. ResultsThirty-five participants completed the study (n = 1 lost to follow up in each group). Both groups had similar mean participant and investigator GAIS scores of 3/5 corresponding to "Improvement." All but two patients (both from Group A) reported improvement, satisfaction with treatment, and would repeat treatment. Posttreatment skin responses were mild-to-moderate, lasting up to 5 days. There was no scarring or dyspigmentation. ConclusionThe 2910 nm Er:glass laser provided improvement in photoaging with high patient satisfaction.

Background and Objectives Nano-pulse stimulation (NPS) therapy is the application of ultrafast pulses of high amplitude electrical energy to tissues to influence cell function. Unique characteristics of these pulses enable electric field penetration into the interior of cells and organelles to generate transient nanopores in both organelle and plasma membranes. The purpose of this study is to document the temporal and physical changes in intracellular organelles following NPS therapy using electron microscopy. Study Design/Materials and Methods Liver tumors were induced in five buffalo rats by implanting syngeneic McA-RH7777 hepatocellular carcinoma cells into the surgically exposed livers. Tumors were allowed to grow for 1 week and then the surgically exposed livers were treated in situ with NPS energy delivered at a sufficient level to trigger regulated cell death in the tumor. Samples of NPS-treated and control tissue were removed and fixed for electron microscopy at 1 minute, 5 minutes, 30 minutes, 2 hours and 4 hours after exposure. Results Measurements of cellular organelles indicate strong swelling following NPS therapy exposure compared with untreated controls. The mean diameter of the mitochondria increased by 55% within 1 minute and then by 2.5-fold by 2 hours post-NPS therapy. The rough endoplasmic reticulum (RER) cisternae swelled immediately after NPS therapy with reduced swelling by 30 minutes and loss of structural integrity by 2 hours. The Golgi apparatus appears swollen in images collected 1 and 5 minutes after NPS therapy and was no longer detected at 30 minutes and 2 hours post-NPS therapy. By 4 hours after NPS therapy, a nascent Golgi apparatus was detected in many of the images. The plasma membrane lost its well-defined morphology and became less linear, exhibiting discontinuities as early as 1 minute post-NPS energy exposure and the nuclear envelope became subjectively less distinct over time. Conclusions NPS therapy at sufficient energy levels causes the rapid swelling of organelles, disintegration of the RER, breaks in the plasma membrane and blurs the borders of the nuclear envelope. These changes in the mitochondria and RER are indicative of a regulated cell death process. These immediate physical changes to vital cell organelles are likely to trigger subsequent regulated cell death mechanisms observed in other studies of NPS therapy. Lasers Surg. Med. (c) 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.

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.

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.

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.

BACKGROUND Removing unwanted body hair is a growing trend in society today, and there are many laser-based devices for hair reduction. There are some limitations to those methods, including the lack of efficacy for lighter color hair. OBJECTIVE The objective was to quantify hair reduction in the axillae after treatment with a noninvasive microwave energy device. MATERIALS AND METHODS A prospective, multicenter study was performed at 3 private dermatology clinics. Fifty-six adult subjects seeking axillary hair reduction were enrolled and treated with the device in 1 or 2 treatment sessions 3 months apart at various energy levels, and followed for 12 months. The primary analysis was monitoring reduction of hair counts from baseline to follow-up visits. A subject assessment of overall satisfaction, odor ratings, and sweat reduction ratings was provided at follow-up visits. RESULTS Fifty-six subjects received treatment, with an average total underarm hair reduction of approximately 70% for both light and dark hair. Percentage of patients with hair reduction of 30% or more was significantly higher than 50% at all follow-up visits. Half of treated subjects reported expected mild transient post-treatment effects such as localized edema, discomfort, and bruising. Other reported events were mild. CONCLUSION This clinical study provides evidence for safe and permanent axillary hair reduction, showing stable average reduction that lasted through the year of follow-up. Most notably, the study has shown the treatment's efficacy for reduction of light-colored axillary hair.

BACKGROUND: Fractional ablative lasers have been shown to be safe and effective for improving wrinkles, scars, skin texture, and dyspigmentation. However, the exact effects of this technology in vivo on epidermal and dermal skin constituents have not been delineated. This study evaluated the in vivo histological effects over time of treatment with a fractional ablative CO2 system, using different treatment parameters. MATERIALS AND METHODS Healthy adult volunteers were enrolled in this multicenter clinical study. Study participants, previously scheduled for abdominoplasty, received fractional CO2 laser treatment on the abdomen at a predetermined time prior to surgery. Biopsies were taken at baseline and after CO2 treatment. Morphological and morphometric analyses were performed in the ablated and coagulated tissue areas. RESULTS Nine healthy adult volunteers were treated. Histologic evaluation showed 800-900 micron diameter zones of ablation and coagulation confined to the upper most layer of the skin in the mode with the greatest fractional skin coverage using Light Mode 30 - 50% (spot diameter of 150 microns, 30-60 millijoules fluence), while ablation to levels of up to 900 microns in depth using the Deep Mode (spot diameter 150 microns, 50-80 millijoules). Healing times of treated tissue varied from 1-day post-treatment with the Light Mode, and up to 10 days post-treatment with the Deep Mode. No remnants of ablation or coagulation were seen after 30 days post CO2 treatment with either mode. There were no adverse events associated with treatments. CONCLUSION Treatment of the skin using the fractional CO2 device leads to skin resurfacing via ablation and coagulation of the treated area at a depth proportional to the delivered energy. The higher the energy used, the greater the degree of ablation and coagulation in tissue, which can lead to a greater tissue response in terms of fibroblast activity, collagen remodeling, and new collagen formation. J Drugs Dermatol. 2017;16(11):1085-1090..

BACKGROUNDA novel device using micro-focused ultrasound with high-resolution ultrasound visualization (MFU-V) produces non-invasive lifting and tightening of lax skin on the face and neck when treatment is delivered at a single focal depth (Ulthera® System; Ulthera, Inc., Mesa, AZ).OBJECTIVEThe following study was performed to test the hypothesis that customized application of MFU-V at two focal depths will produce clinical results that are superior to treatment at a single focal depth.METHODS AND MATERIALSAdult subjects (N=71) with skin laxity in the lower face and neck were enrolled; 64 met all entrance criteria and received treatment. On the basis of physical and anatomical characteristics, patients were assigned in nonrandomized fashion to one of three treatment groups to undergo treatment on the submental, submandibular, lower neck, and platysmal areas with MFU-V at single or dual depths.RESULTSAmong evaluable subjects (N=64), investigator-assessment and subject-self-assessment demonstrated improved aesthetic changes at 60, 90, and 180 days after treatment. Overall, subjects that received MFU-V at two focal depths to the entire treatment area achieved slightly greater aesthetic improvement than subjects receiving MFU-V at single focal depths. There were no unexpected adverse events.CONCLUSIONApplying treatment with MFU-V at two focal depths may provide improved aesthetic results in some subjects. J Drugs Dermatol. 2016;15(5):607-614.

BACKGROUND:Many over the counter topical products claim to reverse the signs of cutaneous photo-damage. To date, the two most studied ingredients for improving the texture, tone, and pigmentation of the skin are topical retinoids and hydroquinone.OBJECTIVE:This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin.METHODS:Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians.RESULTS:Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant's surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement.CONCLUSION:This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.

METHODS In this split-face, evaluator-blinded study, 18 subjects were randomly assigned to receive either the SSR or NFL treatments on each side of the face. For the SSR facial sides subjects followed two morning-evening regimens. On the NFL sides subjects were treated 3 times with the 1927-nm laser at 4-week intervals. Three physician evaluators were asked to rate hyperpigmentation, global photoaging, and ne lines and wrinkles for each side of the face at baseline and at 3 months using a 5-point scale. RESULTS The SSR and NFL treatments provided comparable results for each skin attribute. Improvement from baseline was signi - cant in both treatment programs for each skin attribute. The greatest 3-month improvement for both programs was in hyperpigmen- tation. For global photoaging and ne lines and wrinkles, positive responses were slightly greater in the NFL than in the SSR facial sides. Subject preference for the SSR over the NFL was greatest for ne lines around the eyes, ne lines around the mouth, smooth texture, radiant complexion, and overall improvement while the NFL was preferred for skin rmness and evenness. When the study was completed5 of 18 split-face subjects decided to undergo NFR laser treatment on the non laser treated side along with using the SSR product and 13 of the 18 subjects continued to use the SSR products to their full face after the study. CONCLUSION The mass market skin care system of the present study provides improvement in hyperpigmentation, global photoaging, and ne lines and wrinkles comparable to that of a series of treatments with a non-ablative fractional laser. J Drugs Dermatol. 2016;15(11):1366-1372..