Radiofrequency Heating and High-Intensity Focused Electromagnetic Treatment Delivered Simultaneously: The First Sham-Controlled Randomized Trial.

BACKGROUND: Radiofrequency-based and high-intensity focused electromagnetic (HIFEM)-based devices have proved effective and safe for abdominal body shaping. Radiofrequency is known to reduce adipose tissue, whereas HIFEM treatment is effective for muscle definition. The authors investigated the efficacy of a novel device delivering synchronized radiofrequency and HIFEM treatment simultaneously for abdominal toning and fat reduction. METHODS: Seventy-two patients were enrolled and randomly divided into active (n = 48; age, 45.5 ± 13.0 years) and sham groups (n = 24; age, 44.6 ± 12.3 years). Both groups received three treatments on the abdomen once a week. The intensity in the active group was set to maximum tolerable level; in the sham group, the intensities were set to 5 percent. Ultrasound images were taken before treatment and at 1, 3, and 6 months after treatment to examine changes in subcutaneous fat and rectus abdominis muscle thickness. Digital photographs were taken, and satisfaction and therapy comfort were assessed. RESULTS: Ultrasound images of the active group at 1 month showed significant (p < 0.05) reduction in adipose tissue thickness by 20.5 percent (4.8 ± 2.6 mm), whereas rectus abdominis muscle thickness increased by 21.5 percent (2.0 ± 0.8 mm). Results at 3 months improved to 28.3 percent (7.6 ± 3.7 mm) and 24.2 percent (2.3 ± 0.9 mm), respectively. Improvements were maintained at 6 months after treatment in the active group, whereas the sham group showed no significant changes. Treatments were found to be comfortable. The active group showed higher satisfaction with outcomes. CONCLUSION: Active treatment utilizing simultaneous application of radiofrequency and HIFEM therapy resulted in a significant increase in rectus abdominis thickness and subcutaneous fat reduction, exceeding previously published results for separate HIFEM and radiofrequency treatments. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Simultaneous Application of High-Intensity Focused Electromagnetic and Synchronized Radiofrequency for Fat Disruption: Histological and Electron Microscopy Porcine Model Study.

BACKGROUND: Radiofrequency (RF) and high-intensity focused electromagnetic (HIFEM) technologies are used for noninvasive body shaping as standalone modalities. OBJECTIVE: To examine the effects of novel synchronized RF and HIFEM on subcutaneous adipose tissue in a porcine animal model. MATERIALS AND METHODS: Seven large white pigs aged 6 months received 3 abdominal treatments of simultaneous application of synchronized RF and HIFEM (30 minutes, once per week). Punch biopsies of treated and control subcutaneous tissue were collected at the baseline, 4 days, 2 weeks, 1 month, and 2 months. Specimens were examined by light and scanning electron microscopy. Adipocyte volume was analyzed. Fat tissue temperature was measured in situ (fiber optic probes) and superficially (thermal imager). RESULTS: Fat layer was heated to temperatures of 42 to 45°C. Signs of fat apoptosis (shape alternations and pyknotic nuclei) appeared at day 4 and peaked between 2 weeks and 1 month. Adipocyte volume decreased significantly (p < .001) by 31.1% at 2 weeks, 1 month (-23.6%), and 2 months (-22.0%). Control samples showed healthy adipocytes. Scanning electron microscopy micrographs corroborated histology findings, showing flattened, volume-depleted and disrupted adipocytes. CONCLUSION: Synchronized RF with HIFEM procedure resulted in a significant and sustained fat reduction with no adverse events.

Safety of Combination Laser or Intense Pulsed Light Therapies and Doxycycline for the Treatment of Rosacea.

BACKGROUND: Current treatment options for rosacea include topical agents, oral therapies, phototherapy using lasers, or intense pulsed light (IPL). Combination therapy for rosacea often yields better results than monotherapy. The safety of laser/light treatments in combination with systemic doxycycline has been questioned because of the theoretical risk of photosensitivity. OBJECTIVE: The purpose of this study was to assess the incidence of phototoxicity or photosensitivity in rosacea patients receiving concomitant laser or light treatments and systemic doxycycline. METHODS: Treatment records of 36 patients receiving laser/light treatments while also being treated with standard dose or anti-inflammatory dose of doxycycline were retrospectively reviewed. RESULTS: No adverse reactions related to doxycycline combined with laser/light therapy were reported. Specifically, no photosensitivity or sensitivity to wavelengths in the pulsed dye laser (PDL), or IPL range was observed in this cohort. All patients achieved some degree of clearance. CONCLUSION: The results of this retrospective study demonstrate that doxycycline used in conjunction with laser or nonlaser light therapy is a valid combination therapy for improving signs and symptoms of rosacea. No photosensitivity reactions were observed to commonly used IPL or PDL devices.

Induction of fat apoptosis by a non-thermal device: Mechanism of action of non-invasive high-intensity electromagnetic technology in a porcine model.

OBJECTIVES: While controlled thermal changes in subcutaneous tissue have been used to trigger apoptosis of fat cells and have been proven clinically efficacious, another mechanism of electromagnetic stress suggests that fat apoptosis could be achieved by a non-thermal manner as well. This animal model study investigates the use of a non-invasive high-intensity magnetic field device to induce apoptosis in fat cells. METHODS: Yorkshire pigs (N = 2) received one treatment (30 minutes) in the abdominal area using a High-Intensity Focused Electromagnetic (HIFEM) device. Punch biopsy samples of fat tissue and blood samples were collected at the baseline, 1 and 8 hours after the treatment. Biopsy samples were sectioned and evaluated for the levels of an apoptotic index (AI) by the TUNEL method. Statistical significance was examined using the rANOVA and Tukey's test (α 5%). Biopsy samples were also assessed for molecular biomarkers. Blood samples were evaluated to determine changes related to fat and muscle metabolism. Free fatty acids (FFA), triacylglycerol (TG), glycerol and glucose (Glu) were used as the main biomarkers of fat metabolism. Creatinine, creatinine kinase (CK), lactate dehydrogenase (LDH) and interleukin 6 (IL6) served as the main biomarkers to evaluate muscle metabolism. RESULTS: In treated pigs, a statistically significant increase in the apoptotic index (AI) (P = 1.17E-4) was observed. A significant difference was found between AI at baseline (AI = 18.75%) and 8-hours post-treatment (AI = 35.95%). Serum levels of fat and muscle metabolism indicated trends (FFA -0.32 mmol · l-1 , -28.1%; TG -0.24 mmol · l-1 , -51.8%; Glycerol -5.68 mg · l-1 , -54.8%; CK +67.58 µkat · l-1 , +227.8%; LDH +4.9 µkat · l-1 ,+35.4%) suggesting that both adipose and muscle tissue were affected by HIFEM treatment. No adverse events were noted to skin and surrounding tissue. CONCLUSIONS: Application of a high-intensity electromagnetic field in a porcine model results in adipocyte apoptosis. The analysis of serum levels suggests that HIFEM treatment influences fat and muscle metabolism. Lasers Surg. Med. 51:47-53, 2019. © 2018 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Safety and efficacy of a novel diffractive lens array using a picosecond 755 nm alexandrite laser for treatment of wrinkles.

INTRODUCTION: Picosecond lasers have been reported to be effective for removal of tattoo pigment. This prospective study evaluated the efficacy and safety of the treatment of peri-oral and -ocular wrinkles using a novel diffractive lens array coupled with a picosecond 755 nm alexandrite laser. METHODS: Forty female subjects presenting with wrinkles from photodamage were enrolled in an IRB approved study. Subjects received four picosecond diffractive lens array treatments to the full face at 1 month intervals. Six subjects were biopsied (two subjects at 1 month, two subjects at 3 months, and two subjects at 6 months). Digital photographic images were taken at 1, 3, and 6 months post-final treatment visits. Images were graded by blinded physicians for fine lines/wrinkles, erythema, dyschromia, and global improvement. Data on discomfort level, satisfaction, and side effects were recorded. RESULTS: Overall blinded physician rated global improvement ranged from improved to much improved at 1-, 3-, and 6-month time points. At baseline the average Fitzpatrick wrinkle score was 5.48. At the 6-month follow-up the average score was 3.47. The overall average change in score from pre-treatment to post-treatment was 1.97. Subject self-assessment at 6 months indicated that 90% of subjects were extremely or satisfied with their results. Unanticipated adverse events were absent with anticipated post-treatment erythema lasting for just several hours. CONCLUSIONS: A novel diffractive lens array used with a picosecond 755 nm alexandrite laser for treatment of wrinkles is highly effective and safe for wrinkles and other signs of photoaging. Lasers Surg. Med. 49:40-44, 2017. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals, Inc.

Reduction in thigh circumference and improvement in the appearance of cellulite with dual-wavelength, low-level laser energy and massage.

OBJECTIVES: This study evaluated the efficacy and safety of a low-level, dual-wavelength laser energy and massage device for improving the appearance of cellulite and reducing thigh circumference. METHODS: Subjects (n = 83) with mild to moderate cellulite enrolled in this IRB-approved, open-label, multicenter study. Their right or left thighs received eight treatments with a low-level, dual-wavelength laser and massage device. The untreated contralateral thigh served as a control. Circumferences of the upper, middle, and lower thighs (treated and untreated) were measured before the fifth and eighth treatments and 1 month after the final treatment. RESULTS: Reduction in thigh circumference of the treated areas exceeded those of the control areas for the upper, middle, and lower thigh in most subjects. The maximum reduction (-0.82 cm) occurred in the upper thigh at 1 month. The mean reduction of the upper, middle, and lower thigh circumferences was -0.64 cm for the treated thighs compared to -0.20 cm for untreated thighs. The difference was significant (p < 0.0001). Fifty-nine (71.1%) treatment thighs lost circumference compared to 44 (53.0%) control thighs. Resolution of adverse effects including erythema, swelling, and increased urination was seen within 30 minutes after treatment. All were resolved without sequelae and within the expected duration. CONCLUSION: The low-level, dual-wavelength laser energy and massage device safely improves the appearance of cellulite while reducing thigh circumference.

Evidence for laser- and light-based treatment of acne vulgaris.

Acne is a very prevalent skin disorder, affecting more than 85% of adolescents and often continuing into adulthood. Active acne and its sequelae, especially permanent scarring, may cause longstanding psychological or emotional harm in patients. Novel and promising treatments with laser/light devices (such as blue light, red light, pulsed dye laser, infrared lasers, light-emitting diodes, and pulsed light) have been reported to have varying degrees of efficacy for treatment. The authors compiled a summary of evidence-based literature on laser/light treatment for acne to assist clinicians to more appropriately identify treatment options, should they choose to supplement current medical antiacne therapies.

Treatment of radiation-induced dermatitis with light-emitting diode (LED) photomodulation.

BACKGROUND AND OBJECTIVE: Light-emitting diode (LED) photomodulation increases dermal collagen and reduces inflammation. This study evaluated the use of LED photomodulation in the prevention of radiation-induced dermatitis in breast cancer. MATERIALS AND METHODS: Patients (n=19) were treated with LED photomodulation (Gentlewaves, Light BioScience, LLC, Virginia Beach, VA) after each of a series of intensity-modulated radiation treatments (IMRT). Skin reactions were monitored weekly with National Cancer Institute (NCI) criteria. Age-matched controls (n=28) received IMRT without LED photomodulation. RESULTS: In LED-treated patients, 18 (94.7%) had grade 0 or 1 reaction and 1 (5.3%) had grade 2 reaction. Among controls, 4 (14.3%) had a grade 1 reaction, 24 (85.7%) had a grade 2 or 3 reaction. One LED-treated patient (5.3%) and 19 controls (67.9%) had to interrupt treatment. CONCLUSION: LED photomodulation treatments immediately after IMRT reduces the incidence of NCI grades 1, 2, and 3 skin reactions in patients with breast cancer treated by radiation therapy (RT) postlumpectomy.

Intense pulsed light as a nonablative approach to photoaging.

BACKGROUND AND OBJECTIVE: To describe the introduction and use of intense pulsed light (IPL) to treat vascular and pigmented lesions comprising photorejuvenation and its use in photodynamic therapy. METHODS: Review of the medical literature and the authors' experience with IPL. RESULTS AND CONCLUSIONS: IPL is an excellent treatment modality for vascular and pigmented manifestations of photoaging and can be combined with photodynamic therapy for the treatment of early forms of skin cancer.

Clinical experience with light-emitting diode (LED) photomodulation.

BACKGROUND: Light-emitting diode (LED) photomodulation is a novel nonthermal technology used to modulate cellular activity with light. OBJECTIVE: We describe our experience over the last 2 years using 590 nm LED photomodulation within a dermatologic surgery environment. METHODS: Practical use of nonthermal light energy and emerging applications in 3,500 treatments delivered to 900 patients is detailed. RESULTS: LED photomodulation has been used alone for skin rejuvenation in over 300 patients but has been effective in augmentation of results in 600 patients receiving concomitant nonablative thermal and vascular treatments such as intense pulsed light, pulsed dye laser, KTP and infrared lasers, radiofrequency energy, and ablative lasers. CONCLUSION: LED photomodulation reverses signs of photoaging using a new nonthermal mechanism. The anti-inflammatory component of LED in combination with the cell regulatory component helps improve the outcome of other thermal-based rejuvenation treatments.

Comparison of intense pulsed light to 595-nm long-pulsed pulsed dye laser for treatment of hypertrophic surgical scars: a pilot study.

BACKGROUND: The short-pulsed pulsed dye laser (PDL) has been previously reported to improve the appearance of hypertrophic scars. Prolonged purpura following treatment led to the development of the newer long-pulsed pulsed dye laser (LPDL). Intense pulsed light (IPL) has been extensively used to improve the various components of photo damage and to reduce the incidence of purpura, but its effect on scars has not been analyzed. The objective of this pilot study was to prospectively determine and compare the safety and efficacy of LPDL and IPL on surgically induced scars. METHODS: Breast reduction scars (N = 10 scars) and abdominoplasty scars (N=5 scars) were treated using both LPDL and IPL. For breast reduction scars, one side was treated with each technique. For abdominoplasty scars, one half of the scar was treated with each device. Two treatments were performed 2 months apart. Physician global assessment scores of improvement were determined by side-by-side comparison of preoperative and randomly presented postoperative photographs. Patient pain scores during treatment were also obtained and the presence of post, treatment purpura was assessed. RESULTS: Mean improvement on a 0 to 3 point scale was 2.2 (55%) after the first LPDL treatment and 3.2 (80%) after the second. Mean improvement was 1.8 (45%) after the first IPL treatment and 2.6 (65%) after the second. Differences in improvement between the LPDL and IPL sides were not statistically significant. Patients rated IPL as more painful than LPDL. The incidence of post-treatment purpura was lower with IPL. CONCLUSIONS: This pilot study suggests that LPDL and IPL are equally effective in improving the appearance of hypertrophic surgical scars. IPL offers a novel method of treating scars that minimizes the risk of purpura.

Our approach to non-ablative treatment of photoaging.

BACKGROUND AND OBJECTIVES: Many laser, light and energy emitting devices are utilized for skin rejuvenation. STUDY DESIGN/MATERIALS AND METHODS: The clinical approach to multiple problems of photoaging are discussed and an algorithm for approach by problem is presented. RESULTS: Clinical use of various modalities such as LED photomodulation, intense pulsed light, pulsed dye laser, KTP laser, radiofrequency and fractional resurfacing are presented with successful parameters, developed over several years, utilized on a daily basis in a busy cosmetic dermatology clinic. CONCLUSIONS: Significant improvement in the appearance of signs and symptoms of photoaging, including telangiectasias, mottled pigmentation, irregular surface texture, wrinkling and skin sagging can achieved by relatively non-invasive means.

Clinical trial of a novel non-thermal LED array for reversal of photoaging: clinical, histologic, and surface profilometric results.

BACKGROUND AND OBJECTIVES: Photomodulation has been described as a process which modifies cell activity using light sources without thermal effect. The objective of this study was to investigate the use of a non-thermal low dose light emitting diode (LED) array for improving the appearance of photoaged subjects. STUDY DESIGN/MATERIALS AND METHODS: This prospective study investigated a random cohort of patients (N = 90) with a wide range of photoaged skin treated by LED photomodulation using a full panel 590 nm non-thermal full face LED array delivering 0.1 J/cm(2) with a specific sequence of pulsing. Subjects were evaluated at 4, 8, 12, 18 weeks and 6 and 12 months after a series of 8 treatments delivered over 4 weeks. Data collected included stereotactic digital imaging, computerized optical digital profilometry, and peri-ocular biopsy histologic evaluations for standard stains and well as collagen synthetic and degradative pathway immunofluorescent staining. RESULTS: Digital imaging data showed a reduction of signs of photoaging in 90% of subjects with smoother texture, reduction of peri-orbital rhytids, and reduction of erythema and pigmentation. Optical profilometry showed a 10% improvement by surface topographical measurements. Histologic data showed markedly increased collagen in the papillary dermis of 100% of post-treatment specimens (N = 10). Staining with anti-collagen I antibodies demonstrated a 28% (range: 10%-70%) average increase in density while staining with anti-matrixmetalloproteinase (MMP)-1 showed an average reduction of 4% (range: 2%-40%). No side effects or pain were noted. CONCLUSIONS: Photomodulation to reverse photoaging is possible with a specific array of LEDs with a specific fluence using a precise pulsing or "code" sequence. Skin textural improvement by digital imaging and surface profilometry is accompanied by increased collagen I deposition with reduced MMP-1 (collagenase) activity in the papillary dermis. This technique is a safe and effective non-painful non-ablative modality for improvement of photoaging.

Endovenous ablation of truncal veins.

The use of endovenous procedures to eliminate saphenous and primary branch reflux has been growing exponentially over the last few years. Although initially developed by dermatologic surgeons, the technique has been embraced by many other specialties including radiology, vascular surgery and anesthesiology. Radiofrequency energy was the first used in 1999 for endovenous ablation. More recently, laser technology targeting hemoglobin (810 nm, 940 nm & 980 nm) and water (1320 nm) have been developed to quickly and effectively treat saphenous reflux, with minimal side effects. The placement of peri-vascular anesthesia, using the tumescent technique, has further streamlined these procedures. The purpose of this article is to review our experience and outline advantages and disadvantages of the various techniques available.

A novel non-thermal non-ablative full panel LED photomodulation device for reversal of photoaging: digital microscopic and clinical results in various skin types.

Photomodulation is a process that manipulates or regulates cell activity using light sources without thermal effect. Previous studies of LED photomodulation have shown skin textural improvement accompanied by increased collagen deposition with reduced MMP-1 (collagenase) activity in the papillary dermis. The purpose of this study was to investigate a separate cohort of patients (N =93) with a wide range of Fitzpatrick skin types treated by LED photomodulation using the Gentlewaves full panel 590 nm high energy LED array with a specific sequence or code of pulsing in the millisecond domain. Results showed improvement of signs of photoaging in 90%. The majority of patients demonstrated improvement in peri-ocular wrinkles, reduction in Fitzpatrick photoaging classification, global skin texture and background erythema, and pigmentation. No side effects were noted. LED photomodulation is a safe and effective non-painful non-ablative modality for improvement of photoaging.

Review of nonablative photorejuvenation: reversal of the aging effects of the sun and environmental damage using laser and light sources.

This review article outlines all the latest light or electromagnetic radiation based technologies used for nonablative skin rejuvenation. While many technologies have been available for a number of years, emerging technologies are also discussed, which may play a role in treatment of photoaged skin in the very near future. The principles behind these technologies are discussed in detail.

Rejuvenation of photoaged skin: 5 years results with intense pulsed light of the face, neck, and chest.

BACKGROUND: Photorejuvenation involves the use of lasers or light sources to reverse signs of photoaging. Multiple devices have been shown to be effective over the short-term. OBJECTIVE: To investigate the long-term clinical results on the face, neck and chest at 4 years using filtered flashlamp intense pulsed light (IPL) for treatment of photoaging changes of telangiectasias, dyspigmentation, and rough skin texture. METHODS: A chart review of 80 randomly selected patients with skin types I-IV who were treated by IPL during 1996 and 1997 was performed. Photos and patient self-assessment were graded for features of textural smoothness, telangiectasia severity, and blotchy pigmentation into four categories of worse, no change, slightly better (less than 50% improvement) and much better (greater than 50% improvement). RESULTS: At 4 years following initial treatment, skin textural improvement was noted in 83% of the subjects. Telangiectasias were improved in 82% of subjects, while pigmentation remained improved in 79%. The median number of treatments was 3. The face responded slightly better than the chest or neck. Most common side-effects included temporary mild crusting (19%), erythema (15%) and purpura (6%). CONCLUSION: Signs of photoaging including telangiectasias and mottled pigmentation of the face, neck, and chest, can be improved by IPL with a long-lasting result. Minimal or no downtime with minimal adverse effects can be achieved with the settings reported. Skin textural smoothing, although not easily quantified, is an additional benefit observed long-term.

Short-term histologic effects of nonablative resurfacing: results with a dynamically cooled millisecond-domain 1320 nm Nd:YAG laser.

BACKGROUND: It is widely believed that nonablative laser techniques can lead to dermal collagen remodeling without the obvious epidermal injury and the wound created with ablative approaches. This occurs when dermal collagen injury is induced without visible injury to the overlying epidermis. OBJECTIVE: To examine the acute histologic effects both 1 hour and several days after standardized treatment protocols of dynamically cooled millisecond domain Nd:YAG 1320 nm laser to provide further insight into the mechanism of action of nonablative resurfacing. METHODS: Multiple adjacent sites on the preauricular area of the cheek of 10 patients were biopsied following one to three laser passes of dynamically cooled millisecond-domain Nd:YAG 1320 nm laser. Biopsies were performed at 1 hour and at 3 days following a single treatment. The number of passes was varied from one to three and Tmax (peak temperature measured by integrated radiometer) during treatment was targeted for 45-48 degree C. RESULTS: At 1 hour after treatment, epidermal spongiosis and edema of the basal cell layer were present in all the specimens treated with three passes. At 3 days the three pass samples also showed microthrombosis, widened vessels, sclerosis of the vessel walls, and infiltration of neurophilic granulocytes. The occurrence of these histologic findings correlated well with the presence of clinical improvement (judged by photographs) at 8 weeks after treatment. Acute histologic changes and clinical improvement were not observed below treatment temperatures of Tmax 45 degree C or after one pass alone. Repeated temperatures above a Tmax of 48 degree C incurred risk of epidermal injury. CONCLUSION: Even though longer-term histologic findings have confirmed the collagen synthesis component of 1320 nm Nd:YAG laser, our data indicate that there may be some additional factors other than dermal collagen heating with subsequent collagen repair. The concept of true "nonablative resurfacing" may involve some form of subclinical epidermal injury that improves the clinical outcome. Acute changes involving superficial blood vessel injury with cytokine release may also be implicated. Our histologic findings suggest that three passes with fluence and cooling adjusted to a Tmax of 45 degree C-48 degree C yields improved clinical results.