A 12-week clinical and instrumental study evaluating the efficacy of a multisource radiofrequency home-use device for wrinkle reduction and improvement in skin tone, skin elasticity, and dermal collagen content.

This study was performed in order to evaluate the safety and efficacy of a new handheld home-use multisource radiofrequency device on facial rejuvenation. Forty-seven male and female subjects were enrolled. All subjects received a NEWA® 3DEEP™ home-use device (EndyMed Medical, Caesarea, Israel) to be used on facial skin three times per week for the first four weeks and then reduced to two times per week for the following eight weeks. Assessments included expert clinical grading for efficacy, instrumental evaluation, image analysis, and photography. Forty-five subjects completed the study; all subjects reported the treatment to be painless with only mild erythema lasting up to 15 minutes post-treatment. No other adverse events were reported. Statistically significant improvements were noted in the appearance of marionette lines, skin brightness, elasticity, firmness, lift (facial), lift (jawline), texture/smoothness, tone, and radiance/luminosity by expert visual assessment. Statistically significant improvements in skin firmness and elasticity were found using a Cutometer MPA 580, as well as in collagen and hemoglobin content of the skin using a SIAscope. The results of this study indicate that the NEWA® multisource radiofrequency home-use device is effective in self-administered skin rejuvenation.

Home-based wrinkle reduction using a novel handheld multisource phase-controlled radiofrequency device.

BACKGROUND: In the last decade, energy-based aesthetic treatments, using light, radiofrequency (RF), and ultrasound, have gained scientific acceptance as safe and efficacious for non-invasive treatment for aesthetic skin disorders. The phase-controlled multisource radiofrequency technology (3DEEP™), which is based on the simultaneous use of multiple RF generators, was proven to allow significant pigment-independent dermal heating without pain or the need of epidermal cooling. This study was performed in order to evaluate the efficacy and safety of a new handheld device delivering multisource radiofrequency to the skin for wrinkle reduction and skin tightening in the home setting. PATIENTS AND METHODS: A total of 69 participants (age 54.3 years ± 8.09; age range 37-72 years) were enrolled in the study after meeting all inclusion/exclusion criteria (100%) and providing informed consent. Participants were provided with the tested device together with a user manual and treatment diary, to perform independent treatments at home for 4 weeks. The tested device, (Newa™, EndyMed Medical, Cesarea, Israel) emits 12 W of 1Mhz, RF energy through six electrodes arranged in a linear fashion. Independent control of RF polarity through each one of the 6 electrodes allows significant reduction of energy flow through the epidermis with increased dermal penetration. Participants were instructed to perform at least 5 treatments a week, for one month. Four follow-up visits were scheduled (once a week) during the period of independent treatments at home, following 4 weeks of home treatments, 1 month follow-up visit (1 month after treatment end) and at 3 months follow-up (3 months following treatment end). Analysis of pre-and post treatment images was conducted by three uninvolved physicians experienced with the Fitzpatrick Wrinkle and Elastosis Scale. Fitzpatrick Wrinkle and Elastosis score of each time point (4 weeks following home use treatments; 1 month follow-up, 3 months follow-up) was compared to baseline. Participants were asked a series of questions designed to explore usability concerns and level of satisfaction regarding the device use and subjective efficacy. RESULTS: Altogether, 62 subjects completed the study course and follow-up visits. No unexpected adverse effects were detected or reported throughout the independent treatment. All study participants did not experience any difficulties while operating the tested device for independent wrinkle reduction treatments. Photographic analysis of pre- and post-one month of independent home use treatments, and one and three months follow-up after end of treatment course, was conducted by three uninvolved board certified dermatologists. Analysis of results revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 91.93%, 96.77%, and 98.39% of study subjects (according to the first, second, and third reviewer, respectively). Results were found to be statistically significant. The majority of study participants were very satisfied from the results of the independent treatment using the tested device for wrinkle reduction.

In vivo histological evaluation of non-insulated microneedle radiofrequency applicator with novel fractionated pulse mode.

INTRODUCTION: Microneedle radiofrequency is a novel method that allows non-thermal penetration of the epidermis followed by RF coagulation in selected depth of the dermis surrounded by zone of non-coagulative volumetric heating. The first generation of Microneedle RF applicators used insulated needles. These treatments were limited by a few factors, including low volume of dermal heating, lack of effect in the papillary dermis and pinpoint bleeding during the treatment. The system tested in this study (EndyMed PRO, Intensif applicator, EndyMed Medical, Cesarea, Israel) utilizes special extra sharp tapered non-insulated microneedles and a special pulse mode, allowing full coagulation during treatment and higher effective volume of dermal heat. METHODS: After Ethics Committee approval, one female pig (Type Large white X Landrace, 34 Kg) was chosen for the study. The animal was anesthetized using Ketamine, Xylazin and Isofluran. The EndyMed PRO, Intensif applicator (was used for treatment with different needle depth penetration (1 mm-3.5 mm) and in multiple energy settings. Six mm punch biopsies were harvested for histological analysis at the following time points: immediately after the treatment, 4 days after the treatment and 14 days after the treatment. H&E and Masson-Trichrome stains were processed. RESULTS: Visual inspection of the treated skin, immediately after the treatment, revealed arrays of pinpoint erythematous papules surrounded by undamaged epidermal tissue. Treatment field showed no sign of bleeding. Mild to moderate Erythema and Edema developed a few minutes after the treatment, varying according to the total energy delivered. The histologies taken 4-day after therapy showed in all energy settings, dry micro crusts over the treatment zones, with full healing of epidermis. In the 14-day specimens there was a replacement of the crusts/debris by a normal looking stratum corneum with complete healing of epidermis and dermis. DISCUSSION: The current in vivo study confirms that the EndyMed PRO Intensif applicator effective and predictable tool to create cylindrical micro zones of coagulation in the papillary and reticular dermis with minimal damage to the epidermis. The histologies taken 4 days and 14 days after treatment show rapid epidermal renewal with predictable volume of coagulation in dermis related to the length of the needle and the power used. Coagulation of capillaries during treatment allows a dry treatment field. The predictability of the effect and minimal downtime may offer a significant advantage over treatments with ablative fractional lasers of insulated RF microneedles.

In vivo animal histology and clinical evaluation of multisource fractional radiofrequency skin resurfacing (FSR) applicator.

OBJECTIVE: Acne scars are one of the most difficult disorders to treat in dermatology. The optimal treatment system will provide minimal downtime resurfacing for the epidermis and non-ablative deep volumetric heating for collagen remodeling in the dermis. A novel therapy system (EndyMed Ltd., Cesarea, Israel) uses phase-controlled multi-source radiofrequency (RF) to provide simultaneous one pulse microfractional resurfacing with simultaneous volumetric skin tightening. METHODS: The study included 26 subjects (Fitzpatrick's skin type 2-5) with moderate to severe wrinkles and 4 subjects with depressed acne scars. Treatment was repeated each month up to a total of three treatment sessions. Patients' photographs were graded according to accepted scales by two uninvolved blinded evaluators. RESULTS: Significant reduction in the depth of wrinkles and acne scars was noted 4 weeks after therapy with further improvement at the 3-month follow-up. CONCLUSION: Our data show the histological impact and clinical beneficial effects of simultaneous RF fractional microablation and volumetric deep dermal heating for the treatment of wrinkles and acne scars.

Non-invasive therapy of wrinkles and lax skin using a novel multisource phase-controlled radio frequency system.

Abstract The last few years have shown an increased demand for non-invasive skin tightening to improve body contour. Since light (lasers or intense pulsed light sources) has a limited ability to penetrate deep into the tissue, radio frequency (RF) modalities were introduced for the reduction of lax skin to achieve skin tightening and body circumference reduction. This study presents the use of the novel 3DEEP technology for body contouring. 3DEEP is a next generation RF technology that provides targeted heating to deeper skin layers without pain or other local or systemic side effects associated with the use of the earlier generation RF systems available today. The study included 30 treatment areas on 23 healthy volunteers at two sites. The treatment protocol included four weekly and two bi-weekly (n= 6) treatments on different body areas. Results were evaluated by standardized photography and by circumference measurements at the treatment area, and were compared to changes in body weight. Significant improvement could be observed in wrinkles and skin laxity, and in the appearance of stretch marks and cellulite. Some changes appeared as early as after a single treatment. Circumference changes of up to 4.3 cm were measured.

Painless, safe, and efficacious noninvasive skin tightening, body contouring, and cellulite reduction using multisource 3DEEP radiofrequency.

In the last decade, Radiofrequency (RF) energy has proven to be safe and highly efficacious for face and neck skin tightening, body contouring, and cellulite reduction. In contrast to first-generation Monopolar/Bipolar and "X -Polar" RF systems which use one RF generator connected to one or more skin electrodes, multisource radiofrequency devices use six independent RF generators allowing efficient dermal heating to 52-55°C, with no pain or risk of other side effects. In this review, the basic science and clinical results of body contouring and cellulite treatment using multisource radiofrequency system (Endymed PRO, Endymed, Cesarea, Israel) will be discussed and analyzed.

Eradication of Propionibacterium acnes by its endogenic porphyrins after illumination with high intensity blue light.

Propionibacterium acnes is a Gram-positive, microaerophilic bacterium that causes skin wounds. It is known to naturally produce high amounts of intracellular porphyrins. The results of the present study confirm that the investigated strain of P. acnes is capable of producing endogenic porphyrins with no need for any trigger molecules. Extracts from growing cultures have demonstrated emission peaks around 612 nm when excited at 405 nm, which are characteristic for porphyrins. Endogenic porphyrins were determined and quantified after their extraction from the bacterial cells by fluorescence intensity and by elution retention time on high-performance liquid chromatography (HPLC). The porphyrins produced by P. acnes are mostly coproporphyrin, as shown by the HPLC elution patterns. Addition of delta-aminolevulinic acid (ALA) enhanced intracellular porphyrin synthesis and higher amounts of coproporphyrin have been found. Eradication of P. acnes by its endogenic porphyrins was examined after illumination with intense blue light at 407-420 nm. The viability of 24 h cultures grown anaerobically in liquid medium was reduced by less than two orders of magnitude when illuminated once with a light dose of 75 J cm(-2). Better photodynamic effects were obtained when cultures were illuminated twice or three times consecutively with a light dose of 75 J cm(-2) and an interval of 24 h between illuminations. The viability of the culture under these conditions decreased by four orders of magnitude after two illuminations and by five orders of magnitude after three illuminations. When ALA-triggered cultures were illuminated with intense blue light at a light dose of 75 J cm(-2) the viability of the treated cultures decreased by seven orders of magnitude. This decrease in viability can occur even after a single exposure of illumination for the indicated light intensity. X-ray microanalysis and transmission electron microscopy revealed structural damages to membranes in the illuminated P. acnes. Illumination of the endogenous coproporphyrin with blue light (407-420 nm) apparently plays a major role in P. acnes photoinactivation. A treatment protocol with a series of several illuminations or illumination after application of ALA may be suitable for curing acne. Treatment by both pathways may overcome the resistance of P. acnes to antibiotic treatment.

A novel method for real-time skin impedance measurement during radiofrequency skin tightening treatments.

The thermal effects of monopolar and bipolar radiofrequency (RF) have been proven to be beneficial in skin tightening. Nevertheless, these effects were frequently partial or unpredictable because of the uncontrolled nature of monopolar or unipolar RF and the superficial nature of energy flow for bipolar or tripolar configurations. One of the hypotheses for lack or predictability of efficacy of the first-generation RF therapy skin tightening systems is lack of adaptation of delivered power to differences in individual skin impedance. A novel multisource phase-controlled system was used (1 MHz, power range 0-65 W) for treatment and real-time skin impedance measurements in 24 patients (EndyMed PRO™; EndyMed, Cesarea, Israel). This system allows continuous real-time measurement of skin impedance delivering constant energy to the patient skin independent of changes in its impedance. More than 6000 unique skin impedance measurements on 22 patients showed an average session impedance range was 215-584 Ohm with an average of 369 Ohm (standard deviation of 49 Ohm). Analyzing individual pulses (total of 600 readings) showed a significant decrease in impedance during the pulse. These findings validate the expected differences in skin impedance between individual patients and in the same patients during the treatment pulse. Clinical study on 30 patients with facial skin aging using the device has shown high predictability of efficacy (86.7% of patients had good results or better at 3 months' follow-up [decrease of 2 or more grades in Fitzpatrick's wrinkle scale]). The real-time customization of energy according to skin impedance allows a significantly more accurate and safe method of nonablative skin tightening with more consistent and predictable results.

Novel multi-source phase-controlled radiofrequency technology for non-ablative and micro-ablative treatment of wrinkles, lax skin and acne scars.

The basic properties of lasers and pulsed light sources limit their ability to deliver high energy to the dermis and subcutaneous tissues without excessive damage to the epidermis. Radiofrequency was shown to penetrate deeper than optical light sources independent of skin color. The early RF-based devices used single source bipolar RF, which is safe but limited in use due to the superficial flow of energy between the two bipolar electrodes. Another type of single source RF employs a single electrode (monopolar) in which the RF energy flows from one electrode on the surface of the skin through the entire body to a plate under the body. Although more effective than bipolar, this devices require intense active cooling of the skin and may be associated with considerable pain and other systemic and local safety concerns. Latest generation of RF technology developed by EndyMed Medical Ltd. (Caesarea, Israel) utilizes simultaneously six or more phase controlled RF generators (3DEEP technology). The multiple electrical fields created by the multiple sources "repel" or "attract" each other, leading to the precise 3 dimensional delivery of RF energy to the dermal and sub-dermal targets minimizing the energy flow through the epidermis without the need for active cooling. Confocal microscopy of the skin has shown that 6 treatment sessions of Multisource RF technology improve skin structure features. The skin after treatment had longer and narrower dermal papilla and denser and finer collagen fiber typical to younger skin as compared to pre treatment skin. Ultrasound of the skin showed after 6 treatment sessions reduction of 10 percent in the thickness of the subcutaneous fat layer. Non ablative facial clinical studies showed a significant reduction of wrinkles after treatment further reduced at 3 months follow-up. Body treatment studies showed a circumference reduction of 2.9 cm immediately after 6 treatments, and 2 cm at 12 months after the end of treatment, proving long term collagen remodeling effect. Clinical studies of the multisource fractional RF application have shown significant effects on wrinkles reduction and deep atrophic acne scars after 1-3 treatment sessions.

Accelerated reduction of post-skin-resurfacing erythema and discomfort with a combination of non-thermal blue and near infrared light.

The prolonged crusting and erythematic phases following chemical and laser skin resurfacing create discomfort and aggravate patients. Depending on the aggressiveness of the procedure, post-procedure erythema may last from three weeks to several months. iClearXL (CureLight Ltd) is a non-contact, non-thermal blue (405-420 nm)/near infrared (850-900 nm) dual-band light source emitting up to 60 J/cm2 on a 30 cm by 30 cm treatment area. The blue component of the light source has been proven to have a significant anti-inflammatory effect, whereas the near infrared component enhances vascular circulation as well as lymphatic drainage in the thin, necrotized papillary layer. Facial skin laser resurfacing was performed on twelve patients. Starting one day after resurfacing, six patients received a daily 20-minute treatment of blue (405-420 nm)/near infrared (850-900 nm) light for six consecutive days, and six control patients were treated with the usual topical care protocol. Twelve days after the procedure, the treated group had a weighted average erythema score of 0.33 as compared to 1.33 in the control group. Two months after the procedure, the treated group had a weighted average erythema score of 0.16 as compared to 0.83 in the control group. Twelve days after the procedure, the treated group had a weighted average discomfort score of 0.33 as compared to 0.83 in the control group. The tested combination of non-thermal blue (405-420 nm)/near infrared (850-900 nm) dual-band light was found to significantly shorten the duration of post-laser-resurfacing erythema and discomfort with no side effects.

The utilization of nonthermal blue (405-425 nm) and near infrared (850-890 nm) light in aesthetic dermatology and surgery-a multicenter study.

BACKGROUND: A major cause of skin aging is a chronic micro-inflammation triggered by UV radiation and external pollutants. It has been demonstrated that blue light diminishes inflammatory conditions and near infrared light enhances circulation. OBJECTIVES: To assess the effectiveness of a non thermal dual wavelength -- blue (405 - 420 nm) and near infrared (850 - 900 nm) -- light source in skin rejuvenation, in the reduction of the duration of post skin resurfacing erythema and in the acceleration of healing of post surgical conditions (face lift and breast augmentation). METHODS: We have utilized a non contact, hand free dual wavelength light source (iClearXL and Clear100XL, Curelight Ltd) to treat over 60 patients and perform three controlled studies in four centers. Follow up duration was three months. Control group for photo-rejuvenation consisted of patients treated with Glycolic peeling and daily appliance of vitamin C Control group for post skin resurfacing erythema duration consisted of patients untreated by the light source and control group for post surgical healing consisted of patients untreated by the light source or treated by the light source on one side only. RESULTS: Post skin resurfacing erythema duration is reduced by 90%. The healing of post surgical conditions is substantially accelerated and discomfort is reduced. The anti aging effect of the light source includes: reduction of pore size in 90% of patients with stable results at three months follow up, enhanced skin radiance in 90% of patients with stable results at three months follow up and smoothing of fine wrinkles in 45% of patients with stable results at three months follow up. The control group showed poor results which were stable for a duration of less than one month. CONCLUSIONS: A non thermal, non contact / hand free light source emitting at 405-420 nm and 850-900 nm considerably enhances aesthetic and surgical aesthetic procedures without consuming user time.

The effective treatment of acne vulgaris by a high-intensity, narrow band 405-420 nm light source.

BACKGROUND: Available topical treatments are slow and frequently irritating. Oral therapies may be associated with increased bacterial resistance (antibiotics) or possible severe side effects (oral isotretinoin). In vitro and in vivo exposure of acne bacteria to 405-420 nm ultraviolet (UV) free blue light results in the photo-destruction of these bacteria through the effects on the porphyrins produced naturally by Propionibacterium acnes. A novel, high-intensity, narrow band 420 nm UV free blue light has been shown to decrease inflammatory acne lesions after eight bi-weekly treatments. OBJECTIVES: To examine the effects of high-intensity, narrow band 420 nm UV free blue light (ClearLight) on inflammatory acne lesions. METHODS: Three studies were carried out to examine the clinical effects of high-intensity, narrow band blue light on papulo-pustular acne: the split-face dose-response study, the full-face open trial and the split-face, double-blind controlled study. The studies enrolled 10, 13 and 23 patients respectively. RESULTS: The data show more than an 80% response to 420 nm acne phototherapy with a significant reduction of 59-67% of inflammatory acne lesions after only eight treatments of 8-15 minutes. The reduction in lesions was steady in the follow-ups at 2, 4 and 8 weeks after the end of therapy. Prolonged remission was evident in the 8 weeks after the end of therapy. No adverse effects or patient discomfort were noted in any of the patients. CONCLUSIONS: Acne phototherapy by high intensity, narrow band 405-420 nm light is proven to be an attractive, fast, effective, non-invasive alternative to current topical and parenteral anti-acne remedies.