Article

Home-use TriPollar RF device for facial skin tightening: Clinical study results

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Abstract

Professional, non-invasive, anti-aging treatments based on radio-frequency (RF) technologies are popular for skin tightening and improvement of wrinkles. A new home-use RF device for facial treatments has recently been developed based on TriPollar™ technology. To evaluate the STOP™ home-use device for facial skin tightening using objective and subjective methods. Twenty-three female subjects used the STOP at home for a period of 6 weeks followed by a maintenance period of 6 weeks. Facial skin characteristics were objectively evaluated at baseline and at the end of the treatment and maintenance periods using a three-dimensional imaging system. Additionally, facial wrinkles were classified and subjects scored their satisfaction and sensations. Following STOP treatment, a statistically significant reduction of perioral and periorbital wrinkles was achieved in 90% and 95% of the patients, respectively, with an average periorbital wrinkle reduction of 41%. This objective result correlated well with the periorbital wrinkle classification result of 40%. All patients were satisfied to extremely satisfied with the treatments and all reported moderate to excellent visible results. The clinical study demonstrated the safety and efficacy of the STOP home-use device for facial skin tightening. Treatment can maintain a tighter and suppler skin with improvement of fine lines and wrinkles.

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... After title and abstract screening, a total of 33 studies were defined as ineligible, and 42 studies were considered eligible. The final number of included studies was 21 articles after the reading of full texts and screening of inclusion criteria (17,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41). Figure 1 shows the flow diagram according to PRISMA guidelines (21). Table 1 summarizes the general characteristics of the studies included in the present review. ...
... Table 1 summarizes the general characteristics of the studies included in the present review. One study is from Japan (34), one study from the Philippines (22), two studies from China (17,27), two studies from France (36,41), one study from the Republic of Korea (38), one study from Israel (30), nine studies from the USA (23,24,28,33,35,37,39,40), one study from Brazil (26), one study from Italy (29), one study from Poland (25) and one was a multicentre study in which treated patients were from Japan and the USA (32). ...
... The age of the participants ranged from 20 (38) to 90 years (34). Ten studies recruited only female volunteers (17,23,25,26,27,29,37,38,40,41) and eleven recruited females and males (22,23,28,30,31,32,33,34,35,36,39). ...
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... Radiofrequency (RF) devices stimulate fibroblast collagen production [4]. We identified 1 RCT of home-based RF for rhytides and wrinkles [31]. ...
... Home-based RF devices also demonstrated efficacy and a favorable safety profile for the treatment of rhytides and wrinkles. In addition to the RF studies cited in the results section, non-RCT clinical studies also exhibited statistically significant improvement in wrinkle volume and skin laxity [4,5]. We selected a B recommendation for the RF devices included in this review. ...
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... There are now numerous published studies reporting the treatment efficacy of low radiant exposure, lightbased therapy for many of the above mentioned conditions, often as a substitute for prescription drug therapy [1,2,3,4,5,6] including examples of homebased / routine consumer use of directed energy devices [7,8,9,10,11]. ...
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The recent development of light-based laser and intense light devices for consumer use with or without physician direction has raised new challenges in safety standards and regulatory requirements for these appliances. Home-use laser products have emission levels from “embedded” lasers that would ordinarily result in their having laser hazard classifications of 3B or 4, but because of design features and interlocks, cannot emit radiation which is hazardous to the eye when the product is in contact with the skin. When not in contact with the skin, emission is normally disabled anyway. With no outside emission, safety control measures in current horizontal standards do not make much sense. The International Electrotechnical Commission (IEC) has therefore defined a new laser Class 1C in its draft revisions to IEC standard 60825-1. Since laser appliances of laser Class 1C are diverse products, safety requirements may be too general if contained in the horizontal laser safety standard. Therefore, the general IEC 60825-1 only allows laser Class 1C to be attributed by a manufacturer to it’s product when a vertical safety standard exists which contains specific safety requirements which cover eye and skin hazards posed by the respective product (such as appliances for hair removal and skin rejuvenation). Whilst no equivalent ocular hazard generally arises with home-use intense light sources (ILS), higher Risk Group “embedded” ILS sources which pose a risk for the skin could conceivably be employed in home-use devices for certain applications (e.g. acne therapy). If this new laser classification is approved, the vertical standards will specify the appropriate design, engineering, reliability, test methods, labelling and instructional controls required for safe consumer use. This paper gives an overview of the recent state of development of a vertical standard which includes lasers categorized laser Class 1C, in the IEC 60335 series.
... There are now numerous published studies reporting the treatment efficacy of low radiant exposure, lightbased therapy for many of the above mentioned conditions, often as a substitute for prescription drug therapy [1,2,3,4,5,6] including examples of homebased / routine consumer use of directed energy devices [7,8,9,10,11]. ...
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The ThermaCool TC system is a radiofrequency device capable of delivering higher energy fluences to a greater volume of tissue than nonablative lasers, with no epidermal injury. It has been successful in treating periorbital rhytides and lifting eyebrows. Given these positive finding for treatment of the upper face, the device has been recently applied to rejuvenate and tighten the skin on the lower face and upper neck. This study shows the efficacy and patient satisfaction with this application. Data were compiled over a 6-month period from patients treated with the ThermaCool TC system on the lower face. Up to 3 areas were treated: cheeks, jawline, and upper neck. Treatment parameters and adverse events were recorded and digital photographs taken. Telephone interviews were then conducted after the treatment to assess patient satisfaction. Sixteen patients underwent treatment of the lower face during this period. Eleven of the patients had all three areas (cheeks, jawline, and neck) treated. Two patients had only the cheeks and jawline treated, and 3 patients underwent treatment of the cheeks only. The average level was 14.6 for the cheeks with the average energy of 113.8 joules per pulse. The average treatment level of the jawline was 14.0, with the average energy of 107.0 joules per pulse. The average level was 13.8 for the neck, at the average energy of 99.7 joules per pulse. All patients experienced mild erythema and edema of the treatment areas as expected, and all resolved within 48 hours post-treatment. Fifteen of the 16 patients were available for interview. Ten patients found the results unsatisfactory while five patients were satisfied. Four of 11 (36%) patients who had all 3 areas treated reported satisfactory results, compared to 1 of 4 (25%) of patients who had only 1 or 2 areas treated. The satisfactory group consistently was higher in both dial setting and energy per pulse. Furthermore, the average age of the unsatisfactory group was 58, compared to 51 of the satisfactory group. Photographic analysis of pre- and post-treatment digital images did not yield statistically significant results. Our study adds the growing body of information on this new device. Radiofrequency causes movement of charged particles within the tissue, and the resultant molecular motion generates heat. The heat in turn causes collagen shrinkage and new collagen deposition. Based on our findings, younger patients tend to respond better. This is not surprising, since heat-labile collagen bonds are progressively replaced by irreducible multivalent cross-links as the tissue ages. Second, higher dial settings and corresponding higher energy per pulse correlated with better response. Third, those who had the entire surface area of the face and neck treated tend to do better than those with partial treatment. The data from the study give us critical clues in refining this exciting new technology for cosmetic uses and beyond.
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Reduction of wrinkles is increasingly becoming one of the most sought after aesthetic procedures. A variety of treatment modalities are available for this application, including radiofrequency energy in various modes of action. The goal of the reported study was to evaluate the safety and efficacy of a new device, which implements an innovative combination of bipolar radiofrequency and vacuum. Forty-six healthy adults at two clinics underwent eight facial treatments every 1 to 2 weeks. For 6 months after treatment, patients were assessed directly by two evaluators at each clinic (the treating physician and an additional reviewer) using standard evaluation tools-the Fitzpatrick-Goldman Classification of Wrinkling and Degree of Elastosis and a visual analog scale. Significant improvement in the skin's appearance and texture was observed during the treatment course and continued to increase during the follow-up period. The mean elastosis score on the wrinkling and elastosis scale before treatment was 4.5 and was reduced to less than 2.5 by 6 months after treatment, representing a drop of an entire wrinkle class (from II to I) on this scale. The reported pain levels were low, and the subjects expressed their satisfaction with the treatment and its outcome. The adverse responses consisted mainly of transient erythema and burn/blistering; there were also a few occurrences of edema, purpura, and crusting and one transient hyperpigmentation. No permanent complications had occurred. Our results demonstrate the safety and efficacy associated with use of this radiofrequency and vacuum device, employing Functional Aspiration Controlled Electrothermal Stimulation (FACES) technology, for reduction of facial wrinkles and elastosis.
Article
Recently, radiofrequency (RF) devices have been introduced and commercialized for nonablative procedures in dermatology and plastic surgery for the treatment of age-related rhytides and lax skin. The objective was to assess the efficacy and safety of a novel RF device (Accent, Alma Lasers, Ltd, Caesarea, Israel) for the treatment of rhytides and lax skin. Sixteen female patients (age range, 29-66 years; mean, 47+/-6 years; skin phototypes II to IV) were treated with Accent system. Patients were treated on the chin (n=5), forehead (n=8), cheeks (n=12), jowl lines (n=9), periorbital area (n=7), marionette line (n=3), and nasolabial folds (n=6) for wrinkles (n=27 cases) and skin laxity (n=23 cases). Patients received two to six treatments (mean, 4.3+/-1.1), with the time interval of 2 to 3 weeks. Photographs were assessed 1 month after the last treatment. RESULTS For wrinkles and skin laxity, in 5 patients (42%), the cheeks (n=12) scored 51% to 75% (significant improvement), and 2 patients (17%), 76% to 100% (excellent improvement). For the jowl lines (n=9), 4 patients (44%) scored 51% to 75% (significant improvement), and 1 patient scored 76% to 100% (excellent improvement) for lax skin. For wrinkles on the periorbital (n=7) and forehead areas (n=8), three patients (37%) scored 51% to 75% (significant improvement). The Accent system is an effective and safe modality for the improvement of age-related rhytides and lax skin.
Article
The use of radiofrequency (RF) for selective electro-thermolysis has been found to produce a highly efficient thermal effect on biological tissue. Different from optical energy, RF energy is dependent on the electrical properties of the tissue rather than on concentration of chromophores in the skin for selective thermal destruction of targeted sites. Good results have been obtained with systems that use RF current alone for skin resurfacing, with efficacy comparable to laser resurfacing but with potentially more rapid healing. A related adverse effect is pain accompanying the procedure, due to a high depth of penetration. Another technology integrates RF energy together with optical energy (using lower energies of both forms of energies). These systems have shown efficacy in hair removal for all hair colors and skin types, as well as wrinkle reduction; and may reduce the risk of side effects associated with either RF or optical treatments alone. This article discusses the properties of electrical current in medicine and reviews the studies to date that have evaluated RF energy for dermatological applications.
Article
The global and systematic demonstration for the practical usage of a direct three-dimensional in vivo measurement system (PRIMOS) to evaluate wrinkles was investigated. Ten repetitive measurements of the corner of the eye of a subject showed that the coefficient of variation (CV)% value was 7.0% in a typical line-length roughness parameter Ra (the arithmetic mean of roughness), and that the CV% value in a typical surface area roughness parameter Sa was 2.4%. The relationships between the roughness values obtained from the corners of the eye and the age or wrinkle scores of Japanese women aged 10-70 years was examined. The values of several roughness parameters within the evaluation line length or surface area increased with age and showed a good correlation coefficient (r > 0.743). Similar relationships between the wrinkle scores and the values of roughness parameters were observed (r > 0.699). The roughness values were widely distributed even in the same wrinkle score because the measurement areas were limited and the values of skin roughness, including the microreliefs and/or small warts, were included in the calculation. However, changes in roughness values are considerable following treatment with potent active ingredients such as retinoic acid, so that this in vivo evaluation method is sufficient to objectively evaluate wrinkles. We conclude that the direct three-dimensional analysis of wrinkles in vivo should become a popular method to objectively evaluate wrinkles in clinical tests of wrinkle-smoothing ingredients or following cosmetic surgery to provide evidence of quantitative results.
Atlas du vieillissement cutan é , Volume 1: Population europ é enne
  • R Bazin
  • E Doublet
Bazin R, Doublet E. 8. Atlas du vieillissement cutan é, Volume 1: Population europ é enne. Paris: Med ' Com; 2007.
Evaluation du dispositif de radiofréquence tripolaire Regen™ en utilisant un modèle experimental de peau humaine
  • S Boisnic
Atlas du vieillissement cutané, 1: Population européenne. Paris: Med'Com
  • R Bazin
  • E Doublet