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Clinical Applications of Radiofrequency: Nonsurgical Skin Tightening (Thermage)
Abstract
Thermage is a nonsurgical treatment for sagging skin in the jowl, neck, and eyelids. Abdominal striae, loose upper arm skin and buttock sagging, and improvement of the appearance of cellulite have become amenable to the radiofrequency treatment. Radiofrequency passed through cooled epidermis allows for radiofrequency-induced thermal damage to the dermis and deep dermal collagen (fibrous septae). The remodeling of the collagen leads to clinically discernible improvement in the sagging skin and skin quality; the remodeling of deep dermal collagen (fibrous septae) allows modeling of contours and improvement of the cellulite appearance.
... [1][2][3][4][5][6][7][8] RF technology has steadily gained popularity since the early 2000s, with consecutive increases annually of 10% or more. 9,10 These gains encompass aesthetic surgery and numerous nonaesthetic applications (tissue electrodissection, cardiac catheter ablation, ophthalmic surgery, etc). 7 Through impedance of electromagnetic current, RF waves lead to differential heating across distinct tissue types, consistent with Ohm's law (energy = current 2 × impedance × time). ...
... 6,7,10,12,13 Heating the dermal tissue to 42°C has been shown to trigger a healing cascade that leads to stimulation of new collagen and elastin formation. 9,[14][15][16] In animal studies, after 10 minutes of exposure to temperatures of 39°C-43°C, the amount of collagen increased from an average of 9% before therapy to 25.9% after a 3-month follow-up period compared with no change in the untreated areas. 4,17 Clinical studies on RF-assisted liposuction have shown up to 25% area contraction at 6 months and 35%-40% area contraction achieved at 1 year. ...
... The controlled heating allows for immediate tightening of the collagen triple helix via breakdown of hydrogen bonds in the collagen, causing shrinkage of the normal collagen structure, as well as induction of the healing cascade, leading to neocollagenesis, elastin remodeling, and angiogenesis over the following 3-4 months. 9 In addition, using a parachute analogy, the application of heat tightens the overlying fibroseptal networks (strings) and serves to uniformly contract the overlying skin (parachute). Complications are minimized by internal and external temperature, and impedance probes to rapidly detect (10×/ms) the soft tissue environment and automatically turns off RF energy if beyond the preset safety parameters (Figs. 1, 2). ...
Nonexcisional facial skin tightening has long been an elusive goal in aesthetic surgery. The "treatment gap" includes cases who are not "severe" enough for excisions surgery but not "mild" enough for most traditional noninvasive aesthetic modalities. In this retrospective review, we present the largest evaluation to date of radiofrequency (RF) skin tightening technology combination including bipolar RF (FaceTite; InMode) and fractional bipolar RF (Fractora modified to Morpheus8; InMode).
Methods:
A multicenter retrospective study was conducted between January 2013 and December 2018 using a combination of bipolar RF and fractional bipolar RF for the treatment of facial aging. Data collection included demographic information, Baker Face/Neck Classification, amount of energy used, adverse events, and patient satisfaction. Four cadaver dissections were also conducted to correlate the underlying neuromuscular anatomy with RF treatment of the lower face and neck.
Results:
Two hundred forty-seven patients (234 women and 13 men) were included in the study. Average age was 55.1 years (SD, ±8), body mass index was 24.3 (±2.4), and 9% (23/247) of patients were active smokers at the time of treatment. Patients had an average Baker Face/Neck Classification score of 3.1 (SD, ±1.4). The procedure was performed under local anesthesia in 240/247 cases (97.2%). Patients objectively improved their Baker Face/Neck Classification score by 1.4 points (SD, ±1.1). Ninety-three percent of patients indicated that they were pleased with their results and would undergo the procedure again. Complications recorded for our cohort included prolonged swelling >6 weeks (4.8%, 12/247), hardened area >12 weeks (3.2%, 8/247), and marginal mandibular neuropraxia (1.2%, 3/247), which all resolved without further intervention. When considering possible control variables, age seems to be a significant factor. That is, older patients were more likely to benefit from a larger magnitude of the treatment effect (as demonstrated by a decrease in the Baker rating from pre- to posttreatment) when compared with younger patients. However, both groups did demonstrate significant improvements across time.
Conclusion:
While this combination RF treatment (FaceTite bipolar RF and fractional bipolar RF) does not aim to replace a facelift/necklift in appropriate candidates, it does broaden the plastic surgeons' armamentarium to potentially fill a treatment gap.
... The devices used for laxity treatment work producing heat in enough amount to warm up the dermis (DeHoratius and Dover 2007;Hodgkinson 2009). Beyond radiofrequency, ultrasonic waves and infrared radiation devices also act through dermal heating (DeHoratius and Dover 2007). ...
... When trying to move into the tissue, the resistance to the rotational movement of electrons generates high-frequency oscillation in the water molecules of the dermis (Goldberg et al. 2008). This energy oscillation is eventually transformed into thermal energy (Ohm's law) (Mulholland 2011;Hodgkinson 2009;Osório and Torezan 2009). The resistance to the passage of electrons depends on the tissue's characteristics, such as its temperature and the concentration of water (Abraham and Mashkevich 2007). ...
... The heating of dermal collagen between 50 and 70 C (Celsius degrees) results in the rupture of hydrogen bonds and in changes in the conformation of collagen fibers, which lose their threedimensional structure and assume an amorphous form, causing it to contract by 30 % and thickening the fiber (immediate tissue retraction) (Hodgkinson 2009;Bogle et al. 2007). The collagen contraction is a time-and temperaturedependent process, every 5 of temperature reduction, a 10 min increment is required to obtain the same amount of retraction (the Arrhenius equation) (Brightman et al. 2009). ...
... The devices used for laxity treatment work producing heat in enough amount to warm up the dermis (DeHoratius and Dover 2007;Hodgkinson 2009). Beyond radiofrequency, ultrasonic waves and infrared radiation devices also act through dermal heating (DeHoratius and Dover 2007). ...
... When trying to move into the tissue, the resistance to the rotational movement of electrons generates high-frequency oscillation in the water molecules of the dermis (Goldberg et al. 2008). This energy oscillation is eventually transformed into thermal energy (Ohm's law) (Mulholland 2011;Hodgkinson 2009;Osório and Torezan 2009). The resistance to the passage of electrons depends on the tissue's characteristics, such as its temperature and the concentration of water (Abraham and Mashkevich 2007). ...
... The heating of dermal collagen between 50 and 70 C (Celsius degrees) results in the rupture of hydrogen bonds and in changes in the conformation of collagen fibers, which lose their threedimensional structure and assume an amorphous form, causing it to contract by 30 % and thickening the fiber (immediate tissue retraction) (Hodgkinson 2009;Bogle et al. 2007). The collagen contraction is a time-and temperaturedependent process, every 5 of temperature reduction, a 10 min increment is required to obtain the same amount of retraction (the Arrhenius equation) (Brightman et al. 2009). ...
Over the last decades, non- or minimally invasive skin rejuvenation techniques have shown continuous and growing demand. Although surgical procedures are the “gold standard” for facial and body skin sagging treatment, many patients choose procedures with lower downtime, even if it means more subtle results, because they don’t want to be away from their work and social activities. In order to fulfill this need, a range of non-ablative devices was introduced, such as lasers, devices using light sources – as intense pulsed light (IPL) – and radiofrequency. This chapters discuss radiofrequency, an extremely valuable therapeutic for rejuvenation, as it allows patients to keep realizing their activities and also provides “natural” results.
... Many patients have considered filler treatment for this condition. In a previous study, patients who received filler reported no effect on nasal folding, whereas those that had the thermage treatment indicated a positive effect [23]. In this study, the patients who underwent thermage treatment had less nasolabial fold filler treatment. ...
... These same patients, in general, had good-quality skin despite early aging, and expressed that persons who do not want an operative procedure might be satisfied with thermage tissue tightening [23]. The present study found that patients who had received thermage treatment had received fewer treatments with thread lift (P < 0.001). ...
... Radiofrequency (RF) energy has a long history of use in sensitive tissues, such as mucosal tissue in the vagina, [21][22][23] cornea, [24][25][26] and skin. 27,28 The device used in the VIVEVE I trial delivers dual-mode, monopolar, radiofrequency energy with cryogen cooling to protect the superficial mucosa, while enabling heat to reach deeper into the underlying tissue layers. This dual-mode therapy uses heating and cooling to activate fibroblasts to produce new collagen and stimulate remodeling of vaginal tissue without evidence of fibrosis or underlying scarring, thereby providing additional support to the connective tissue matrix of the introitus and associated genitopelvic structures. ...
... This dual-mode therapy uses heating and cooling to activate fibroblasts to produce new collagen and stimulate remodeling of vaginal tissue without evidence of fibrosis or underlying scarring, thereby providing additional support to the connective tissue matrix of the introitus and associated genitopelvic structures. [21][22][23]27,[29][30][31][32][33][34][35][36][37] Preclinical studies of cryogen-cooled monopolar radiofrequency (CMRF) delivered to the vaginal introitus demonstrated nonfibrotic collagen deposition up to 6 months posttreatment. 30,31 Two single-arm, pilot studies in women with vaginal laxity showed CMRF therapy was safe and effective at 6 and 12 months postintervention. ...
Objective:
This subanalysis of the VIVEVE I trial aimed to evaluate the impact of cryogen-cooled monopolar radiofrequency (CMRF) therapy, for the treatment of vaginal laxity, on the domains of sexual function included in the Female Sexual Function Index (FSFI).
Materials and methods:
The VIVEVE I clinical trial was prospective, randomized, single-blind, and Sham-controlled. Nine clinical study centers in Canada, Italy, Spain, and Japan were included. This subanalysis included premenopausal women with self-reported vaginal laxity who had ≥1 term vaginal delivery and a baseline FSFI total score ≤26.5, indicating sexual dysfunction. Enrolled subjects were randomized (2:1) to receive CMRF therapy [Active (90 J/cm2) vs. Sham (≤1 J/cm2)] delivered to the vaginal tissue. Independent analyses were conducted for each FSFI domain to evaluate both the mean change, as well as the clinically important change for Active- versus Sham-treated subjects at 6 months post-intervention.
Results:
Subjects randomized to Active treatment (n = 73) had greater improvement than Sham subjects (n = 35) on all FSFI domains of sexual function at 6 months postintervention. The analysis of covariance change from baseline analyses showed statistically significant improvements, in favor of Active treatment, for sexual arousal (p = 0.004), lubrication (p = 0.04), and orgasm (p = 0.007). In addition, Active treatment was associated with clinically important and statistically significant improvements in sexual desire [Odds ratio (OR) = 3.01 (1.11-8.17)], arousal [OR = 2.73 (1.06-7.04)], and orgasm [OR = 2.58 (1.08-6.18)].
Conclusions:
This subanalysis showed CMRF therapy is associated with statistically significant and clinically important improvements in sexual function in women with vaginal laxity. These findings provide the first randomized, placebo-controlled energy-based device evidence for functional improvements associated with a nonsurgical modality for a highly prevalent and undertreated condition.
... The effectiveness of RF has also been confirmed by other researchers. [5][6][7][17][18][19][20][21][22] Effective treatments are carried out using unipolar, 22 bipolar, 17 tripolar, [18][19][20] or such where RF is combined with other therapies. 6,7,19 As reported in literature, treatment using RF improves skin appearance, is effective in modelling facial features and reducing cellulite. ...
... 6,7,19 As reported in literature, treatment using RF improves skin appearance, is effective in modelling facial features and reducing cellulite. [5][6][7][17][18][19][20][21][22][23] Unfortunately, literature lacks in-depth studies that monitor the course of the treatment with RF using classic and high-frequency ultrasound, despite the fact that this method is increasingly used in dermatology and cosmetic dermatology. 14,16 Typically, researchers use palpation and photographic techniques, while objective examinations usually include a histopathological examination. ...
Cellulite affects nearly 85% of the female population. Given the size of the phenomenon, we are continuously looking for effective ways to reduce cellulite. Reliable monitoring of anticellulite treatment remains a problem.
The main aim of the study was to evaluate the effectiveness of anticellulite treatment carried out using radiofrequency (RF), which was monitored by classical and high-frequency ultrasound.
Twenty-eight women underwent anticellulite treatment using RF, 17 women were in the placebo group. The therapy was monitored by classical and high-frequency ultrasound. The examinations evaluated the thickness of the epidermal echo, dermis thickness, dermis echogenicity, the length of the subcutaneous tissue bands growing into the dermis, the presence or absence of oedema, the thickness of subcutaneous tissue as well as thigh circumference and the stage of cellulite (according to the Nürnberger-Müller scale).
Cellulite was reduced in 89.286% of the women who underwent RF treatment. After the therapy, the following observations were made: a decrease in the thickness of the dermis and subcutaneous tissue, an increase in echogenicity reflecting on the increase in the number of collagen fibres, decreased subcutaneous tissue growing into bands in the dermis, and the reduction of oedema. In the placebo group, no statistically significant changes of the above parameters were observed.
Radiofrequency enables cellulite reduction. A crucial aspect is proper monitoring of the progress of such therapy, which ultrasound allows.
... Several treatments have been suggested to reduce the effects of aging, seeking to delay skin wear. For these dysfunctions, ablative procedures, such as lasers and radiofrequency 1,3 , are currently presented as non-invasive options for collagen remodeling, whereas collagen biostimulators, such as poly-l-lactic acid and calcium hydroxyapatite 4,5 , represent injectable treatments. Ablative or non-ablative resurfacing techniques improve the skin's surface but do not adequately lift the underlying ptotic tissues, which is crucial in achieving a more youthful appearance. ...
This study reports a case of abdominal flaccidity after three pregnancies in which smooth and spiculated polydioxanone threads were used, a technique not yet described in the literature to treat this complaint. The patient was followed up for 90 days. However, there was an improvement in the opening of the umbilical fold, skin tone, dermal density, and tissue flaccidity after 60 days. During this period, the patient declared that she was completely satisfied, and discharge from treatment was established. With this case report, we can conclude that the combined therapy of PDO thread screws and spiculated PDO threads (Sculpt®) resulted in very expressive outcomes regarding the quality of the skin, promoting a visible improvement in tissue flaccidity.
... While this technique may only be modestly effective for adipose reduction, RF has been clinically effective for skin laxity and rejuvenation in the face, limbs, abdomen, buttocks, and vulva [39,40,[44][45][46][47]. Given the positive results for skin tightening in the genital region along with the localized, moderate fat pad size in this region, suprapubic adipocity could theoretically be a target for RF. ...
Excess suprapubic adiposity can have negative consequences for patients, including concerns related to physical comfort, sexual function, hygiene, and esthetics. Historically, treatment options for pubic contouring have been limited to surgical methods. The purpose of this article is to review the literature investigating the use of minimally invasive fat reduction treatments for suprapubic adiposity including cryolipolysis, injection lipolysis, radiofrequency, and ultrasound. A thorough search of the PubMed database was conducted to search for studies evaluating the use of cryolipolysis, injection lipolysis, radiofrequency, and ultrasound for suprapubic adiposity. The literature search did not yield any publications that evaluated the use of cryolipolysis, injection lipolysis, radiofrequency, or ultrasound for treatment of suprapubic adiposity. Minimally invasive treatments for fat reduction, including cryolipolysis, injection lipolysis, radiofrequency, and ultrasound, have clinically demonstrated safety and efficacy in various anatomic locations. However, clinical studies evaluating these procedures for suprapubic adiposity are noticeably absent. These options may confer benefits such as decreased recovery time, risk, and cost to patients. Future clinical studies evaluating these potential treatment modalities for suprapubic fat reduction are warranted.
... 9 Since the inception of the first commercially available RF device in 2004 (ThermaCool Thermage, Inc., Hayward, CA), RF devices have only continued to improve in efficacy, consistency, and safety. 10 Consistent results coupled with little to no pain, no downtime, and few side effects have catapulted RF devices to the forefront of the noninvasive skin tightening options. The main drawback of this original device, however, is the operator-dependent nature of the treatment and the fact that treatments are time-intensive, leading to operator fatigue. ...
Background:
Aging is a multifactorial response to genetic preprogramming nuances, sun exposure, and ultraviolet radiation. Recently, there has been a paradigm shift toward minimally invasive rejuvenation.
Objective:
This prospective multicenter study aims to evaluate the efficacy and safety of a novel hands-free bipolar bulk radiofrequency (RF) device in terms of improvement in skin appearance.
Patients and methods:
This multicenter prospective study enrolled subjects aged 35 to 75 years with visible signs of aging. The primary objective was to evaluate skin appearance pretreatment and at 1, 3, and 6 months after the final treatment. Each patient received 3 total treatments to the chin and cheeks using the hands-free RF device spaced 2 weeks apart.
Results:
In total, data from 87 patients were assessed from 6 treatment sites. The average age was 54 years (range 35-75 years). Most patients were female (97%), and Fitzpatrick skin types I to V were represented. Overall, patients found the procedures to be relatively pain-free, and both patients and investigators felt they noted some improvement in their skin appearance. Histological sections demonstrated an increase in collagen or elastic fibers within the papillary dermis.
Conclusion:
This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.
... 32 Today's aesthetic RF devices have advanced significantly over the first FDA approved RF device for facial wrinkle reduction in 2004 (ThermaCool, Thermage, Inc., Hayward, Calif.). 33 The major advance has not only been in the RF energy delivery method itself but in depth, control, and consistency of energy delivery. The balance between temperatures that trigger a nonablative wound healing response to remodel collagen as opposed to ablating collagen is relatively narrow. ...
Background:. The use of radiofrequency in aesthetic surgery has evolved significantly since it was first introduced in the early 2000s. Nonexcisional correction of the lower one-third of the face and neck has long been a challenging problem. The purpose of this prospective study was to assess the safety and efficacy of the first handsfree thermoregulated bipolar radiofrequency device for face and neck contouring.
Methods:. This prospective multicenter (New York, Nevada) IRB-approved study evaluated healthy candidates who desired noninvasive correction of their lower face and neck laxity. The primary objective of this study was to evaluate safety and soft tissue remodeling pretreatment and at 1-, 3-, and 6-months post last treatment. Assessment was made using blinded evaluators, 3D photographic analysis (Quantificare, France), and volumetric measurements. Investigator and subject assessments were obtained using a 0-4 point Likert scale.
Results:. A total of 34 patients completed both the cheek and chin applicator treatment series. Average age of patients was 38 (STD 3.4), BMI 27 (STD 2.2), average Baker Face & Neck classification 2.6 (STD 1.1), and average Fitzpatrick type 2.4 (STD 1.2). Mean treatment time was 41 min (STD 3.5) with a temperature of 42°C–43°C. Patient discomfort data were statistically very low based on t-test analysis. Satisfaction metrics measured at 1- and 3-month follow-up demonstrated a significant change in subject skin appearance, subject overall satisfaction, and investigator improvement perception. More patients were satisfied at the 3-month follow-up compared with the 1-month follow-up for all three measures. Volumetric data demonstrated an average change of −3.2 cm3 (STD ±1.2 cm3) per side for the cheek applicator and −4.1 (STD ±2.3) for the submental applicator. Of note there were cases where volume increases were noted that were believed to be related to soft tissue contraction.
Conclusions:. This is the first prospective study to evaluate a handsfree thermoregulated bipolar radiofrequency device for face and neck contouring. This device demonstrates a significant advance in the control and delivery of radiofrequency for aesthetic purposes. With a favorable safety and comfort profile, this device is able to concentrate thermal energy consistently at a depth that allows for fibroseptal network tightening to improve lower third of face and submental soft tissue contraction.
... [13][14][15] Other energy-based treatments, including radiofrequency or deep-focused ultrasound, can address skin quality temporarily, but can be costly and are not widely available. [16][17][18][19] Despite arm contouring, skin quality often remains an aesthetic concern. ...
Background
Skin aging of upper arm, induced by intrinsic and extrinsic factors, often results in loss of contour, elasticity and firmness, and increase in laxity, crepiness, roughness and photodamage. A topical body firming moisturizer (TBFM) was developed to target all aspects of aged body skin.
Objective
The aim of this study was to evaluate the efficacy and tolerability of the TBFM for upper arm firming and rejuvenation.
Methods
Forty female subjects, 40-60 years old, Fitzpatrick skin type II-V, with mild to moderate laxity, crepiness, and photodamage on the upper arms were recruited into the study, 10 of whom were selected for biopsy analysis. Subjects were randomized to apply the TBFM and placebo moisturizer on the assigned arms twice daily for 12 weeks. At each visit, efficacy and tolerability evaluation, self-assessment, and standardized clinical photography were taken. Ultrasound measurements were performed at baseline, week 8 and week 12.
Results
Results from the efficacy evaluation by the clinical grader and bio-instrumentation analysis showed the TBFM improved all skin parameters of the aged upper arm while outperforming the placebo moisturizer after 12 weeks. Clinical photography showed the test product was able to tone and firm the skin. The TBFM was well-tolerated and well-perceived by the subjects. Ultrasound images illustrated an improvement in skin density and skin structure at week 12.
Conclusion
This clinical trial positively supports the hypothesis that the TBFM was effective and tolerable in improving crepey, lax, and photodamaged skin of the upper arms after 12 weeks of treatment twice daily.
... Orgasmic dysfunction, like anorgasmia or increased time to achieve orgasm is one of the associated symptom [13]. RF energy has a long history of use in mucosal tissue in the vagina and skin [14][15][16][17][18]. By creating heat via impedance as electric current is conducted through vaginal tissue, stimulation of fibroblasts occurs, and the therapeutic outcome is achieved [19]. ...
... Referenzen zur Hochfrequenz-Stimulation (für ausgewählte Literatur zu einzelnen Anwendungen siehe Anhang in 12.6.2): (Alizadeh, Halabchi et al. 2016), (De Felipe, Del Cueto et al. 2007), (Gold, Pozner et al. 2016), (Gold, Biesman et al. 2017), (Hodgkinson 2009), (Kennedy, Verne et al. 2015), (Pritzker, Hamilton et al. 2014), (Sekaran and Carachi 2013), , (Suh, Byun et al. 2017), (Sukal and Geronemus 2008), (Yu, Yeung et al. 2007 Referenzen zur Stimulation mit Plasma (für ausgewählte Literatur zu einzelnen Anwendungen siehe Anhang in 12.6.2): (Alkawareek, Gorman et al. 2014), (Babington, Rajjoub et al. 2015), (Bekeschus, Schmidt et al. 2018), (Bogle, Arndt et al. 2007), (Emmert, Brehmer et al. 2013), (Fridman, Peddinghaus et al. 2006), (Heinlin, Morfill et al. 2010), (Hirst, Frame et al. 2014), (Hoffmann, Berganza et al. 2013), (Karrer and Arndt 2015), (Kisch, Schleusser et al. 2016), (Koeritzer 2013), (Kramer, Dissemond et al. 2018), (Kuchenbecker, Bibinov et al. 2009), (Lademann, Ulrich et al. 2013), (Langmuir 1928), (Lehmann, Pietag et al. 2017), (Lin and Keidar 2016), (Mann, Tiede et al. 2016), (Metelmann, Seebauer et al. 2018), , (Mitra, Morfill et al. 2012), (Reuter, Masur et al. 2014), , (Wende, Bekeschus et al. 2016 ...
Das Vorhaben wurde mit Mitteln des Bundesministeriums für Umwelt, Naturschutz und nukleare Sicherheit (BMU) und im Auftrag des Bundesamtes für Strahlenschutz (BfS) durchgeführt.
... These devices deliver heat to the dermis and subcutaneous tissues, with collagen denaturation, increased fibroblast activity, and new collagen formation resulting in skin tightening over weeks to months [5]. Skin laxity can be decreased and skin contour improved on both the face and the body [6][7][8][9]. ...
Non-invasive skin-tightening devices can induce thermal denaturation and skin shrinkage via externally applied radiofrequency emissions or high-frequency ultrasound. Therefore, the purpose of this study is to develop and test a method for measurement of skin reduction associated with application of such energy devices. Twenty-five healthy participants with mild to moderate skin laxity of the arms were enrolled. Pinpoint microtattoos were placed at each of the treatment sites to delineate two 6 × 12 cm rectangles per subject. A non-stretchable filament, tape and marking pen apparatus was used to measure the size of each rectangle before treatment and at follow-up visit by two blinded investigators. After randomization, one side received a single pass with a radiofrequency device (6.78 MHz), while the contralateral side received multiple passes. Participants underwent two treatment sessions to each side 2 weeks apart, and returned for follow-up 4 weeks after the second treatment. Length and area measurement were analyzed to assess precision and accuracy of measurements and to compare efficacy of treatment between pre- and post-treatment. Concordance correlation coefficients (CCC) demonstrated substantial inter-investigator reliability and precision in length measurements (CCC, 0.94 to 0.98 in pre-treatment; 0.95 to 0.98 in post-treatment). Measurements at the 6-week post-treatment follow-up demonstrated a statistically significant skin reduction in all six of the measured parameters. A simple skin measurement method requiring minimal instrumentation can quantitatively evaluate skin shrinkage associated with non-invasive skin-tightening devices.
... The depth of heating depends on the tip size and geometry. The efficacy of the Thermage® has been reported in a variety of studies [22][23][24]. It was developed as a noninvasive modality so patients could experience easy access to treatment. ...
As demand for a youthful appearance has increased, various techniques for face lifting and contouring have been used to reduce excess fat deposition and improve skin laxity. Recently, radiofrequency (RF)-assisted lipolysis and liposuction (RFAL) has been introduced for body and face contouring. This study aimed to evaluate the clinical improvement and safety of a new RFAL device for face lifting and contouring. A prospective study was conducted in 20 Korean patients who underwent an internal real-time thermosensing monopolar RFAL procedure. Prior to treatment and 12 and 24 weeks after treatment, digital photographs were taken, and the degree of improvement as measured by investigators and patients was recorded. Skin elasticity was measured using a Cutometer (CT575, Courage and Khazaka®, Cologne, Germany). Safety profiles were also evaluated at each visit. Results showed favorable improvement in skin laxity and fat deposition. Both investigators’ evaluations and patients’ evaluation showed significant improvement between 12 and 24 weeks. Although the changes in skin elasticity measured by the Cutometer were not statistically significant, all three treated regions showed a trend toward improvement. No major side effects such as infection or burn were observed. The internal, real-time thermosensing monopolar RFAL device showed clinical efficacy and safety. After further studies with more patients and longer follow-up periods, internal real-time thermosensing monopolar RF devices might become one of the popular treatment options for face lifting and contouring.
... Acontece com as moléculas eletricamente neutras, que não tem movimento porque não tem carga elétrica, entretanto, os elétrons que rodeiam o núcleo são atraídos sofrendo uma distorção das suas órbitas. (20,26,27) O efeito térmico produzido pela RF provoca uma desnaturação do colágeno promovendo uma contração imediata e efetiva das suas fibras, causando um processo inflamatório local e agudo, ativando os fibroblastos e, consequentemente, gerando uma neocolagenização e também proporciona uma reorgaização das fibras de colágeno. (26) ...
A incontinência urinária de esforço(IUE) é definida como a queixa de perda urinária involuntária no esforço segundo o Consenso da Sociedade Internacional de Continência (International Continene Society - ICS). Ela chega a atingir 50% da população adulta feminina. Um dos mecanismos responsáveis por esse sintoma consiste na diminuição do colágeno nas paredes da uretra. A radiofrequência pode ser utilizada com o objetivo de promover a produção de colágeno. Assim a literatura tem colocado tanto o uso da radiofrequência ablativa vaginal como a não ablativa por via intra-uretral como possibilidades terapêuticas satisfatórias. A radiofrequência intra-uretral é uma técnica não ablativa porém desconfortável, de custo elevado principalmente pela necessidade de anestesia e de uso de antibiótico profilaxia, por ser aplicada dentro do canal uretral. No presente artigo serão descritas as teorias sobre a IUE, discutir sobre a radiofrequência aplicada com a finalidade terapêutica intra-uretral e fornecer uma perspectiva para a evolução da aplicação via vaginal, considerando que esta via aparece como uma alternativa menos invasiva e de baixo custo para o tratamento da IUE.
... With the "non-ablative" approach to skin enhancement, multiple treatments were usually required and results were generally less dramatic than ablative therapies. Clinical data suggests that RF based devices provide stronger tightening effect [15][16][17][18], through the ability to penetrate more deeply into the sub-dermal space, while laser penetration depth is limited by the dermis. ...
This paper reports the clinical experience of a multi-center, multiple physician trial with a novel fractional radiofrequency ablative skin resurfacing and rejuvenation device (Fractora, Invasix, Israel) deployed on both Caucasian skin types I - III and Asian skin type IV. Histological study demonstrated deep ablation and collagen restructuring in the papillary and reticular dermis. The Fractora device combines the more “cone shaped” ablation seen with CO2 and Erbium lasers with a deep non-ablative heating pattern, seen with other bipolar RF fractional needle resurfacing devices. Ablation, coagulation zones and healing dynamics are analyzed for different energy settings. Two different treatment protocols are suggested: one for light skin and then one for darker skin with a higher risk of post-inflammatory hypperpigmentation. Treatment results show improvement in skin texture, pores, wrinkles and skin dyschromia.
... This makes radio frequency suitable for the treatment of body circumference reduction, sagging skin, and cellulite. 30,31 Radio frequency may be monopolar (two separate electrodes): bipolar or unipolar. Monopolar systems are associated with more pain but are more penetrating in contrast to S a n L u c a s M e d i c a l , L L C bipolar systems. ...
... For example, low-dose RF energy is used to clinically tighten skin, and much of our current understanding derives its basis from this application. [1][2][3][4][5][6][7] A theme common to these devices is the carefully controlled application of "nonablative" RF energy levels to subtly change collagen and promote tissue renewal. Therefore, achieving the desired clinical outcome requires delivering a thermal dose which is adequate to stimulate tissue rejuvenation yet insufficient to cause cellular necrosis with subsequent scarring. ...
Novel non-ablative hyperthermic medical devices are currently being developed, in association with cryogen surface cooling, to rejuvenate tissues without collagen scarring. These devices have been designed to remodel skin, manage urinary stress incontinence, and more recently, treat vaginal laxity. In contrast to the thermal injury and reparative healing associated with higher energy ablation systems, these lower energy non-ablative systems are designed to subtly modify the collagen, stimulate the fibroblasts, and maintain a functional tissue architecture that subsequently promotes tissue rejuvenation and restoration. While these devices have primarily relied on clinical outcome questionnaires and satisfaction surveys to establish efficacy, a physiologic explanation for the induced tissue changes and tightening has not been well documented. Recent histology studies, using the Viveve ovine vaginal treatment model, have identified changes that propose both a mechanism of action and a tissue remodeling timeline for such non-ablative hyperthermic devices. The Viveve model results are consistent with subtle connective tissue changes leading to fibroblast stimulation and subsequent collagen replacement and augmentation. Unlike tissue ablation devices that cause thermal necrosis, these non-ablative devices renew the targeted tissue without dense collagenous scarring over a period of 3 or more months. The spectrum of histologic findings, as illustrated in the Viveve ovine vaginal model, further support the previously documented safety and efficacy profiles for low-dose non-ablative hyperthermic devices that rejuvenate and tighten submucosal tissues.
Skin and subcutaneous tissue tightening is usually treated by noninvasive photothermal treatment for medical aesthetics purpose, while the underlying mechanism remains to be elucidated. Here we hypothesized that adipocyte injury, as a stimulator, may regulate ECM production by increasing ALOX15 in macrophages, which could lead to fibroblast activation. In this study, we show that lipolysis was induced by laser heating (45°C for 15 minutes) in patients and rats, and adipocyte thermal injury stimulates the ECM production in fibroblasts by ALOX15 that was increased in co‐cultured macrophages. These phenomena were evidenced by the ALOX15 knockdown. In addition, ALOX15 metabolite 12(S)‐HETE activated p38 MAPK signaling pathway that mediated the production of ECM in fibroblast. In summary, the results of this study demonstrate that the mechanisms of adipose photothermal injury‐induced skin and/or subcutaneous tissue tightening may have clinical relevance for noninvasive or minimally invasive photothermal therapeutics. This article is protected by copyright. All rights reserved.
Nowadays more and more people pay attention to the medical cosmetology industry. This paper presents a study of thermage robot system. In the first, a thermage robot system via hardware design and software design was built. Then, hand-eye calibration, visual recognition and localization, constant force control algorithm were applied to the system. Finally, the experiments based on facial model and human face were carried out, and the feasibility of the proposed thermage robot system was validated effectively.
Background:
Radiofrequency (RF) treatment is a relatively new and increasingly popular option for patients desiring skin tightening and an improvement in facial or body contour without undergoing an excisional surgical procedure. A systematic review of the literature was performed to investigate the safety and efficacy of monopolar and bipolar radiofrequency devices for facial and body rejuvenation.
Methods:
A computerized search of the MEDLINE database was performed for clinical studies investigating the use of monopolar and bipolar radiofrequency devices in facial and body rejuvenation. Data on the type of device, treated areas, number of patients, number of treatments, follow-up, complications, and outcomes was collected.
Results:
The systematic review was performed in September 2020. A total of 207 articles examined the use of radiofrequency technology for cosmetic purposes, and 23 articles remained after all inclusion and exclusion criteria were considered. Nine articles evaluated monopolar devices and five articles evaluated bipolar devices for treatment of the face. Three articles evaluated monopolar devices and six articles evaluated bipolar devices for treatment of various body areas.
Conclusion:
There is clinical evidence that monopolar and bipolar radiofrequency devices produce measurable improvement in skin laxity of the face and body with an acceptable complication profile. Although the vast majority of reported complications are minor and transient in nature, major complication rates are higher with the use of monopolar devices than with the use of bipolar devices.
Background:
Cellulite is an aesthetic condition affecting the appearance of skin in specific body regions. When reviewing past literature, a 2-D image of a subdermal septum was created most likely due to the applied cross-sectional investigative methodology. Despite practitioners are aware of the 3-D nature of the subdermal architecture, this is not reflected in the present scientific literature. The aim of this anatomic review is to summarize the past literature and to provide an update on the 3-dimensionality of a subdermal septum with specific focus on the pathophysiology of cellulite.
Materials and methods:
This review is based on the literature search performed in the PubMed database using the keywords: cellulite (n = 777), cellulite AND pathophysiology (n = 53). The articles obtained were screened and those focusing on "cellulitis" or other non-cellulite related topics were additionally excluded resulting in a total of n = 38 relevant articles which were evaluated for the purpose of this anatomic review.
Results:
The skin is comprised of two fat layers (superficial and deep), separated by the superficial fascia. The dynamic 3-D interplay between retinacula cutis, fascia, and fat, with anatomic differences between men and women, highlights a complex anatomic construct with direct implications for the formation and treatment of cellulite.
Conclusion:
The 3-dimensionality of a subdermal septum provides important clinical clues to understanding the underlying mechanisms and pathogenesis of cellulite. The 3-D approach, in contrast to the past 2-D models, presents a robust foundation for understanding and developing future cellulite therapeutic strategies.
Background:
Submental skin laxity becomes a common cosmetic problem with age. Bipolar radiofrequency is a new, non-invasive procedure. Unlike the LASER, the radiofrequency (RF) device has no specific chromophore absorption. Thus, the device can be used on any skin type.
Objective:
To evaluate the effectiveness and adverse effects of the bipolar RF for treatment of submental laxity and skin tightening.
Material and methods:
Twenty-two patients with submental laxity were treated with FormaTM on both sides of the submental area. The patients underwent four sessions every two weeks for one and half months. Two blinded dermatologists evaluated the pre-treatment and post-treatment photographs every visit. The three-dimensional photographs were recorded by Vectra® camera and determined the association.
Results:
All 22 patients completed all the treatment sessions. The degree of improvement was statically significant after the third session based on the physical assessment scale and after the second session in terms of the submental laxity score. The fat volume reduction was statically significant from one week to six months from baseline. Almost all subjects developed transient erythema immediately after the treatment. No serious side effects were noted.
Conclusions:
The bipolar RF device is another potential choice for skin tightening due to its efficacy and safety profile. It can be used with any skin type and has few side effects.
Non‐invasive body contouring is a rapidly growing field in cosmetic dermatology. Non‐invasive contouring devices improve the body's appearance through the removal of excess adipose tissue, particularly in areas in which fat persists despite optimal diet and exercise routine. The technology can also be used for skin tightening. This article reviews the five FDA‐approved non‐invasive body contouring modalities: cryolipolysis, laser, high‐intensity focused electromagnetic field, radiofrequency and high‐intensity focused ultrasound. These devices have emerged as a popular alternative to surgical body contouring due to their efficacy, favourable safety profile, minimal recovery time and reduced cost. Although they do not achieve the same results as liposuction, they are an attractive alternative for patients who do not want the risks or costs associated with surgery. When used appropriately and correctly, these devices have demonstrated excellent clinical efficacy and safety.
Noninvasive methods have become increasingly popular, and there is significant demand for effective, proven methods of nonablative skin rejuvenation. Nonablative capacitive radiofrequency has been a successful and well-received approach for nonsurgical skin tightening. Radiofrequency (RF) energy is electromagnetic radiation in the range of 3–300 GHz. Thermage systems utilize the company’s proprietary technology, incorporating large monopolar capacitive electrodes to deliver RF energy into the skin while concurrently protecting the skin surface with a cryogen cooling spray. Indications, treatment considerations, technique, results, and complications are discussed.
Most aesthetic practitioners combine treatments to achieve the best results for their patients. Since botulinum toxin (BoNT) is the most commonly performed aesthetic treatment, it stands to reason that it would also be the most commonly combined with other treatments. Many investigators have attempted to understand and quantify the benefits of combining therapies. This chapter presents the data on these combinations and aims to put them into clinical perspective. Shaping of the brow is another area particularly well suited for combination therapy with BoNT and filler. Another application of BoNT and filler combination is reshaping of the nasal dorsum and tip. The contour of the nasal tip can be affected by loss of volume as well as surgical depression or previous injury. Injection of filler at the base of the columella can elevate the nasal tip. Muscle stimulation enhances facial appearance through the increased volume that the "hypertrophied" facial elevator muscles occupy.
Introduction:
Vaginal laxity is a highly prevalent and undertreated medical condition.
Aim:
To evaluate the efficacy and safety of surface-cooled, monopolar radiofrequency (RFc) therapy for the treatment of vaginal laxity in the VIVEVE I trial.
Methods:
The VIVEVE I trial was a prospective, randomized, single-blinded, and sham-controlled study. Nine study centers in Canada, Italy, Spain, and Japan participated. Women presenting with vaginal laxity were screened and informed consent was obtained. Major study inclusion criteria were premenopausal status, age at least 18 years, at least one full-term vaginal delivery, and normal genito-pelvic examination results. Enrolled subjects were randomized (2:1) to receive RFc therapy (Active [90 J/cm(2)] vs Sham [1 J/cm(2)], respectively) delivered to the vaginal tissue.
Main outcome measures:
The primary efficacy outcome was the proportion of randomized subjects reporting "no vaginal laxity" (Active vs Sham) at 6 months postintervention, which was assessed using the Vaginal Laxity Questionnaire. Treatment-emergent adverse events were evaluated in all treated subjects. Secondary efficacy end points included change on the Female Sexual Function Index (FSFI) and the revised Female Sexual Distress Scale (FSDS-R).
Results:
No vaginal laxity was achieved by 43.5% and 19.6% (P = .002) in the Active and Sham groups, respectively. Differences in FSFI and FSDS-R total scores (Active vs Sham) were 1.8 (P = .031) and -2.42 (P = .056), respectively, in favor of Active treatment. Treatment-emergent adverse events were reported by 11.1% and 12.3% of subjects in the Active and Sham arms, respectively.
Conclusion:
The VIVEVE I trial is the first randomized, controlled, blinded, clinical study of RFc for the treatment of vaginal laxity. A single treatment of RFc therapy was found to be safe and associated with both improved vaginal laxity and improved sexual function. The results from this trial support the use of a novel non-surgical therapy for vaginal laxity, a prevalent and undertreated condition.
Body contouring procedures of the trunk and abdomen have historically been among the top five surgical cosmetic procedures performed in the United States [1]. These conventional treatments for body contouring are the gold standard for patients interested in surgically improving or correcting contour abnormalities [2]. These procedures, while effective, are associated with the standard risks of any surgical procedure (e.g., the risks of general anesthesia, infection, wound healing complications) and the prerequisite recovery time. Recently, there has been a trend toward minimally invasive cosmetic procedures. While the total number of cosmetic surgical procedures has gone down over the past 8 years, the number of minimally invasive cosmetic procedures has nearly doubled during that same period of time to over ten million procedures in 2008 [1].
Radiofrequency energy has a wide range of medical applications, including noninvasive treatment of wrinkles and body contouring. This technology works by differential heating of skin and soft tissue layers causing dermal remodeling or adipolysis, ultimately leading to observable effects. This article reviews the physics of radiofrequency as applied clinically.
Background:
Aging, childbearing, and hormonal changes can lead to vulvovaginal laxity and mucosal atrophy that negatively affect a woman's quality of life. As more minimally and noninvasive options for genital rejuvenation become available in the outpatient setting, it becomes increasingly important for the dermatologic surgeon to be familiar with these popular procedures.
Objective:
To familiarize dermatologists with the nonsurgical options available for female genital rejuvenation, patient motivations for pursuing these procedures, relevant anatomy, and potential adverse events.
Materials and methods:
A MEDLINE search was performed on nonsurgical female genital rejuvenation from 1989 to 2015, and results are summarized.
Results:
Reports of nonsurgical female genital rejuvenation procedures using fractional carbon dioxide lasers, nonablative lasers, monopolar radiofrequency devices, hyaluronic acid fillers, and fat transfer are concisely summarized for the practicing dermatologist.
Conclusion:
Review of the literature revealed expanding options for nonsurgical female genital rejuvenation.
Background:
The aging arm is characterized by increased dyspigmentation, a proliferation of ectactic blood vessels, excessive adiposity, excessive skin laxity, and actinic keratosis. A variety of laser, energy, and surgical techniques can be used to improve these features.
Objective:
The objective of this article is to describe the treatment modalities that have proven efficacious in rejuvenating the aging arm and combination therapies that have the potential to optimize patient outcomes while maintaining safety and tolerability.
Methods:
A Medline search was performed on nonsurgical aesthetic combination treatments because it relates to arm rejuvenation, and results are summarized. Practical applications for these combination treatments are also discussed.
Results:
Although there is significant evidence supporting the effective use of nonsurgical treatments for arm rejuvenation, little in the literature was found on the safety and efficacy of combining such procedures and devices. However, in the authors' clinical experience, combining arm rejuvenation techniques can be done safely and often result in optimal outcomes.
Conclusion:
Arm rejuvenation can be safely and effectively achieved with combination nonsurgical aesthetic treatments.
Non-surgical facelift procedures improve hyperdynamic and static wrinkles, volume loss, and skin surface imperfections but do not address ptosis of deeper tissues including the malar fat pad and the superficial musculoaponeurotic system (SMAS). Although an open facelift remains the gold standard for sagging skin, fat, and the SMAS in older patients, less invasive measures using various suture systems and designs provide a novel alternative for younger patients with early signs of aging. The concepts of suture facelift and patient selection are discussed, as well techniques with a variety of sutures. Suture facelift techniques offer a quick, safe, and effective rejuvenation by elevating soft tissues and restoring the youthful contours of the face and neck.
Biostimulation with rich plasma in platelets is an outpatient technique for the prevention and management of skin aging, which is based on the physiology of the skin, and works very well alone or in a combined treatment plan. Own patient derivate blood stimulates production of collagen, elastin and skin tissue, resulting in a smoother skin, brighter and better quality. Risks of bruising, infection, disease transmission or allergic reactions are minimal.
With the increased popularity of minimally invasive cosmetic treatments, this study evaluates the efficacy and safety of microfocused ultrasound with visualization (MFU-V) for tightening lax skin above the elbow.
Subjects were treated bilaterally above the elbows with MFU-V using transducers with different focal depths. Photographs were taken before treatment and at 90- and 180-day follow-ups. Masked observer ratings and physician and subject global aesthetic improvement scales (PGAIS and SGAIS) were completed at follow-ups. Safety, based on adverse event (AE) incidence, was assessed.
Masked blinded assessment was completed at 90 days; 56% showed aesthetic improvement. Overall improvement in SGAIS was 83% and 81% at 90 and 180 days, respectively. The overall improvement in PGAIS was 94% at both 90 and 180 days. Patient satisfaction questionnaires showed that 83% noticed improvements in elbow characteristics at 90 days, with 81% still indicating improvement at 180 days. No serious AEs or treatment-related AEs were reported.
This pilot study suggests that MFU-V is a safe and promising nonsurgical option for the treatment of skin laxity above the elbow. Based on the positive results of this study, a larger trial is warranted together with testing different treatment densities to optimize this noninvasive approach.
La bioestimulación con plasma rico en plaquetas es una técnica ambulatoria para la prevención y manejo del envejecimiento cutáneo, se basa en la fisiología de la piel y funciona muy bien sola o dentro de un plan terapéutico combinado. El derivado de sangre autóloga estimula la producción de colágeno, elastina y tejido epidérmico, lo que se traduce en piel más tersa, luminosa y de mejor calidad. Son mínimos los riesgos de formación de hematomas, infección, transmisión de enfermedades o reacciones alérgicas.
Building upon the fractional CO<SUB>2</SUB> technology incorporated into the first generation SmartXide DOT (DEKA / ElEn, SpA, Calenzano, Italy) introduced in the U.S. in 2008, a second generation SmartXide Quadro has recently been introduced. This is a versatile device that has the ability to combine fractional CO<SUB>2</SUB> laser output for skin resurfacing with the synchronous delivery of bipolar radiofrequency (RF) energy for deeper, more diffuse heating. A pilot study was undertaken to demonstrate the safety and efficacy of the SmartXide Quadro, employing both fractional CO<SUB>2</SUB> laser output combined with the synchronous delivery of radiofrequency energy for the treatment of facial rhytides and acne scars. Ten patients, all women, six with facial rhytides and four with acne scarring, were treated with the SmartXide Quadro, a variably pulsed CO<SUB>2</SUB> laser with Pulse Shape Design® technology, a microablative DOT scanner and synchronized bipolar RF emission. Each patient was treated with a single fractional CO<SUB>2</SUB> laser-RF treatment; laser and RF parameters varied according to the severity of the rhytides or acne scars and were based upon both manufacturer-recommended settings and surgeon experience. Follow-up was at three days, one week, 2 weeks, and one month, three months, and six months after treatment. Results were judged by comparison of preoperative and post-operative photos evaluated by independent physicians, preoperative and post-operative grading by treating physicians, subjective evaluation of results by the patients themselves, and tabulation and categorization of adverse events (AEs). The SmartXide Quadro variably pulsed CO<SUB>2</SUB> laser with a microablative DOT scanner, with synchronous delivery of bipolar RF energy emission, proved to be both safe and effective in the treatment of facial rhytides and acne scars. The single treatment protocol was well tolerated and recovery was similar to fractional CO<SUB>2</SUB> laser skin resurfacing alone. The AEs were minimal and no significant complications occurred.
J Drugs Dermatol. 2014;13(3):299-304.
Energy-based noninvasive surgical tools can be used for ablative bio-stimulation (eg, collagen production) or tissue restructuring functions (eg, tightening or lifting) and are the subject of this review. The authors present the various methods and tools for noninvasive cosmetic surgery (ultrasound, radiofrequency, cryolipolysis, and lasers) and present the clinical outcomes of each. They summarize techniques and methods and their indications, physical parameters and tissue target, and consistency.
Noninvasive methods have become increasingly popular and there is significant demand for effective, proven methods of nonablative
skin rejuvenation. Nonablative capacitive radiofrequency (RF) has been a successful and well-received approach for nonsurgical
skin tightening. RF energy is electromagnetic radiation in the range of 3–300 GHz.
Thermage systems utilize the company’s proprietary technology incorporating large mono-polar capacitive electrodes to deliver
RF energy into the skin while concurrently protecting the skin surface with a cryogen cooling spray. Indications, treatment
considerations, technique, results, and complications are discussed.
Nonsurgical procedures improve hyperdynamic and static wrinkles, volume loss, and skin surface imperfections but do not address
ptosis of deeper tissues including the malar fat pad and the superficial musculoaponeurotic system (SMAS). Although an open
facelift remains the gold standard for sagging skin, fat, and the SMAS in older patients, less invasive measures using various
suture systems and designs provide a novel alternative for younger patients with early signs of aging. The concepts of suture
facelift and patient selection are discussed as well techniques with a variety of sutures. Suture facelift techniques offer
a quick, safe, and effective rejuvenation by elevating soft tissues and restoring the youthful contours of the face and neck.
Suture facelift techniques currently provide a “better alternative” to nonsurgical tissue-tightening devices and injectable
procedures for patients who would benefit from lifting of mild to moderate ptosis, but they do not replace open facelift procedures
for those with more severe ptosis or excessive skin laxity. The rationale for treatment using suture lifts is to reverse the
early signs of aging by lifting and suspending tissues that have begun to drop. Suture types and techniques including barbed
sutures, nonbarbed sutures, and cone sutures are described.
There are several classification schemes, including that of the authors’, which one can use to categorize a patient’s neck
for surgical rejuvenation. This chapter describes facial anatomy, and discusses liposuction techniques with patient assessment,
tumescent anesthesia, and critical points for successful liposuction. Chin implantation, submentoplasty, and dealing with
the visible submandibular gland are also covered and the complications discussed. While rhytidectomy has traditionally been
the cornerstone technique that has been used to achieve this goal, there are many cases where submentoplasty or liposuction
is appropriate as stand-alone procedures. When used in the appropriate patient they are truly minimally invasive and yet can
provide spectacular results with minimal downtime.
To evaluate the safety and efficacy of a bipolar fractionated radiofrequency device for the improvement skin texture, fine lines and wrinkles in the treatment of skin types V through VI.
Fifteen subjects, skin types V and VI, between the ages of 40 and 64 were enrolled. Each received three treatments to the full face with fractionated bipolar RF device (Syneron Inc., Irvine, USA) spaced 30 days apart. Patients were evaluated by the study investigator and a blinded investigator at each treatment and 90 days after the last treatment for the treatment safety and efficacy.
A statistically significant improvement in wrinkles, texture and fine lines was noticed in most subjects. Any adverse events in particular post inflammatory hyperpigmentation or hypopigmentation were not seen in any of the patients.
Our study suggests that the use of this fractionated radiofrequency device is a safe and effective method of skin rejuvenation for skin types V through VI.
Upper arm skin laxity is an important area of cosmetic concern. Recent studies using a noninvasive infrared device has demonstrated its efficacy in tightening skin in various body regions. The use of this device in upper arm loose skin has not been investigated.
To determine the safety and efficacy of an infrared device to treat upper arm laxity in aged skin.
Twenty women with mild to very loose aged upper arm skin underwent two treatments with an infrared device 1 month apart. Nineteen patients completed the study with a 3-month follow-up. Outcome measures included investigator and participant evaluations of skin laxity improvement, blinded photographic assessments of skin tightening, and differences in circumferences and spectrophotometric analysis of collagen content in the treated arms. Two patients participated in histological evaluations.
The patient and investigator clinical assessments showed minimal improvement in skin laxity. There was a statistically significant decrease in arm circumference. Blinded photographic assessments and spectrophotometric analysis revealed no statistical improvement in skin laxity. The immediate post-treatment histological evaluations showed architectural disarray of dermal collagen and elastin.
An infrared device is safe, well tolerated, and minimally effective in treating aged upper arm skin laxity.
To evaluate the clinical efficacy of non-ablative cutaneous radiofrequency (RF) facial rejuvenation.
Prospective study with longitudinal follow-up of a validation cohort set in an urban, private practice of an ambulatory facial plastic surgery center in southern California.
A consecutive sample was enrolled of 35 healthy adults with moderate facial aging, manifested by skin laxity, rhytids, and ptosis (brow, midface, jowls). Following intravenous sedation anesthesia, the study area was treated with 115-144 J/cm2 using the non-ablative RF device (ThermaCool TC). The main outcome measures were the objective measurement of brow height, investigator evaluation of skin parameters, a patient satisfaction questionnaire, and standardized photography, at fixed time intervals.
At 12 weeks, a statistically significant increase in mean vertical brow height of 1.6-2.4 mm was observed in patients treated exclusively with the RF device (p<0.0001). All skin parameters (laxity, wrinkles, clarity, pore size) were improved. Complications and side effects were minimal. Patients were uniformly satisfied.
The ThermaCool TC RF system represents a promising non-invasive method of obtaining moderate facial rejuvenation in the appropriately selected patient. Long-term results are pending.
Background and Objectives
This 6-month study evaluated the efficacy and safety of treatment with a nonablative radiofrequency (RF) device.Study Design/Materials and Methods
Eighty-six subjects received a single treatment with the ThermaCool TC™ System (Thermage, Inc., Hayward, CA) and were evaluated for 6 months after treatment.ResultsIndependent scoring of blinded photographs resulted in Fitzpatrick wrinkle score improvements of at least 1 point in 83.2% (99/119) of treated periorbital areas. Treating physicians, without reference to pre-treatment photographs, noted improvements in 28.9% (48/166) of treatment areas. Fifty percent (41/82) of subjects reported being satisfied or very satisfied with periorbital wrinkle reductions. Objective photographic analysis showed that 61.5% (40/65) of eyebrows were lifted by at least 0.5 mm. Rates and duration of edema/erythema were very low (e.g., vs. ablative procedures). Overall 2nd-degree burn incidence was 0.36% (21 per 5,858 RF applications). Three patients had small areas of residual scarring at 6 months.ConclusionsA single treatment with this RF tissue tightening (RFTT) device produces objective and subjective reductions in periorbital wrinkles, measurable changes in brow position, and acceptable epidermal safety. These changes were indicative of a thermally induced early tissue-tightening effect followed by additional tightening over a time course consistent with a thermal wound healing response. Lasers Surg. Med. 33:232–242, 2003. © 2003 Wiley-Liss, Inc.
Laxity and rhytids of the lower eyelids are common cosmetic concerns. Historically, correction has either been surgical through either transcutaneous or transconjunctival blepharoplasty or ablative through laser resurfacing or chemical peeling. Therapeutic options usually require significant postoperative healing and have the potential risk of scarring ectropion or pigmentary loss.
To report the use of a new technique that uses nonablative radiofrequency (NARF) to tighten noninvasively and nonsurgically the flaccid skin of the lower eyelids by treating the periorbital area to produce cosmetic improvement.
Nine patients with skin flaccidity of the lower eyelids had a single treatment session with NARF in a small area of skin in the periorbital region, specifically the zygomatic and/or temporal areas. All patients were treated with topical anesthesia only. The treatment lasted approximately 10 minutes. No postoperative care was required.
All of the nine patients in the study achieved cosmetic improvement of the eyelids ostensibly through skin contraction. All patients were able to return to their normal routines immediately. Although the results were gradual, patient satisfaction was remarkable. No complications were seen in this study.
This new procedure using NARF was successful in providing a safe, noninvasive, cosmetic improvement in these patients with excessive skin laxity of the lower eyelids. Postoperative morbidity, including down time and complications, was not seen.
Radiofrequency application through a proprietary device has recently been used for facial tissue tightening. Uniform volumetric heating of the dermis is created by passage of electrical current, while protection of the epidermis is maintained by concurrent cryogen cooling.
To objectively quantify the effectiveness of volumetric radiofrequency application on the face, we treated 10 patients on the left side of the face with radiofrequency and evaluated the changes in brow position, superior palpebral crease, angle of the eyebrow, and jowl surface area.
Uniform treatments were applied at 134 J/cm(2) to the left side of the forehead and 1 cm past midline, at 115 J/cm(2) to the left side of temple and cheeks, and at 97 J/cm(2) to the left side of the jaw line and inferior postauricular surface. Patients were evaluated at monthly intervals up to 3 months with digital photography. Morphologic changes were evaluated with the "measuring tool" and "angle tool" of the Mirror Suite imaging system for aligned frontal-view photographs (for eyebrow position, superior palpebral crease elevation, and eyebrow angle changes) and the "outline tool" for aligned oblique-view photographs (for jowl surface area changes).
At the end of 3 months on the side that was treated, patients exhibited on average 4.3 mm of brow elevation and 1.9 mm of superior palpebral crease elevation along the midpupillary line and an average of 2.4 mm of brow elevation along the lateral canthal line. There was no significant improvement of brow elevation along the lateral canthal line on the contralateral side. The peak angle of the ipsilateral eyebrow became slightly more acute by an average of 4.5 degrees after treatments. Moreover, the jowls on the lower part of the face, displayed a mean decrease of 22.6% in surface area after treatments. The nontreated side displayed a lack of eyebrow angle and jowl surface area changes.
The application of radiofrequency to the face provides quantifiable changes. The brow along the midpupillary line is elevated to a greater degree than the lateral brow. This is consistent with acute angle changes seen in the eyebrow. Improvements in the lower part of the face with radiofrequency application can be quantified by demonstrating a decrease jowl surface. Moreover, these measurement techniques can be useful tools for evaluating other treatment parameters with radiofrequency application.
Unlike other nonablative devices that presumably stimulate neocolagen formation via various targets in the superfacial dermis, this device is a true "biostimulator," which causes immediate shortening of the collagen fibrils and neocollagen formation by a probable secondary wound healing response [11]. The results achieved by the ThermaCool have been extremely impressive and will almost certainly improve as the treatment methods are further optimized. many patients do not want the cost, risk, and downtime associated with surgical procedures, and this gives them an alternative. Minimally and noninvasive procedures have envolved as technolgy patients. We have always attempted to reduce tha teltale signs of surgery, but the patient-driven trend is avoidance of an "operated" look.
To compare the effectiveness of 1 and 2 radiofrequency (RF) treatments with the ThermaCool TC system (Thermage Inc, Hayward, Calif) on middle and lower face laxity.
Twenty patients with mild to moderate laxity of the middle and lower face were randomly assigned to receive either a single RF treatment or 2 treatments spaced 1 month apart. Treatment energy levels were titrated to patient tolerance and ranged from 85 to 135 J/cm(2). Acute clinical response was recorded after each session. Standardized photographs were taken before treatment and at 1 and 4 months after the last treatment. Using a percentage scale, 4 blinded physicians experienced in dermatologic laser therapy independently rated improvement in nasolabial folds, marionette lines, jowls, laxity under the chin, and overall appearance. In addition, subjects completed quality-of-life surveys 1 and 4 months after treatment. Each patient paid the same fee for involvement in the study.
Eleven patients received a single RF treatment, and 9 patients underwent 2 treatments. All subjects experienced mild edema and mild to moderate erythema as an acute clinical response; no patients experienced burns, skin breakdown, or scarring. At 4-month follow-up, patients in the 2-treatment group received higher scores in all categories of photographic analysis; the difference in improvement in the nasolabial folds was statistically significant (P = .04). In self-assessment ratings, individuals receiving 2 treatments reported more improvement than subjects in the single-treatment group 4 months after treatment (P = .03). In both treatment groups, physician photographic assessment demonstrated continued improvement in all subsites between the 1-month and 4-month assessments (P<.05). Although the overall change noted by both patients and physicians was modest in most patients, 75% of subjects (n = 15) stated they would consider paying for additional treatments.
Two RF treatments yielded significantly better improvement than a single treatment in the nasolabial folds. Significant improvement in laxity after treatment was seen between the 1- and 4-month follow-up visits in both single- and 2-treatment groups. Although overall improvements were modest in both groups, patient satisfaction was relatively high.
The development of nonablative monopolar capacitive radiofrequency technology (ThermaCool System, Thermage, Inc., Hayward, California) has contributed to the noninvasive trend in facial skin rejuvenation. In contrast to traditional ablative resurfacing techniques, the ThermaCool System protects the skin surface from injury while selectively heating the underlying dermis. Preservation of epidermal integrity minimizes recovery and the risk of complications. Published clinical evidence documents the efficacy of monopolar capacitive radiofrequency skin tightening and supports its use for mild to moderate facial skin laxity and rhytides. Currently, monopolar capacitive radiofrequency represents the gold standard of treatments designed to tighten skin in a noninvasive fashion.
Safety of radiofre-quency treatment over human skin previously injected with medium term injectable soft tissue augmentation materials: a controlled pilot trial
- Alan M R Levy
- U Pavjoni
Alan M, Levy R, Pavjoni U, et al. Safety of radiofre-quency treatment over human skin previously injected with medium term injectable soft tissue augmentation materials: a controlled pilot trial. Lasers Surg Med 2006;38(3):206–10.
Safety of radiofrequency treatment over human skin previously injected with medium term injectable soft tissue augmentation materials: a controlled pilot trial
- Alan