The impact of energy-based devices on sebum in acne vulgaris: A systematic review.

BACKGROUND: Acne vulgaris (AV) is a widespread inflammatory skin condition associated with increased sebum production, abnormal keratinization, bacterial overgrowth, and inflammation. Overactive sebaceous glands (SGs) produce excess sebum, promote Cutibacterium acnes growth, and affect acne development. Energy-based treatments (EBDs), including light therapy, photodynamic therapy (PDT), lasers, and radiofrequency (RF) devices, have emerged as effective treatment options. As the use of EBDs becomes more widespread, it is imperative to understand their effects on skin parameters, such as sebum, in AV. METHODS: Searches were conducted in Embase, PubMed, Web of Science, and the Cochrane Library. The studies included were randomized and nonrandomized trials on facial AV that used EBDs and featured objective casual sebum level (CSL) measurements via Sebumeter. Data synthesis involved percentage reductions in CSL at follow-ups compared to baseline. RESULTS: Twenty-three studies were analyzed. PDT and RF consistently reduced CSL by 30%-40% and 30%-35%, respectively. Laser therapy showed lesser reductions, whereas light therapy varied significantly and studies had a high risk of bias. All EBD therapies were more effective than no treatment and PDT was superior to light monotherapy. Laser therapy combined with fractional microneedling radiofrequency (FMR) or as a standalone was more effective than laser alone. CONCLUSION: Noninvasive sebum measurement provides valuable insights into AV treatment efficacy. PDT, lasers, especially the 1450-nm diode laser, and FMR are promising for reducing sebum. Standardization of measurement techniques and further research are vital for enhancing treatment personalization, reducing side effects, and improving AV management.

Effect of sequential delivery of 1- and 2-MHz bipolar microneedling radiofrequency energy on thermal tissue reactions in a minipig model.

BACKGROUND: Bipolar microneedling radiofrequency (RF) treatment generates different patterns of thermal reactions, depending on the skin impedance and RF treatment parameters, including the frequency, power, conduction time, settings of sub-pulse packs, and penetrating depth and type of microneedles used. We compared the effect of sequential delivery of 1- and 2-MHz bipolar RF energy to in vivo minipig skin on thermal tissue reaction. METHODS: RF treatments at frequencies of 1 and 2 MHz were sequentially delivered to minipigs' skin in vivo. A histological study was performed to analyze RF-induced skin reactions at 1-h and at 3-, 7-, and 14-days post-treatment. RESULTS: The skin specimens demonstrated that the two different frequencies of RF treatment generated mixed patterns of the peri-electrode coagulative necrosis (PECN) according to the experimental settings and tissue impedance. In the PECN zone, the tissue coagulation induced by the first RF treatment was surrounded by the effect of the later RF treatment at the other RF frequency. In the inter-electrode non-necrotic thermal reaction zone, the effect of the latter RF treatment was widespread and deep through the dermis, which had received RF treatment at the other frequency first. The delivery of pulsed-type RF energy at sub-pulse packs of 6 or 10 provided effective RF delivery over long conduction time without excessive thermal damage of the epidermis. Nonetheless, by sequential delivery of two different RF frequencies, RF-induced tissue reactions were found to be markedly enhanced. CONCLUSION: The sequential delivery of 1- and 2-MHz RF energy induces novel histological patterns of tissue reactions, which can synergistically enhance the thermostimulatory effects of each RF setting. Moreover, variations in patterns of tissue reactions can be generated by regulating the order of frequencies and the number of sub-pulse packs of RF used.

A retrospective study of non-insulated microneedle radiofrequency on wrinkles of facial photoaging subjects.

Non-insulated microneedle radiofrequency (NIMNRF) is a method of promoting dermal collagen shrinking and remodeling with minor injury reducing wrinkles. We conducted a 3-years retrospective observation on wrinkles of facial photoaging subjects treated with NIMNRF in Chinese subjects to demonstrate the efficacy and side effects. Chinese subjects clinically diagnosed as facial photoaging treated with MNRF in the Laser Center of The First Hospital of China Medical University and Guangzhou Mylike Medical Cosmetic Hospital from Jan 1, 2018 to Dec 31, 2021 were enrolled in this study. Inclusion criteria included. Each subject was treated with NIMNRF for 1-3 sessions, with a 3-month interval. At baseline and 3 months after each treatment, a Wrinkle Assessment Scale (WAS) was used to score the wrinkles in 10 areas. The total WAS score and WAS improvement rate was assessed at each time point. A total of 96 subjects, aged 25-65 years old, received at least one session of NIMNRF were enrolled. 63, 24, 9 of them received 1, 2 or 3 sessions, respectively. The total WAS score decreased from 14.65 ± 9.20 to 11.51 ± 8.70 after Session 1, from 15.92 ± 9.48 to 12.17 ± 8.83 after Session 2 and from 17.56 ± 6.99 to 11.11 ± 7.13 after Session 3 (P < 0.01). The WAS improvement rate was 25.61%, 30.69% and 39.82% after 1, 2, 3 sessions, respectively. As for subjects in different age groups, the improvement rate decreased with age, from 39.13% in 25-30 years old group to 16.39% in over 60 years old group after Session 1 (P < 0.05). Better efficacy and less sessions of treatments were conducted in younger subjects. NIMNRF can be used in the treatment of facial wrinkles in photoaging subjects, especially in youngster as better efficacy.

Rotational radiofrequency-based technology leads to adipose tissue reduction and contouring effect in the thighs, abdomen, and flanks.

BACKGROUND: Excess body adiposity and skin irregularities represent a major problem in today's society. Currently, radiofrequency-based devices constitute an increasingly popular medical-aesthetic application and a powerful non-invasive method to combat this problem. OBJECTIVE: This study aims to determine the efficacy and safety of the high-frequency device Zionic™ (Termosalud, Inc., Gijón, Spain) in reducing body contouring and improving skin appearance in the abdomen/flanks or thighs. MATERIALS AND METHODS: Thirty nine individuals were treated with the Zionic™ device in the abdomen/flanks or thighs. A total of 8 sessions of 40-50 min each, 72/96 h apart were performed. At baseline, body measurements were taken including photographs, body contours, and ultrasound scans to assess dermal thickness, dermal echogenicity, and subcutaneous fat thickness. The measurements were repeated after the eight sessions for comparison and analysis. Quantitative data was complemented with a customized survey to evaluate participants satisfaction level. RESULTS: At the follow-up visit, a significant average reduction of 3% in abdomen/flanks circumferences and 2% in thighs contours was noticed. Abdomen/flanks and thighs subcutaneous fat layer thickness was significantly reduced by 8% and 6%, respectively. Dermal echogenicity changes, related to skin collagen content and organization, showed non-significant increasing tendencies of 7% for abdomen/flanks and 8% for thighs. Thighs dermal thickness was significantly increased by 6%. Results were associated to a high satisfaction level (80%) and no severe adverse events. CONCLUSION: Zionic™ treatment is a safe, effective, and well-tolerated noninvasive procedure for body contouring and improvement of skin properties in abdomen, flanks, and thighs.

Long-term efficacy of fractional microneedle radiofrequency versus botulinum toxin-A in primary axillary hyperhidrosis: a randomized controlled trial.

Primary axillary hyperhidrosis is an idiopathic disorder that creates severe psycho-social burden due to excessive uncontrolled sweating. Various therapeutic agents have been described, but each has its own limitations. The use of fractional microneedling radiofrequency has emerged lately with promising results. This study aimed to determine the efficacy and safety of fractional microneedle radiofrequency in comparison to Botulinum toxin-A (BT-A) in patients with primary axillary hyperhidrosis. In this randomized controlled clinical trial, 20 patients (40 sides) were randomized to either fractional microneedle radiofrequency (4 sessions at 3-week intervals) or BT-A (single session), where each side received one of the treatment modalities. Efficacy was measured at 3, 6 and 12 months using Minor's starch iodine test, HDSS score, Hqol questionnaire, and patient satisfaction. Fractional microneedle radiofrequency, although showed moderate efficacy, is inferior to BT-A regarding longitudinal efficacy at 12 months, as well as patients' satisfaction. Both treatment modalities showed to be equally safe, but fractional microneedle radiofrequency procedure was substantially more painful. In conclusion, fractional microneedle radiofrequency does not offer a better substitute to BT-A in primary axillary hyperhidrosis. BT-A shows higher efficacy, is less painful, less expensive, and needs a smaller number of sessions.

Efficacy and safety of a novel monopolar radiofrequency device with a continuous water-cooling system in patients with age-related facial volume loss.

BACKGROUND: Esthetic radiofrequency (RF) technology has much attracted public attention with the increasing demand for skin rejuvenation. A continuous water cooling-based monopolar RF (MRF) device was designed for the first time to protect the epidermis and maximize clinical outcomes. OBJECTIVE: Assess the efficacy and safety of the proposed MRF device in patients with mild-to-moderate sunken cheeks and jawline laxity. METHODS: Twenty-one patients underwent a single session of MRF treatment. Quantitative analysis was performed using a 3D imaging technique. Postprocedural clinical improvements were assessed with the Merz Scale. Regarding safety, adverse events (AEs), thermal sensation (TS) and pain intensity were explored. Patient satisfaction was surveyed with the Self-Assessment Questionnaire (SAQ). RESULTS: The follow-up investigation demonstrated that facial volume increased across the cheek and jawline, with lifting effects throughout the treatment area. The Merz Scale assessment revealed that sunken cheeks, sagging jawlines and wrinkles were markedly improved. In addition, there were transient AEs, mild TS and moderate pain. In SAQ, 81% patients were satisfied with the procedure. CONCLUSIONS: This study provided quantitative evidence for postprocedural volumetric increases along with enhanced lifting effects, strongly implying that the proposed MRF device can be an attractive option for improving facial skin volume loss and laxity.

Combinations of Energy-based Devices plus isotretinoin for management of acne and acne scars: A systematic review.

BACKGROUND AND OBJECTIVE: A 6-month interval between systemic isotretinoin (ISO) and the initiation of energy-based interventions has been recommended, due to concerns about keloid formation and delayed wound healing. While this postponement goes against the current trend of early intervention for acne scarring. This systematic review evaluates the efficacy, safety, and patient satisfaction of combinations of ISO with energy-based devices (EBD). STUDY DESIGN/METHODS AND MATERIALS: PubMed, Embase, Web of Science, Cochrane Library, and Cochrane Central Register of Controlled Trials were comprehensively searched up to April 2023 according to PRISMA guidelines. Two independent reviewers screened the titles and abstracts to select articles. The quality of the literature was assessed for each study design. RESULTS: A total of 16 studies addressing the efficacy and safety of energy-based modalities combined with ISO were identified, including six randomized controlled trials (RCTs), two case series, seven cohort studies, and one case report. ISO combinations with intense pulsed light (IPL), fractional ablative CO2 laser, pulsed dye laser (PDL), non-ablative fractional laser (NAFL) and fractional microneedle radiofrequency (FMRF) have been tested for improving acne severity, acne scarring and erythema. CONCLUSION: The current evidence does not justify delaying the use of EBDs for patients who have recently undergone or are currently receiving ISO treatment. Evidence-based treatments such as PDL, NAFL, and FMRF etc. are suggested relatively safe and effective in treating acne and acne scarring.

Facial tightening using a novel vacuum-assisted microneedle fractional radiofrequency system: A prospective, randomized, split-face study.

BACKGROUND: The microneedle fractional radiofrequency system (MFRS) is able to rejuvenate facial appearance by heating and coagulating certain depth of skin tissue. OBJECTIVE: To evaluate the safety and efficacy of a novel vacuum-assisted MFRS for facial contour tightening. METHODS: This prospective, randomized, split-face study included 21 patients who underwent three treatments with a vacuum-assisted MFRS at 1-month intervals. Half of the face was treated with the MFRS; the other half was untreated (control). Facial volume changes and wrinkles were objectively measured using a three-dimensional imaging system and VISIA-CR. RESULTS: Volume changes of the treated midface were -0.24 ± 0.75, -0.59 ± 0.92, and -0.55 ± 0.65 mL at 1, 3, 6 months follow-up; however, measurements of the control side were 0.08 ± 0.70, -0.08 ± 0.53, and - 0.10 ± 0.86 mL, indicating significant reductions (p < 0.05). The number of facial wrinkles on the treated side was significantly reduced to 12.44 ± 4.85 at 3 months and sustained at 6 months (11.11 ± 4.100) compared to the control side (14.89 ± 5.26 and 13.22 ± 4.44, respectively; p < 0.05). No long-term side effects occurred. CONCLUSION: The vacuum-assisted MFRS is safe and effective and is recommended for improving facial tightening and reducing wrinkles. This technology is sufficient to ensure the insertion depth, thus helping to improve the treatment accuracy and safety. The MFRS provides sustained effects for at least 6 months.

Comparing Energy-Based Devices for Striae Improvement: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.

BACKGROUND: Striae distensae (SD) are cutaneous lesions that are caused by hormones or mechanical stress leading to rapid expansion of skin. Therefore, SD are now a cosmetic concern. However, improving SD is notoriously difficult. Among different treatments, energy-based devices (EBDs) are much more effective and controllable. OBJECTIVE: The aim of this review was to determine the most effective type of EBD for improving the appearance of striae. MATERIALS AND METHODS: The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The population comprised patients suffering from striae. Different types of EBDs used to improve striae were compared. The primary outcome of the reduction in the width of striae was evaluated. A random-effects model was performed. The means and standard deviations were extracted. RESULTS: Eighteen randomized controlled trials were included. The network meta-analysis revealed that after a comparison among the 4 types of EBDs, no significant differences were observed in the reduction of striae width. CONCLUSION: Radiofrequency, ablative lasers, nonablative lasers, and intense pulsed light are all effective treatments for reducing the striae width. None of them was superior to the others. However, radiofrequency and ablative lasers may have the highest chance of improving the appearance of striae.

Correction of age-related changes in the skin at the dermal and subdermal level using radiofrequency macroneedling therapy.

BACKGROUND: The negative effects of skin aging are primarily related to the destruction of dermal architectural structure. More specifically, this includes changes in the spatial arrangement of collagen, elastin fibers, mucopolysaccharides, proteoglycans, and ground substances. AIMS: The purpose of this study is to investigate the histologic effects of dermal and subdermal tissue after a controlled single treatment with radiofrequency (RF) macroneedling. This therapy provides a controlled, localized, thermal effect on the dermis whereby triggering the body's own healing processes of extracellular matrix remodeling. Clinically benefits include skin tightening. METHODS: Biopsies were obtained for histologic evaluation from four patients (n = 4), 4 weeks after completing a single RF macroneedling facial treatment. RESULTS: Age-related changes of the dermal and subdermal architecture were observed at baseline. After treatment, all biopsies demonstrated an increase in epidermal cells, collagen, elastin, fibroblasts, vasculature, and a decrease in inflammatory cells. CONCLUSIONS: The results of this histologic study confirm a significant "subsurfacing" thermal effect from the noncoagulative ascendant thermal injury. The obtained results characterize RF macroneedling therapy as an effective method for correcting age-related changes in facial skin.

Body contouring effects of at-home beauty device equipped with suction, radiofrequency, and electrical muscle stimulation functions.

BACKGROUND: With the rise in interest and demand for body contouring, beauty devices have continuously developed. Suction can aid in increasing the rate of fat breakdown by inducing a massage-like effect, thereby increasing blood flow. Moreover, radiofrequency (RF) can boost fibroblast activity and help reduce cellulite. In addition, electrical muscle stimulation (EMS) can use electrical stimulation to induce muscle contraction, leading to an athletic, and skin elasticity-increasing effect. AIMS: This study aimed to assess the effects of body contouring, such as cellulite and swelling, in healthy Korean women to objectively prove the efficacy of an at-home beauty device equipped with suction, RF, and EMS functions. METHODS: For 8 weeks, 21 participants used the at-home beauty device 3 days a week on their abdomen, thighs, and left calf. Validity assessments and subjective surveys were conducted at 4 and 8 weeks, including the first visit. RESULTS: The results of the validity assessments revealed that cellulite, swelling, elasticity, femoral skin texture, and dermal density were significantly (p < 0.05) improved in the experimental group compared with those at the baseline. CONCLUSIONS: The results of this study demonstrate that the combination of suction, RF, and EMS function is effective for body skin, fat, and body shape management. For better body-contouring effects, combining the beauty device with regular exercise and healthy eating habits is recommended.

Microplasma radio frequency technology using stationary tips on pig skin: A histological study.

OBJECTIVE: To investigate the histological properties of microplasma radiofrequency (MPRF) using a stationary tip in different treatment strategies on porcine skin. METHODS: Two Bama miniature pigs received MPRF treatment with two types of stationary tips in eight groups of parameters (power, duration, and pass) on dorsal skin. Skin samples were collected from each treatment zone immediately, at 1 week and 1, 3, and 6 months after treatment. Hematoxylin and eosin (HE) and Masson staining were performed to assess histologic changes as well as neocollagenesis. The dynamic changes of heat shock protein 47 (HSP47) and heat shock protein 72 (HSP72) were also detected by immunohistochemistry. RESULTS: Skin damage increased with pulse energy, duration, and pass. Longer durations or repeated treatments may cause particularly severe skin damage. During the wound healing process, the newborn collagen of the dermis is rearranged. The distribution of HSP47 and HSP72 was consistent with the extent of collagen remodeling. It peaked 1 month after treatment. CONCLUSION: MPRF can effectively cause epidermal ablation, dermal collagen hyperplasia, and remodeling. Increasing power should be the first choice when increasing treatment intensity. For longer durations or repeated treatments, caution should be taken to avoid excessive skin trauma.

The effects of a real-time temperature monitoring non-ablative monopolar radiofrequency technology on vulvovaginal atrophy symptoms in postmenopausal Chinese women.

BACKGROUND: Vulvovaginal atrophy (VVA) includes a wide range of conditions affecting the reproductive and urinary systems, often requiring careful evaluation and management for optimal health. AIMS: This study aims to evaluate the symptom management effects of a real time temperature-monitored non-ablative RF device for the treatment of postmenopausal Chinese women with VVA symptoms. METHODS: This pilot study involved 24 postmenopausal Chinese women with one or more VVA symptoms, who wished to remain sexually active. VHIS, VAS, and FSFI were used to track and evaluate various aspects of the patient's condition. Analyses were conducted at the end of the study to verify the statistical significance of the treatment's results. RESULTS: All patients reported substantial, statistically significant, improvements on every VVA symptom tracked. Approximately 80% of the patients reported total symptom reversal at 12-week post-treatment follow-up. CONCLUSION: This pilot study demonstrated that non-ablative, monopolar RF technology equipped with real time temperature monitoring is feasible and safe in the treatment of postmenopausal women with VVA symptoms, and efficacious at up to 12 weeks post-treatment.

Efficacy and safety of bipolar fractional radiofrequency vs. 2940-nm Er:YAG ablative fractional laser in striae distensae treatment: A split abdomen study.

BACKGROUND: Striae distensae (SD) is a challenging cosmetic condition. Ablative fractional laser (AFL) is an effective method for treating SD. Recently, fractional radiofrequency (FRF) has been shown to be a promising treatment for SD; however, few studies have shown the differences between FRF and AFL in the treatment of SD. AIMS: This study aimed to evaluate and compare the clinical efficacy and safety of bipolar FRF with 2940-nm erbium yttrium aluminum garnet (Er:YAG) AFL in the treatment of SD. PATIENTS/METHODS: Twenty volunteers with abdominal SD were enrolled in this study. One half of the abdomen was treated with 2940-nm Er:YAG AFL, whereas the other half was treated with bipolar FRF, with three sessions at 4-week intervals. Photographic evaluations of clinical improvement were conducted by two independent investigators before and after treatment, and the patients provided self-assessments. Two participants underwent three punch biopsies, one before treatment and two obtained from bilateral representative skin lesions on the abdomen 3 months following the final treatment. RESULTS: Clinical improvements were observed in SD on both sides of the abdomen after the two treatments. Post-treatment skin biopsies revealed increased thickness in the epidermis and dermis, and higher collagen and elastin density compared to those at the baseline. No statistically significant differences were observed in the clinical outcomes between the two treatment approaches. CONCLUSIONS: The efficacy and safety of bipolar FRF treatment are comparable to those of 2940-nm Er:YAG AFL treatment, providing an alternative and effective treatment for SD.

Pilot study of fractional microneedling radiofrequency for hidradenitis suppurativa assessed by clinical response and histology.

BACKGROUND: Hidradenitis suppurativa (HS) is a devastating chronic inflammatory skin disease with frequent recurrences. Various systemic treatments and procedures have been used but the efficacy of fractional microneedling radiofrequency (FMR) has not been reported. AIM: To evaluate the clinical and histological efficacy of FMR in the treatment of HS lesions. METHODS: An 8-week, prospective, split-body, unblinded study was conducted, which enrolled 10 adult patients with mild to moderate HS to receive 3 sessions of FMR treatment biweekly. HS severity was assessed using the number and type of lesions, HS Physician Global Assessment (HS-PGA) and the modified Sartorius score (mSS). Skin biopsies were performed on participants to assess change in inflammation before and after FMR. RESULTS: Severity of HS was significantly reduced on the FMR-treated side of the body, but not on the control side. Inflammatory HS lesions were significantly reduced after 4 weeks, while HS-PGA and mSS were significantly decreased after 6 weeks. Immunohistochemistry staining showed decreased expression of inflammatory markers including neutrophil elastases, interleukin (IL)-8 and IL-17, tumour necrosis factor-α, transforming growth factor-ß1 and matrix metalloproteinases. CONCLUSION: FMR may be a viable treatment option for mild to moderate HS.

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

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

Management of Primary Focal Hyperhidrosis: An Algorithmic Approach.

Hyperhidrosis (HH) is defined as perspiration beyond the level required to maintain temperature regulation. HH affects nearly 4.8% of the population in the United States. It can have a great impact on patient’s quality of life by disturbing daily activity, performance, confidence, social interactions, and mental health. In the majority of patients with HH (93%), the etiology of excess sweating is idiopathic, which classifies it as primary focal HH. Mild HH may be controlled with topical antiperspirants and lifestyle modifications. Based on the location of involvement, iontophoresis and botulinum toxin may be considered if the patient does not respond to topical therapies. Despite minimizing sweating, chronic use of systemic anticholinergics, in particular oxybutynin, may result in detrimental adverse effects such as dementia. Local surgery, radiofrequency, microwave, and lasers are other potential modalities for HH. Sympathectomy can be a last resort for the treatment of focal HH of the palmar, plantar, axillary, and craniofacial areas after failure of less invasive therapeutic options. In this review, we conducted a comprehensive search in the PubMed electronic database to summarize an algorithmic approach for the treatment of HH. This can help broaden options for managing this difficult disease. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5774.

Prospective Clinical Trial of the Latest Generation of Noninvasive Monopolar Radiofrequency for the Treatment of Facial and Upper Neck Skin Laxity.

BACKGROUND: Aging of the face and upper neck is a complex process characterized by loss of collagen and elastic fibers, resulting in clinical skin laxity. Noninvasive interventions such as monopolar capacitively coupled radiofrequency (MRF) have gained popularity, offering a safer and more convenient alternative to traditional surgical face lift. The latest MRF device features larger tips, vibration, cooling, and impedance matching. OBJECTIVE: We performed the first open-label clinical trial, measuring the efficacy, safety, and patient satisfaction of this device for noninvasive lifting and tightening of the face and upper neck. MATERIALS AND METHODS: Forty subjects 30 to 60 years of age with mild/moderate skin laxity of the face and upper neck were enrolled. After pretreatment with ketorolac 60 mg intramuscular injection, subjects underwent treatment with MRF. Follow-up evaluations were performed on Days 30, 60, and 180. RESULTS: Our study demonstrated that the newest generation MRF produced statistically significant improvement in skin laxity 6 months post-treatment, especially in the jowls and melolabial folds. According to the Investigator Global Aesthetic Improvement Score, 73% of subjects had improvement at 6 months post-treatment. Subject satisfaction and improvement questionnaires supported these findings. CONCLUSION: Our data coupled with the excellent adverse effect profile validates MRF as an attractive treatment modality for facial and upper neck skin laxity.