Background: Primary axillary hyperhidrosis (PAH) is a chronic idiopathic disorder causing major stress in patients. Among the common therapies for PAH, only surgical interventions have proven feasible as a permanent solution. Objective and Aim: The aim of this study was to evaluate the efficacy and safety of fractional microneedle radiofrequency (FMR) as an alternative permanent treatment for PAH with long-term follow-up. Materials and Methods: This was a single-blind, sham-controlled comparative study. Twenty-five patients with severe PAH were provided three treatments of FMR at 3-week intervals (the treatment group), and a control group was provided the sham treatment. Clinical efficacy was evaluated using the hyperhidrosis disease severity scale (HDSS) at baseline and the end of the study, as well as during the 1 year follow-up phase. Results: HDSS demonstrated significant improvement after treatment in the treatment group compared to the sham control. The mean (±standard deviation) of HDSS in the group being treated with radiofrequency was 2.50 (±0.88) after 1 year follow-up, and that of the control group was 3.38 (±0.49; P < 0.001). Follow-up results show that there were 10 patients (41.6%) with no relapse and 11 patients (45.9%) with relapse after 1 year. There was a significant correlation between HDSS changes in relapse and body mass index (BMI) (P = 0.03). Conclusion: Treatment of PAH with FMR is a safe and noninvasive procedure with a positive therapeutic effect on HDSS. It is recommended, however, that sessions of FMR be repeated after 1 year, particularly in overweight patients with high BMIs.
In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime.
Background. A consistent treatment has not been proposed for treatment of Striae Alba (SA). The present study was designed to compare the fractionated microneedle radiofrequency (FMR) alone and in combination with fractional carbon dioxide laser (FMR + CO2) in the treatment of SA. Methods. Forty-eight pairs of SA from six patients were selected. Right or left SAs were randomly assigned to one of the treatment groups. The surface area of the SA before and after treatment and clinical improvement using a four-point scale were measured at the baseline, after one and three months. Results. The mean age of the patients was years. The mean difference of the surface area between pre- and posttreatment in the FMR + CO2 group was significantly higher than that in the FMR group (). Clinical improvement scales showed significantly higher improvement in the FMR + CO2 group than in the FMR group in the first and second follow-up ( and 0.004, resp.). There were no major persistence side-effects in both groups. Conclusions. The results showed that FMR + CO2 laser was more effective than FMR alone in the treatment of SA.
BACKGROUND AND AIMS: The aging process is commonly associated with skin laxity in the lower face and neck. Conventional surgery can correct this at least to some extent, but is invasive. Fractional high-intensity focused radiofrequency delivered to the dermis with insulated microneedles has recently attracted attention in facial rejuvenation. The present pilot study was designed to assess the efficacy of HiFR for skin laxity of the lower face and neck.METHODS: Thirty-three patients (7 males, 26 females, age range 37-74 years) with mild to moderate skin laxity of the lower face/neck participated in the study. Three treatments were given at monthly intervals with protocols developed by the authors, three passes per session, at decreasing dermal depths for each pass. Histologic assessment of skin immediately after treatment was performed to identify the site and area of damage in the dermis. Clinical digital photography was taken at baseline and at 6 months after the final treatment session, based on which standardized computer measurement of improvement in the gnathion and cervicomental angles was the primary objective evaluation. A global assessment of improvement was graded by blinded assessors based on the photography. A telephone survey of patient satisfaction was performed at 12 months post-treatment. RESULTS: A significant post-treatment decrease in the cervicomental and gnathion angles was seen of 28.5° and 16.6°, respectively (P < 0.0001 for both). Histology immediately post-treatment showed a clear demarcated and roughly oval area of coagulation associated with the tip of the needle, confined to the dermis and not involving the epidermis. In the global assessment 81.8% of the patients achieved moderate or higher results, and 87% of patients were very satisfied or better. Downtime was minimal, lasting 3-4 days, and no persistent adverse events were recorded. CONCLUSIONS: Fractional HiFR proved safe and effective in the treatment of neck laxity in a large age range of patients, including the elderly. Lasers Surg. Med. 48:461-470, 2016. © 2016 Wiley Periodicals, Inc.
BACKGROUND: Fractional microneedling radiofrequency (FMR) is an emerging treatment modality, but its effect on rosacea has not been studied yet. OBJECTIVE: To investigate the potential impact of FMR treatment on clinical improvement and histologic changes in rosacea patients. MATERIALS AND METHODS: A 12-week, prospective, randomized, split-face clinical trial was conducted. Two sessions of FMR were performed on one side of the cheeks with 4-week interval and the other side remained untreated. Erythema index from DermaSpectrometer and a* value from Spectrophotometer CM-2002 were measured at each visit for the objective measurement of erythema. Histologic analysis of skin samples was also carried out. RESULTS: Clinical evaluation and photometric measurement revealed the reduction of redness in the treated side compared with untreated side and baseline. Erythema index decreased 13.6% and a* value decreased 6.8% at Week 12 compared with baseline. Reduced expression of markers related to inflammation, innate immunity, and angiogenesis was observed in immunohistochemical staining of tissue obtained after FMR treatment. CONCLUSION: Fractional microneedling radiofrequency treatment showed modest clinical and histologic improvement of rosacea, and it might be used as an alternative or in combination with other treatment methods.
It is clear from the experience of both Drs Clementoni and Weiner that each patient must be treated as an individual with a tailored approach to passes, parameters, and sessions. It is also clear that INFINI addresses laxity below the jawline and chin quickly and very effectively with minimal pain and downtime. Because of the remodelling process, the good results seen by patients a few weeks after their final session simply continue to improve, making INFINI the system of choice for laxity and lines in the neck and jowls, plus very efficient tightening and rejuvenation of the entire face. With INFINI, beauty becomes much more than skin deep, and the skin ageing clock is effectively turned back with lasting and natural-looking results.
In this multi-site case series, the efficacy of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for treating acne scars. A novel delivery system that uses insulated microneedles to deliver a desired thermal effect to multiple depths of the dermis while sparing the epidermis from RF injury was used. Four (4) healthy subjects from four different practices were evaluated and used in this case report. The subjects were treated between 3 or 4 times depending on the severity of the acne scars presented. The depth of thermal delivery was adjusted before each pass and all subjects received at a minimum, three passes to the treated area. Before and after photographs along with adverse effects were recorded. The theory behind the use of insulated needles with the active RF delivery at the distal tip is to allow for significant thermal injury to several layers of the dermis while avoiding thermal injury to the epidermis. This case report demonstrates significant improvement on acne scars and that all skin types should be safely treatable with minimum downtime realized.
Fractional microneedling radiofrequency (FMR) is one of the promising methods in acne treatment. Moreover, bipolar radiofrequency (BR) generates heat thereby which induces neocollagenosis. FMR may have the potential to be a safe and effective treatment for the patients both with acne and acne scar. This study was performed to compare the efficacy and safety of FMR and BR in acne and acne scar treatment. Furthermore, mechanism of the FMR treatment was investigated through skin tissues obtained from subjects. Twenty subjects with mild-to-moderate acne and acne scars were treated in a split-face manner with FMR and BR. Two sessions of treatment was done 4 weeks apart in a total 12-week prospective single-blind, randomized clinical trial. Clinical assessment and sebum measurement were carried out for the evaluation of efficacy and safety. Skin tissues were acquired for investigation of molecular changes. FMR was more effective for acne scar especially in icepick and boxcar scar compared to BR. Both inflammatory and non-inflammatory acne lesions decreased by 80 and 65 % in the FMR-treated side at the final visit of 12 weeks, respectively. FMR treatment resulted in significant reduction of sebum excretion. Both treatments showed no severe adverse effects other than erythema. The FMR showed superior efficacy in acne and acne scar compared with BR. Increased expression of TGFβ and collagen I and decreased expression of NF-κB, IL-8 are suggested to involve in the improvement of acne scar and acne lesion by FMR.
BACKGROUND AND OBJECTIVE: Skin aging results in physiological alterations in keratinocyte activities and epidermal function, as well as dermal changes. Yet, the cellular and molecular mechanisms that cause epidermal dysfunction during skin aging are not well understood. Recently, the role of epidermal hyaluronan (HA) as an active regulator of dynamic cellular processes is getting attention and alterations in HA metabolism are thought to be important in age-related epidermal dysfunction. Microneedle fractional radiofrequency (RF) has shown effects for improving cutaneous aging. However, little is known about the effects of fractional RF on the epidermal HA and epidermal function. We investigated the effect of microneedle fractional RF on the expression of epidermal HA in young and aged mice epidermis. MATERIALS AND METHODS: We performed fractional RF on the dorsal skin of 30 8-week-old (young) hairless mice and 15 47-week-old (aged) C57BL/6J mice. Skin samples were collected on day 1, 3, and 7. HA content was measured by ELISA. Gene expressions of CD 44, HABP4, and HAS3 were measured using real time RT-PCR. Immunohistochemistry for detection of HA, CD44, PCNA, and filaggrin were performed. RESULTS: HA content and the mRNA levels of HABP4, CD44, and HAS3 were upregulated in the epidermis of both young and aged mice after microneedle fractional RF treatment. The expression was increased from day 1 after treatment and increased expression persisted on day 7. Fractional RF treatment significantly increased PCNA and filaggrin expression only in the aged mice skin. CONCLUSION: Microneedle fractional RF increased epidermal HA and CD44 expression in both young and aged mice and reversed age-related epidermal dysfunction especially in aged mice, suggesting a new mechanism involved in the skin rejuvenation effect of microneedle fractional RF.
Post-inflammatory erythema is a common result of acne inflammation and is cosmetically unacceptable without effective treatment. Fractional microneedling radiofrequency (FMR) has potential for treatment of post-inflammatory erythema. The aim of this study was to evaluate the efficacy and safety of this treatment. A retrospective chart review was undertaken of 25 patients treated with 2 sessions of radiofrequency at 4-week intervals and 27 patients treated with oral antibiotics and/or topical agents. Efficacy was assessed through an investigator's global assessment of photographs, and the analysis of erythema with image analysis software and photometric devices. Histological changes resulting from the treatment were evaluated by skin biopsy. FMR treatment resulted in significant improvements in erythema with no severe adverse effects. Histological study revealed a reduction in vascular markers and inflammation. FMR is a safe and effective treatment for post-inflammatory erythema, with potential anti-inflammatory and anti-angiogenetic properties.
BACKGROUND/ OBJECTIVE: Primary axillary hyperhidrosis (PAH) creates social stress in patients. Although there are several options for treating PAH, only surgical modalities have conferred a permanent solution. This study evaluated the clinical effectiveness of fractionated microneedle radiofrequency (FMR) treatment for PAH. METHODS: This study is based on a single-blind, sham control comparative design. In all, 25 patients with severe PAH underwent three sessions of FMR at 3-week intervals. One side was treated with FMR while the other was sham controlled. Efficacy was evaluated using the hyperhidrosis disease severity scale (HDSS), sweating intensity visual analogue scale (VAS) and patient satisfaction at baseline, 3 weeks after each session and at 3 months after the last. Skin biopsies were obtained from two enrolled patients. RESULTS: The HDSS and VAS demonstrated significant improvement after treatment on the treated side in comparison with the control side. The mean ± SD of the HDSS after 21 weeks were 1.87 ± 0.61 and 3.38 ± 0.49 (P < 0.001) for the treated and the controlled side, respectively. The follow-up evaluation revealed that 79% of the patients showed a 1 or 2-score decrease in HDSS. In total, 80% of patients reported more than 50% satisfaction at the end of the study. Histopathological findings showed a decrease of the number of the sweat glands in the treated side, confirming the above findings. CONCLUSIONS: Treatment of PAH with FMR as a non-invasive modality can be a safe option with positive therapeutic effects on HDSS without any long-lasting side effects.
BACKGROUND: Various treatment modalities including non-invasive methods such as chemical peels, topical retinoids, microdermabrasion, minimally invasive techniques such as microneedling, fractional lasers, microneedling radiofrequency devices and invasive procedures such as acne scar surgeries and ablative lasers are used for acne scars, each with its own unique advantages and disadvantages. This study is a retrospective assessment of efficacy and safety of microneedling fractional radiofrequency in the treatment of acne scars. METHODS: Thirty one patients of skin types III-V with moderate and severe facial acne scarring received four sequential fractional radiofrequency treatments over a period of 6 months with an interval of 6 weeks between each session. Goodman & Baron's acne scar grading system was used for assessment by a side by side comparison of preoperative and post- operative photographs taken at their first visit and at the end of 3 months after the last session. RESULTS: Estimation of improvement with Goodman and Baron's Global Acne Scarring System showed that by qualitative assessment of 31 patients with grade 3 and grade 4 acne scars, 80.64% showed improvement by 2 grades and 19.35% showed improvement by 1 grade. Quantitative assessment showed that 58% of the patients had moderate, 29% had minimal, 9% had good and 3% showed very good improvement. Adverse effects were limited to transient pain, erythema, edema and hyperpigmentation. CONCLUSION: Microneedling fractional radiofrequency is efficacious for the treatment of moderate and severe acne scars.
Background: Fractional microneedle radiofrequency (FMR) devices deliver energy to the deep dermis through insulated microneedles without destroying the epidermis. These FMR devices have been shown to be effective for the treatment of wrinkles, acne scars and large pores. In this study it was postulated that FMR energy could specifically affect the sweat glands, preserving the skin surface even if sweat glands were seated in the deep dermis. Objective: To evaluate the efficacy and safety of FMR for primary axillary hyperhidrosis (PAH) treatment and to conduct a histological analysis before and after treatment. Methods: Twenty patients with PAH had 2 sessions of bipolar FMR treatment at 4-week intervals. Clinical improvement was evaluated using a Hyperhidrosis Disease Severity Scale (HDSS) and photographs were taken using the starch-iodine test at every visit and 2 months after the last treatment. The amount of sweat reduction was indirectly assessed using a Tewameter TM . Skin biopsies were obtained from 3 of the enrolled patients before and after treatment. The satisfaction and adverse reactions of the research participants were recorded at every follow-up visit. Results: HDSS scores decreased significantly from a baseline of 3.3 to 1.5 and 1.8 after the first and second months of posttreatment follow-up sessions, respectively (p < 0.001). In response to a subjective assessment at 1 month after the second treatment, 75% of patients (n = 15) had an HDSS score of 1 or 2, and 70% of patients (n = 14) expressed more than 50% improvement in their sweating. The starch-iodine reaction was also remarkably reduced in 95% of patients (n = 19) after FMR treatment. Histological findings showed a decrease in the number and size of both apocrine and eccrine glands 1 month after the final treatment. Side effects were minimal and included mild discomfort, transient swelling and postinflammatory hyperpigmentation. Conclusion: FMR treatment was effective for the treatment of PAH without significant adverse reactions due to direct volumetric heating of the lower dermis.
Background and Aims: Radiofrequency (RF) energy has gained popularity in skin rejuvenation and skin tightening. More recently, interstitial fractional delivery of RF energy using insulated microneedles introduced a new paradigm in this application of RF, typified by the INFINI system from Lutronic. The aim of this article is to clarify for the reader the basic principles of the application of RF energy in skin rejuvenation and tightening, and to suggest the reasons why the INFINI system offers clear advantages over others. Rationale: RF systems work on the principle of “Joule eating” where resistance in the target tissue to the RF current creates electrothermal damage: the higher the level of the current, the greater the damage. External RF systems, where electrodes are placed on the skin, appeared first: so-called “unipolar” RF where a single delivery electrode was placed over the target tissue and a return electrode was placed elsewhere, and “bipolar” RF, where the delivery and return electrodes were combined in a single handpiece. These systems had problems with accurate depth delivery, necessitated multiple treatments to get any noticeable effect, and required aggressive cooling to protect the epidermis from electrothermal damage. Interstitially-inserted uninsulated microneedle electrodes solved the depth problem, but still required epidermal cooling because the entire needle was the electrode. Finally, insulated microneedles were developed which could deliver precise zones of electrothermal damage limited to the dermis at preset depths, did not require cooling and represented a true fractional approach. The INFINI system uses insulated microneedling fractional RF (MFR), and offers these characteristics. Conclusions: With microengineered insulated needle electrodes, a unique insertion technology, a large range of depth settings (0.5 mm – 3.5 mm in 0.5 mm increments) and the ability to balance power levels (2.5 – 50 W in 2.5 W increments) with exposure times (100 ms – 1000 ms in 100 ms intervals), the INFINI offers the clinician a newand extremely adaptable approach to RF for skin rejuvenation and tightening. These features make this RF system, in the author’s opinion, superior to any other such system currently on the market.
A minimally invasive fractional radiofrequency microneedle (FRM) device has been used in skin rejuvenation and acne scars, and a recent pilot study demonstrated the positive therapeutic effect on acne. We evaluated the efficacy of FRM device for acne vulgaris in Asians and conducted objective measurement to assess its effect on sebum production. Twenty Korean patients with acne vulgaris received a single full-face FRM treatment. Outcome assessments included standardized photography, physician's global assessment, patient's satisfaction scores, acne lesion count, and objective measurements of casual sebum level (CSL) and sebum excretion rate (SER). They were evaluated at baseline and 2, 4, 8 weeks after the treatment. After a single FRM treatment, the CSL and the SER showed 30-60% and 70-80% reduction, respectively, at week 2 (P < 0.01), and remained below the baseline level until week 8. Physician's global improvement scores for acne severity and acne lesion count also revealed clinical improvement with maximum efficacy at week 2, but returned to the baseline in most patients by week 8. Patients' satisfaction scores (0-4) were above 2 on average, and adverse effects were minimal. This prospective study demonstrated the sebosuppressive effect from a single FRM treatment, but its therapeutic efficacy in acne requires further evaluation. Lasers Surg. Med. © 2013 Wiley Periodicals, Inc.
BACKGROUND: Fractionated microneedle radiofrequency (RF) devices have been reported to be effective in treatment of various dermatologic disorders. OBJECTIVES: To analyze histometric changes in skin-RF interactions using a fractionated microneedle delivery system. MATERIALS AND METHODS: RF energies were delivered using a fractionated microneedle device to an in vivo minipig model with penetration depths of 0.5, 1.0, 1.5, 2.0, 2.5, and 3.5 mm; RF conduction times of 20, 50, 100, and 1,000 ms; and energy levels of 5.0, 10.0, 20.0, 25.0, 37.5, and 50.0 V. RESULTS: Immediately after treatment, skin samples showed that the RF-induced coagulated columns in the dermis formed a cocoon-shaped zone of sublative thermal injury. Four days after the treatment, skin specimens demonstrated reepithelialization, and the dermal RF-induced coagulated columns showed mixed cellular infiltration, neovascularization, and granulation tissue formation. Microneedle depth and RF conduction times, but not energy level, significantly affected histometric values of RF-induced dermal coagulation. Microneedle RF treatment affected adnexal structures by coagulating follicular epithelium and perifollicular structures. CONCLUSIONS: Our data may be of use as an essential reference for choosing RF parameters in treatment of various skin conditions.
BACKGROUND: For periorbital rejuvenation, injection of botulinum toxin A (BoNT/A) is known to improve both static as well as dynamic wrinkles. A microneedle fractional radiofrequency (MFR) device was recently developed and is a novel and promising tool. OBJECTIVE: This study compares the effects of these two treatment modalities on periorbital static wrinkles and lines. METHODS: Twelve healthy women aged 20-59 years with periorbital wrinkles participated in this study. Each patient received one session of intradermal injection of BoNT/A on the left periorbital area and three sessions of MFR on the right. Clinical improvement, skin elasticity and subjective satisfaction were evaluated at every visit (baseline, 3, 6 and 18 weeks). RESULTS: BoNT/A injection showed superior effects at 3 and 6 weeks. However, the MFR device showed better improvement at 18 weeks. In skin biopsies, the expression of procollagen 3 and elastin was increased on the MFR side compared to the untreated skin and the BoNT/A injection side. The patient satisfaction surveys at 3 weeks showed better satisfaction on the BoNT/A treatment side compared to the MFR treatment side. At 18 weeks, there were no significant differences in patient satisfaction between the two sides. CONCLUSION: BoNT/A injection rapidly improved periorbital wrinkles, but the effect decreased up to week 18. Compared to BoNT/A injection, MFR therapy showed gradual and long-term improvement in periorbital rejuvenation.
All study centers reported improvements in all patients, ranging from subtle to excellent, with the large majority of the results being more towards the excellent than the subtle. Patient assessments coincided well with the clinicians’ findings. Results immediately after the final session were noted to continue to improve with the length of the follow-up period due to collagenesis, stimulated by the dermal deposition of electrothermal damage, being followed by matrix remodeling. All centers reported transient side effects after treatment, with mild edema lasting for around 24-48 hr and erythema lasting from 3-6 days. Mild crusting formed in some patients following pin-point bleeding, but resolved spontaneously in 3-5 days. Patients were extremely happy with the comparative lack of downtime required. Intra-treatment discomfort varied from very mild to moderate, but no patient in any of the centers failed to continue with their treatment program. Mild secondary hyperpigmentation was noted in 5 patients from the Italian center (2.3%) which was controlled completely with hydroquinone, but no serious side effect was reported by any center. MRF with the INFINI system was effective and safe in the treatment of skin rejuvenation and rhytides in all Fitzpatrick skin types examined from I to V, with no secondary hyperpigmentation seen in the darker Asian skin types particularly notable in the Indian center with skin types IV to V. The results obtained after the final treatment session continued to improve over time, and patient satisfaction with the procedure was very high with excellent compliance.