Combined treatment for skin laxity of the aging face with monopolar radiofrequency and intense focused ultrasound in Korean subjects

Background: Although various minimal invasive approaches are available for aging skin laxity, they alone may not lead to notably satisfactory results. Objective: To evaluate the effectiveness and safety of combination regimen with monopolar radiofrequency (MRF) and intense-focused ultrasound (IFUS) in facial lifting and tightening. Methods: Twenty-two Korean participants with aging face received a sequential single session of MRF and IFUS treatment. Objective and subjective assessments for improvement were performed at the 20-week post-treatment. Safety profiles were also recorded, and skin biopsies were taken at baseline and follow-up visit. Results: Based on the objective assessment for the overall facial skin tightening and laxity, 19 patients (90%) demonstrated “moderate” or better improvements (more than 25%) compared with baseline. Specifically, improvements of skin laxity and sagging, and droopy jaw line were more noticeable compared with that of superficial skin texture (P < 0.05). Subjective satisfactions were generally consistent with objective findings, and no serious adverse effect was observed. Histologic evaluation showed increased dermal collagen fibers throughout the dermis after treatments (P < 0.05). Conclusion: Combination treatment of MRF and IFUS has cumulative benefits for skin lifting and tightening with satisfactory safety profiles in Asian subjects.     

A pilot study of the efficacy of the POLARGEN® ultrahigh-frequency electric field (40.68 MHz) radiofrequency device in the treatment of facial contouring

Background: Various radiofrequency (RF) devices are used to treat skin laxity and face contouring, but few studies have examined ultrahigh-frequency (UHF) electric field (40.68 MHz) RF devices. Objective: To evaluate the efficacy and safety of a UHF electric field (40.68 MHz) RF device for skin tightening and face contouring. Methods: Ten patients each underwent four sessions of UHF electric field RF device treatment at 2-week intervals. Clinical improvement was evaluated with the patient satisfaction score using a six-point scale, and clinical photographs taken at every visit and 2 months after the RF treatment were assessed. Skin biopsies were obtained from one patient before the first treatment and immediately after the last treatment. Adverse reactions were recorded at every follow-up visit. Results: All patients were women with a mean age of 51.7 ± 7.2 years. The mean satisfaction score was 4.5 ± 0.9 immediately after the last treatment session. Cheek, jawline, and neck enhancement and tightening were apparent in all patients. Side effects were minimal, and there were no burns or major complications. Conclusions: The UHF electric field RF device was effective for skin tightening and facial contouring, without significant adverse reactions.     

Intense focused ultrasound (IFUS) with a modified parameter on facial tightening: A study on its safety and efficacy

Background: Intense focused ultrasound (IFUS) is a novel treatment modality for skin laxity. The delivery of thermal energy to the deeper tissue layers effectively tightens the skin but can also cause significant fat atrophy, limiting its use in patients with a lean face. Objectives: We sought to evaluate the safety and efficacy of modified IFUS on facial rejuvenation. Patients and methods: This was a retrospective, single-center study of 28 subjects with age-related facial laxity who underwent 3 sessions of IFUS (Ultraskin^TM, WONTECH Co., Daejeon, Korea) at an interval of four weeks, and then followed up for three months. IFUS was first applied using a 4-MHZ, 4.5-mm transducer followed by a 7-MHZ, 3-mm transducer. Approximately 200–300 treatment lines were applied to the face during each session. Standardized photographs were taken at baseline and follow-ups and were assessed by two independent dermatologists. A questionnaire was used to evaluate patient satisfaction and the incidence of adverse reactions. Results: Twenty-eight subjects with mild-to-moderate age-related facial laxity were included in the study. The mean age of the subjects was 48 (range 29–74) years. About 32.1% of the subjects showed significant improvement and 57.1% showed improvement of facial laxity in their follow-up photographs. All of them (100%) replied that they were either greatly satisfied or satisfied with the results at three-month follow-up. None of the subjects experienced any serious adverse events including fat atrophy after the procedure. Conclusion: Modified IFUS (three sessions, four weeks apart, 200–300 treatment lines per session) can be safely performed with good clinical results.     

Comparison of effect between high intense focused ultrasound devices for facial tightening: Evaluator-blinded,split-face study

Background: Various high intense focused ultrasound (HIFU) devices have been introduced in recent years for improving skin laxity, with satisfactory results. However, there is no comparative study on the efficacy and safety of available HIFU devices. Objective: To compare the efficacy and safety of two HIFU devices for facial skin tightening and subsequently, to validate the quantitative assessment. Methods and materials: We performed a split-face comparative study in 20 Korean patients. Two different HIFU devices were used on each side of the face. Patients received one treatment session on the same number of coagulative zones. Patient assessments were recorded. Three blinded clinicians evaluated paired pretreatment and post-treatment photographs. Quantitative assessment using a fixed point as well as a variable point was additionally performed for objective evaluation. Results: Qualitative assessments of both HIFU devices conducted by both clinicians and patients generally showed mild to moderate improvement, similar to previous studies. The two devices had similar efficacy in blinded clinician and quantitative assessment, although there were some differences in patient satisfaction and degree of pain. There was a correlation between clinician qualitative scores and quantitative values, which suggests successful skin tightening. Conclusion: To the author's knowledge, both HIFU devices tested can be used safely and effectively for facial tightening.     

High-Intensity Focused Ultrasound for the Treatment of Wrinkles and Skin Laxity in Seven Different Facial Areas

BackgroundHigh-intensity focused ultrasound (HIFU) treatment has recently emerged in response to the increasing demand for noninvasive procedures for skin lifting and tightening.ObjectiveThis study was aimed at evaluating the clinical efficacy of and patient satisfaction with HIFU treatment for wrinkles and laxity in seven different areas of the face in Asian skin.MethodsTwenty Korean patients with facial wrinkle and laxity were analyzed after a single session of HIFU treatment. Two independent, blinded clinicians evaluated the clinical improvement in seven areas of the face by comparison of standardized photographs obtained before, and at 3 and 6 months after treatment. Assessment of subjective satisfaction and adverse effects of treatment were done by using questionnaires.ResultsThe physicians'' evaluation and patients'' satisfaction with the clinical effects of HIFU in each area were similar regardless of the number of treatment shots. The jawline, cheek, and perioral areas were the sites where HIFU was most effective, in decreasing order. The adverse effects included erythema and swelling in six cases, and purpura and bruising in two cases. However, the adverse effects were mild and transient.ConclusionHIFU could be a safe, effective, and noninvasive procedure that can be used to improve facial wrinkles and skin laxity in Asian skin. It is particularly effective for clinical improvement in the jawline, cheek, and perioral areas.     

Facial skin rejuvenation by combination treatment of IPL followed by continuous and fractional radiofrequency

Objective: The objective of this study was to evaluate the safety and efficacy of combination facial treatment by 3 technologies. Materials and methods: Eleven patients completed the clinical trial that consisted of alternate treatments of intense pulsed light (IPL) in 3 sessions and continuous + fractional bipolar radiofrequency (RF) in 3 alternating sessions, 3 weeks apart. Follow-up visits were made at 6 and 12 weeks following the last treatment. Lesions were evaluated by photographs taken at baseline and at follow-up time points according to predetermined scales. Results: Results showed statistically significant improvement in wrinkling (24% after 6 weeks and 33% after 12 weeks), pigmentation (38% after 6 weeks and 62% after 12 weeks), vascular lesions (29% after 6 weeks and 67% after 12 weeks), and laxity (37% after 6 weeks and 40% after 12 weeks). Conclusions: Combination facial treatment by IPL, and continuous and fractional RF is safe and enables the treatment of a variety of facial lesions, taking advantage of accessible applicators for different clinical indications on the same device. Thus, comprehensive facial skin rejuvenation has become feasible.     

Complementary clinical effects of topical tightening treatment in conjunction with a radiofrequency procedure

Abstract

Background: Skin laxity and cellulite on the buttocks and thighs are two common cosmetic concerns. Skin tightening with radiofrequency (RF) devices has become increasingly popular. Objective: The purpose of this study is to evaluate the efficacy and safety of a topical skin laxity tightening agent when used in combination with an RF device. Methods: A double-blinded, randomized clinical trial enrolled twenty females with mild-to-moderate skin laxity on the posterior thighs/buttocks. Each subject underwent two monthly treatments with an RF source (Alma Accent) to both legs. Subjects were then randomized to apply a topical agent (Skinceuticals Body Tightening Concentrate) twice daily to only one designated thigh/buttock throughout the eight-week duration of the study. All subjects were evaluated for improvement in lifting, skin tone, radiance, firmness/tightness, skin texture, and overall appearance based on photographic evaluation by blinded investigators at 12 weeks following the final RF treatment. Results: A statistically significant improvement was found in the overall appearance on both sides treated with the RF device when compared to baseline. However, the area treated with the topical agent showed a statistically significantly greater degree of improvement than the side where no topical agent was applied. No adverse effects were reported. Conclusion: The use of a novel skin tightening agent used after RF procedures is both safe and effective for treatment of skin laxity on the buttocks and thighs. Combined therapy leads to a better result.     

A fractional 2940 nm short-pulsed,erbium-doped yttrium aluminium garnet laser is effective and minimally invasive for the treatment of photodamaged skin in Asians

Abstract

Background: Although ablative fractional laser for the facial photodamaged skin was effective and safe, there have been only limited reports regarding the efficacy and safety of fractional Er:YAG laser treatments for photodamaged facial skin in Asians. Objective: Our objective was to assess the efficacy and safety of the Er:YAG laser (2940 nm) using the ‘‘ablative’’ fractional resurfacing mode to treat photodamaged facial skin. Methods: A total of 29 Korean patients were treated for photodamaged facial skin using a fractional Er:YAG laser. The number of treatments was mean 2.3 sessions at two-week intervals. Independent investigators assessed the efficacy using standardized photographs. The patients’ satisfaction rate was also evaluated. Results: For dyspigmentation, 62.5% of the treated patients showed improvement greater than 26%. Regarding wrinkles, 50% of the treated patients showed improvement greater than 26%. All patients showed various degrees of improvement in skin laxity. Assessing the overall features, 62.5% of the study subjects showed improvement greater than 26%, and most of them (91.7%) reported that their subjective satisfaction rate was above ‘slight satisfaction’. Downtime accounted for approximately one week in most patients. Conclusions: A fractional Er:YAG laser can deliver an effective and minimally invasive treatment for photodamaged facial skin in Asians.     

Curative effects of microneedle fractional radiofrequency system on skin laxity in Asian patients: A prospective,double-blind,randomized, controlled face-split study

Background: To date, no studies compared curative effects of thermal lesions in deep and superficial dermal layers in the same patient (face-split study). Objective: To evaluate skin laxity effects of microneedle fractional radiofrequency induced thermal lesions in different dermal layers. Methods and Materials: 13 patients underwent three sessions of a randomized face-split microneedle fractional radiofrequency system (MFRS) treatment of deep dermal and superficial dermal layer. Skin laxity changes were evaluated objectively (digital images, 2 independent experts) and subjectively (patients’ satisfaction numerical rating). Results: 12 of 13 subjects completed a course of 3 treatments and a 1-year follow-up. Improvement of nasolabial folds in deep dermal approach was significantly better than that in superficial approach at three months (P=.0002) and 12 months (P=.0057) follow-up. Effects on infraorbital rhytides were only slightly better (P=.3531). Conclusion: MFRS is an effective method to improve skin laxity. Thermal lesion approach seems to provide better outcomes when applied to deep dermal layers. It is necessary to consider the skin thickness of different facial regions when choosing the treatment depth.     

Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin

Abstract

Introduction: Public interest in noninvasive, aesthetic treatments for the rejuvenation of appearance continues to grow. The following prospective, open-label, nonrandomized trial was conducted to evaluate the safety and efficacy of micro-focused ultrasound with visualization (MFU-V) for achieving lift and tightening of lax skin above the knee. Materials and methods: Healthy adult women (N = 30) with mild- to moderate bilateral skin laxity above the knees were enrolled. MFU-V was applied to a grid of eight 25 mm² squares above each knee. MFU-V was first applied using a 4 MHz, 4.5 mm transducer followed by a 7 MHz, 3.0 mm transducer. Approximately 480 treatment lines applied to each knee. The primary efficacy endpoint was lifting and tightening of lax skin above the knee as determined by the principle investigator using the Physician Global Aesthetic Improvement Scale (PGAIS). Results: Among 28 evaluable subjects, 24 subjects (86%) showed improved lifting and tightening of knee skin laxity at 90- and 180-day follow-up visits. Three subjects showed no change and the appearance of one subject worsened. There were no adverse events or evidence of skin injury. Conclusion: Similar to its safety and efficacy for tightening facial skin and reducing wrinkles, MFU-V is an effective, noninvasive method for reducing skin laxity and improving the appearance of skin above the knee. ClinicalTrials.gov Identifier: NCT01708434.     

Eyelid skin tightening: a novel ‘Niche’ for fractional CO2 rejuvenation

Background The periorbital area is a barometer of chronologic and environmental age for which patients usually seek rejuvenation; fractional CO₂ laser plays a key role among the variety of available dermatologic treatments. Objectives The purpose of this study is to evaluate the efficacy and safety of Fractional CO₂ laser in eyelid tightening and periorbital wrinkles. Methods Forty‐five patients received a range of 2–3 treatments in the upper, lower eyelids and periorbital area with a fractional laser device. Photographs were taken before and after each treatment and 2 weeks, 4 weeks, 3 months, 6 months and 12 months after the final treatment. The results were judged by three dermatologists who had not taken part in the treatments. Results One year after the last laser session, all patients showed global improvements in eyelid skin tightening: five patients (11.1%) achieved excellent improvement, 11 patients (24.5%) marked improvement, 15 patients (33.3%) moderate improvement and 14 subjects (31.1%) slight improvement. At the 1‐year follow‐up, the percentage of subjects with a lift in their eyebrows and consequently a widened palpebral fissure was 82.2 (37 patients), whereas 17.8% (eight patients) showed no eyebrow elevation. Conclusions Fractional CO₂ laser treatments allow dermatologists to achieve notable improvements in eyelid skin tightening, and eyebrow elevation safely and without significant side‐effects.     

Split-face histological and biochemical evaluation of tightening efficacy using temperature- and impedance-controlled continuous non-invasive radiofrequency energy

Background: Bipolar radiofrequency (RF) is capable of heating dermal collagen fibers and inducing skin tightening by collagen remodeling. Objective: To substantiate safety and improvement of skin laxity following skin heating with a novel temperature- and impedance-controlled non-invasive radiofrequency (RF) device by histological and biochemical evaluations. Methods: A split-face study was performed on 4 subjects who underwent 8 weekly RF sessions on one side of their face, leaving the other side an untreated control and then underwent facelift procedure. Clinical evaluation by photographs was done prior to the surgical procedure. Ex vivo fragments were harvested from both sides and compared. Morphometric analysis of dermal collagen fibers, collagen synthesis, and elastin synthesis evaluations were compared in triplicates. Results: Facial skin tightening was apparent in split-face photographs. A significant increase of 7.9% in dermal collagen content, and a significant increase of 34.7% in collagen synthesis were demonstrated in the treated samples. No statistically significant effect on elastin synthesis was detected. Conclusions: Skin tightening following treatment with non-invasive RF has proven histologically and biochemically to derive from increase in dermal collagen synthesis and content.     

Clinical evaluation of non-ablative radiofrequency facial rejuvenation

OBJECTIVE: To evaluate the clinical efficacy of non-ablative cutaneous radiofrequency (RF) facial rejuvenation. DESIGN: 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. METHODS: 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^TM). 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. RESULTS: 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&lt;0.0001). All skin parameters (laxity, wrinkles, clarity, pore size) were improved. Complications and side effects were minimal. Patients were uniformly satisfied. CONCLUSIONS: 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.     

Minoxidil 2% lotion for eyebrow enhancement: A randomized,double‐blind,placebo‐controlled,spilt‐face comparative study

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side‐effects were also evaluated. Thirty‐nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side‐effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis.     

Split-face comparison between single-band and dual-band pulsed light technology for treatment of photodamage

Background: Intense pulsed light (IPL) has a well-recognized role in the treatment of photodamaged skin. Objective: To assess the safety and efficacy of a novel single-band IPL handpiece versus dual-band IPL handpiece in the treatment of photodamage. Study design/Materials and methods: This was a prospective, single-center split-face study with 20 enrolled participants. Three treatments, 21 days apart, were administered to the subjects and follow-up was performed for 20 weeks. The left side of the face was treated with the single-band handpiece. The right side of the face was treated with the dual-band handpiece. Blinded investigators assessed the subjects’ skin texture, pigmented components of photodamage, and presence of telangiectasia both before and after treatment, utilizing a five-point scale. Results: Pigmented components of photodamage, skin texture, and presence of telangiectasias on the left and right side of the face were improved at the end of treatment. At 20-week follow-up, the side treated with single-band handpiece showed improvement in telangiectasia and pigmentation that was statistically superior to the contralateral side treated with the dual-band handpiece. Both devices equally improved textural changes. No adverse effects were noted with either device. Conclusion: Both single-band and dual-band IPL technology are safe and effective in the treatment of photodamaged facial skin. IPL treatment with a single-band handpiece yielded results comparable or superior to dual-band technology.     

Clinical evaluation and in-vivo analysis of the performance of a fractional infrared 1550 nm laser system for skin rejuvenation

Background: This study was done to demonstrate the safety and efficacy of a novel fractional 1550 nm laser device with a rolling mechanism (FRAX1550 Ellipse Medical, Horsholm, Denmark).

Objectives: To evaluated the effectiveness of the 1550 nm device for improvement in wrinkles, pigmentation, and texture on a six point (?1 to 4) global improvement scale.

Methods: Five female subjects between the ages of 44 and 71 years, with visible wrinkles and/or dyspigmentation were enrolled in the study. Two full face treatments were performed four weeks apart Follow-up visits at 1 and 3 months posttreatment were scheduled for photographic assessments. Assessment of improvement were performed by the investigators and two blinded evaluators through use of a six-point scale.

Results: All subjects demonstrated improvement in all monitored parameters. The mean improvement scores were: wrinkles 1.6, skin texture 1.8, and pigmentation 1.7. All score improvements were statistically significant. Biopsy was performed on one patient immediately post-treatment and showed 800 μ penetration depth at a treatment level of 88 mJ and 400 μ at 44 mJ.

Conclusions: The new rolling fractional 1550 nm laser device from this study offers improvement of aging facial skin with short downtime and minimal side effects.     

Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime,full-face skin rejuvenation

Background: In the recent years, there is a growth in demand for radiofrequency (RF)-based procedures to improve skin texture, laxity and contour. The new generation of systems allow non-invasive and fractional resurfacing treatments on one platform. Objective: The aim of this study was to evaluate the safety and efficacy of a new treatment protocol using a multisource RF, combining 3 different modalities in each patient: [1] non-ablative RF skin tightening, [2] fractional skin resurfacing, and [3] microneedling RF for non-ablative coagulation and collagen remodelling. Methods: 14 subjects were enrolled in this study using EndyMed PRO^? platform. Each patient had 8 non-ablative treatments and 4 fractional treatments (fractional skin resurfacing and Intensif). Results: The global aesthetic score was used to evaluate improvement. All patients had improvement in skin appearance. About 43% had excellent or very good improvement above 50%, 18% had good improvement between 25 and 50%, and the rest 39% had a mild improvement of < 25%. Downtime was minimal and no adverse effect was reported. Conclusions: Our data show significant improvement of skin texture, skin laxity and wrinkle reduction achieved using RF treatment platform.     

Use of a novel combined radiofrequency and ultrasound device for lipolysis,skin tightening and cellulite treatment

Introduction: Skin laxity and excessive subcutaneous fat are growing cosmetic concerns. The objective of this study is to evaluate the efficacy and safety of a novel radiofrequency and ultrasound workstation for lipolysis, circumference reduction, treatment of skin laxity and cellulite. Materials and methods: Two hundred seventy-five (235 women and 40 men) patients were enrolled into the study. Each patient received 3 treatment sessions, each session comprising Ultrasound and Radiofrequency treatments, at two-week intervals. Some received treatment for the abdomen, some for the thighs and some for both. Efficacy was assessed accordingly by measuring changes in abdominal circumference, thigh circumference and appearance of cellulite. Any adverse effect was noted. Result: Paired t-test between measurements at baseline and 4 weeks after 3rd session was significant amongst all the groups, showing that most patients showed improvement in abdominal and/or thigh circumferences. No significant adverse effects were noted during or after the treatment. Conclusion: A combination of alternating hot and cold module Ultrasound and Radiofrequency technologies is a safe and effective modality for lipolysis and to treat skin laxity and cellulite.     

Efficacy of a new fractional CO2 laser in the treatment of photodamage and acne scarring

This study evaluates the efficacy and safety of a novel fractional CO₂ laser device for improving facial rhytids, hyperpigmentation, enlarged pores, skin laxity, and acne scarring. Subjects (n= 15) were treated three to five times at 3‐week intervals. Biopsy specimens were used to evaluate healing response and neocollagenesis. Clinical improvement was rated on a quartile rating scale from digital photographs. Subject discomfort during treatment was evaluated on a scale of 0 to 5. Fourteen subjects who completed the study achieved good to excellent improvement in overall appearance, with 60% rated excellent. Improvement in photodamage was good to excellent in 92% of subjects, and reduction in rhytids was good to excellent in 85%. A total of 79% of subjects achieved good to excellent improvement in pore sizes and skin laxity. Subject discomfort during treatment was 3.0 ± 0.7. Erythema persisted for 2–3 days, and subjects resumed normal activities 1–2 days after the procedure. Histological slides after a single treatment showed new collagen formation. The SmartSkin fractional CO₂ system (Cynosure, Inc., Westford, MA, USA) provides significant improvement for the treatment of facial wrinkles, hyperpigmentation, pore size, and skin laxity associated with photodamage.     

A intense-focused ultrasound tightening for the treatment of infraorbital laxity

Abstract

Background: Infraorbital laxity is a common problem that increases with age. Blepharoplasty with lipectomy is a very commonly performed surgical procedure to treat this problem; however, it is invasive and is associated with the potential for re-emergence. Therefore, young patients may prefer a non-surgical procedure rather than to a surgical procedure. Intense-focused ultrasound (IFUS) has emerged as an effective, non-surgical, tissue-tightening procedure. Objective: This study assessed the safety and efficacy of IFUS (Ulthera^TM system, Ulthera Inc, Mesa, AZ, USA) for facial tightening in Asian patients with infraorbital laxity. Methods: We studied 15 patients who were treated with an IFUS device applied to both lower eyelids. The primary outcome measure was an objective improvement in a paired comparison of pre-treatment and post treatment (6 months) photographs. A secondary outcome measure was patient satisfaction as measured by a questionnaire. Results: The mean patient age was 50 years (range, 27–69). All patients received one to two treatments with intense-focused ultrasound. All patients in the study experienced both subjective and objective improvement. Conclusion: IFUS can be used as a non-invasive, skin-tightening procedure for infraorbital laxity. No serious, permanent, or delayed side effects were noted up to 6 months post treatment. Thus, this procedure can be effective and safe in the treatment of decreased laxity of the lower eyelids.