Efficacy and safety of non-invasive body tightening with high-intensity focused ultrasound (HIFU).

BACKGROUND: Noninvasive skin-tightening devices have become increasingly popular in response to increasing demand for improvements in skin laxity and tightening with minimal risk and recovery time. OBJECTIVE: We evaluated the efficacy and safety of HIFU for skin tightening in the face and body. METHODS: A total of 32 Korean subjects enrolled in this prospective clinical trial. The subjects were treated with HIFU to both cheeks, lower abdomen, and thigh. Skin elasticity was measured before and after treatment using a Cutometer (CT575, Courage and Khazaka® , Cologne, Germany). Three blinded, experienced dermatologists evaluated paired pre- and post-treatment (week 4 and 12) photographs according to the Global Aesthetic Improvement Scale (GAIS). Participants also completed self-assessments using GAIS. Subjects rated their pain on a numeric rating scale (NRS) immediately, 7 days, 4 weeks, and 12 weeks after treatment. RESULTS: Skin elasticity measured via a Cutometer was significantly improved 12 weeks after treatment at all treated sites (P<.05). Both IGAIS and SGAIS showed significant improvements 12 weeks after treatment. Immediately after treatment the mean NRS score was 3.00±1.586, but no pain was reported at 4 and 12 weeks post-treatment. No serious adverse effects were observed during the follow-up period. CONCLUSION: HIFU safely and effectively improves skin elasticity and clinical contouring of the face and body.

Improved methods for evaluating pre-clinical and histological effects of subcutaneous fat reduction using high-intensity focused ultrasound in a porcine model.

BACKGROUND: Non-invasive body sculpting procedures are becoming increasingly popular. High-intensity focused ultrasound (HIFU) treatment is a non-surgical fat reduction procedure that permanently destroys unwanted abdominal fat. Despite its increasing popularity, evaluation methods for the procedure have not yet been fully developed. AIMS: The objective of this study was to develop evaluation methods for HIFU for non-surgical, permanent fat reduction in the anterior abdomen using a porcine model. METHODS: The abdomens of female pigs (Sus scrofa, n = 7) were treated with a HIFU device (SCIZER™ , Classys Inc, Seoul, Korea). We examined treatment effects using photography, ultrasound, gross and microscopic pathology, and serum lipid and liver function level analysis, carbon tracer test, and histological examination in order to determine the mechanism of action, efficacy, and safety of the procedure. RESULTS: HIFU treatment effectively reduced abdominal fat in a porcine model; it accurately treated the target subcutaneous fat layer and the subcutaneous fat was reduced effectively via ultrasonic measurement after HIFU treatment. On histological staining (H&E, toluidine blue, oil red O and immunohistochemistry), we found that subcutaneous fat reduction occurred effectively via accurate treatment of the targeted subcutaneous fat layer. On hematological assay, there were changes within normal range, and values remained stable after 48 h. Via carbon tracer test, the migration of activated macrophages was identified within the axillary lymph node (LN). PPAR-delta, a protein defined by immunohistochemistry staining, was overexpressed in the early stage on days 1 and 7, but a gradual decreasing pattern was confirmed. CONCLUSION: We successfully used a HIFU device for body contouring and fat reduction in a pre-clinical study. These results provide that the essential clues toward the effective evaluation, guiding selection of the appropriate diagnostic investigations.

Non-invasive tumescent cryolipolysis using a new 4D handpiece: a comparative study with a porcine model.

BACKGROUND/PURPOSE: The growing demand for a youthful appearance, including a favorable body shape, has motivated recent developments in noninvasive body contouring techniques. Our aim was to investigate the efficacy and safety of a new version of a 4D handpiece-mounted cooling device for cryolipolysis with or without tumescent injections. METHODS: We conducted a side-by-side comparative study using two female porcine models. Two areas of each pig's left abdomen were treated using a conventional device and the new cooling device, and two areas of the right abdomen were also treated using the conventional and new cooling device, but both were combined with tumescent-solution injections. RESULTS: The conventional method alone yielded a 75.25% reduction in skin thickness, while the new cooling device alone yielded a 81.63% reduction. When paired with tumescent injections, the conventional device yielded a 86.3% reduction in skin thickness and the cooling device yielded a 85.9% reduction. Using histological analysis with H&E, oil red O, and toluidine blue stain, we confirmed that selective cryolipolysis was able to induce selective apoptosis of fat cells. CONCLUSION: This in vivo study presents a new 4D handpiece-assisted cooling device with tumescent anesthesia that is safe and effective for fat reduction.

Transcutaneous pneumatic injection of glucose solution: a morphometric evaluation of in vivo micropig skin and tissue-mimicking phantom.

BACKGROUND: Needle-free, transcutaneous pneumatic injection systems can be used to deliver therapeutic solutions to targeted layers of skin in a minimally invasive manner. METHODS: To evaluate jet infiltration patterns and tissue reactions, 5% isotonic and 20% hypertonic glucose solutions were pneumatically injected into in vivo micropig skin. Gelatin TM phantom was additionally prepared to analyze penetration and dispersion patterns for different experimental settings. RESULTS: As immediate tissue reactions in the in vivo micropig skin, distinct pneumatic injection injury zones (PIIZs) in the dermis, extending from the papillary dermis deep into the dermo-subcutaneous junction, were generated with the 5% and 20% glucose solutions and with pneumatic pressures of 4.64 and 5.7 bars, respectively. PIIZs markedly decreased in appearance at 1 day after treatment, accompanied by inflammatory cell infiltration, and disappeared at 7 days post-treatment with increased collagen and elastin production. In TM phantom study, the PIIZs created by 20% glucose mainly comprised a single, homogenous, round to oval zone, whereas those created by 5% glucose were irregular and multi-lobular. CONCLUSION: The present study suggests that transcutaneous pneumatic injection therapy may exert mechanical stimulatory effects, immediate tissue shrinkage via hypertonic solutions, and late tissue regeneration effects during wound healing.

High intensity focused ultrasound as a potential new modality for the treatment of pigmentary skin disorder.

BACKGROUND/PURPOSE: The clinical skin tightening benefits of high intensity focused ultrasound (HIFU) have been established, but its mechanism of action in pigmented skin disorders remains unknown. We macroscopically and histopathologically investigated dermatological changes after HIFU at different exposure doses in a UVB-induced guinea pig model of hyperpigmentation. METHODS: We applied HIFU irradiation at 0.1 and 0.2 J/cm(2) to UVB-induced spotty hyperpigmentation in guinea pig skin. The therapeutic effects of HIFU were judged based on gross appearance using photography, dermoscopy, and chromametry during a period of 3 weeks after HIFU irradiation. Histological assessments were performed using Fontana-Masson staining 1 day before and 3 weeks after HIFU irradiation. RESULTS: Macroscopically, UVB-induced hyperpigmentation was significantly reduced 2 weeks after HIFU with 0.2 J/cm(2) , and 3 weeks after HIFU with 0.1 J/cm(2) . Histopathologically, the heavy deposition of melanin in the epidermis induced by UVB exposure was reduced 3 weeks after HIFU irradiation. CONCLUSION: We confirmed that HIFU has a positive effect on UVB-induced hyperpigmentation as well as mechanical destructive activity. We suggest that HIFU may be useful as an alternative modality for human patients suffering from skin pigmentary conditions.

Potential synergistic effects of human placental extract and minoxidil on hair growth-promoting activity in C57BL/6J mice.

BACKGROUND: Human placenta extract (HPE) has been used to alleviate tiredness and promote wound healing, and for its antiageing functions; however, it has not yet been studied for its effects on hair growth. In the present study, we evaluated the in vitro effect of HPE on hair growth by observing its actions on human dermal papilla cells (DPCs). AIM: To define how HPE promotes induction of anagen hair growth during the telogen phase, and to understand the synergistic molecular mechanisms of HPE and minoxidil (MXD) actions on hair growth. METHODS: We examined the effects of HPE and MXD on C57BL6/J mice using haematoxylin and eosin staining, quantitative histomorphometry, hair growth scoring, immunohistochemistry and immunofluorescence on the dorsal skins of C57BL/6J mice. RESULTS: We found that HPE synergistically augmented the effects of MXD, a promoter of hair growth. In particular, histomorphometric analysis data indicated that subcutaneous injection of HPE induced an earlier anagen phase and prolonged the anagen phase. It also stimulated increases in both the number and size of hair follicles in groups treated with HPE alone and HPE + MXD. CONCLUSIONS: From our data, we conclude that HPE increases ß-catenin and Wnt3a expression levels. Overall, our findings suggest that HPE in combination with MXD has hair growth-promoting activity and is a potential novel therapeutic treatment for alopecia or baldness in humans.

Improved methods for selective cryolipolysis results in subcutaneous fat layer reduction in a porcine model.

BACKGROUND/AIMS: Cryolipolysis is a noninvasive method for the selective reduction of localized fat tissues. It has demonstrated efficacy in both clinical and preclinical trials; however, despite its popularity, its mechanisms of action and evaluation methods are not yet fully defined. The purpose of this study was to improved methods for cryolipolysis using a porcine model. METHODS: The abdomens of female PWG micro-pigs were treated with a cooling device (CRYOLIPO II(™)), and we examined the treatment effects using photography, three-dimensional photography, ultrasound, gross, and microscopic pathology, and serum lipid level analyses in order to determine the mechanism of action, efficacy, and safety of CRYOLIPO II(™). RESULTS: CRYOLIPO II(™) successfully reduced abdominal fat in our porcine model. Gross and microscopic histological results confirmed the noninvasive cold-induced selective subcutaneous fat destruction, and showed increases in pre-adipocyte differentiation and in the activation of lipid catabolism. In particular, we found that CRYOLIPO II(™) may increase PPARδ (delta) levels in adipose tissue at 30-60 days post-treatment. CONCLUSION: Fat reduction by cryolipolysis was successfully achieved in our porcine model. Thus, our findings indicate that CRYOLIPO II(™) may be a promising fat reduction device for body contouring and fat reduction in humans, and that cryolipolysis exerts its effects, at least partly, by targeting the PPARδ signaling pathway. These results show that both investigative and diagnostic potentials capacity.