Needleless laser injector versus needle injection for skin enhancement and rejuvenation effect of dermal filler.

BACKGROUND AND OBJECTIVES: A needleless laser-induced microjet injector is a novel transdermal drug delivery system that can rapidly inject a very small and precise drug dose into the skin with minimal pain and downtime. In this study, we aimed to compare the laser-induced microjet injection versus needle injection of polylactic acid/hyaluronic acid filler for skin enhancement and rejuvenation. PATIENTS AND METHODS: A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted. The enrolled patients underwent one treatment session of dermal filler injection using a laser-induced microjet injector on one half of the face or a traditional needle injection on the other half of the face. Evaluation was conducted at baseline before treatment and at 4, 12, and 24 weeks after treatment. RESULTS: A single treatment of filler injection with a laser-induced microjet injector resulted in similar improvements in skin hydration and elasticity as a single treatment of filler injection by using manual needle injection, with reduced pain, side effects, and decreased treatment time. CONCLUSIONS: Laser-induced microjet injector enabled not only the application of a controlled dose and filler depth but also even distribution, improved clinical efficacy, reduced pain and side effects, and sufficient time for clinicians to perform treatment.

Full-thickness skin rejuvenation by a novel dual-length microneedle radiofrequency device: A proof-of-concept study using human skin.

BACKGROUND: A novel dual-length microneedle radiofrequency (DLMR) device has been developed to achieve full-thickness skin rejuvenation by stimulating the papillary and reticular dermis simultaneously. This device's dual-level targeting concept need to be validated on human skin, although its clinical efficacy has been demonstrated in a previous study. OBJECTIVES: This study evaluated the dual-depth targeting capability and the ability to induce rejuvenation in each layer of vertical skin anatomy, that is, the epidermis, papillary dermis, and reticular dermis, using full-thickness human facial skin samples. METHODS: Human facial skin samples were obtained from 13 Asian patients who had facelift surgery. To validate the dual-depth targeting concept, DMLR-treated skin samples were analyzed using a digital microscope, thermal imaging, and hematoloxylin and eosin (H&E) staining immediately after DLMR application. On samples stained with H&E, Masson's tricrome, and Verhoeff-Van Gieson, histological observation and morphometric analysis were performed. Total collagen assay (TCA) and quantitative real-time polymerase chain reaction (qPCR) were used to assess changes in total collagen content and mRNA expression levels of collagen types I/III and vimentin, respectively. RESULTS: The DLMR device successfully induced thermal stimulation in the papillary and reticular dermis. The thickness, stacks, and dermal-epidermal junction convolution of the epidermis treated with DLMR were significantly increased. Collagen bundles in the dermis treated with DLMR exhibited a notable increase in thickness, density, and horizontal alignment. Dermal collagen levels were significantly higher in the morphometric and TCA data, as well as in the qPCR data for dermal matrix proteins. CONCLUSIONS: Our DLMR device independently and precisely targeted the papillary and reticular dermis, and it appears to be an effective modality for implementing full-thickness rejuvenation.

Irradiation with 590-nm yellow light-emitting diode light attenuates oxidative stress and modulates UVB-induced change of dermal fibroblasts.

Recently, light-emitting diode (LED)-based devices have emerged as effective and safe tools for the treatment of photoaged skin. However, few studies have been conducted to elucidate the underlying mechanism behind the effect on photoageing of LED light. In this study, we induced photoageing of human dermal fibroblasts (HDFs) with Ultraviolet B (UVB) irradiation and evaluated the ability of 590-nm LED radiation to induce recovery from oxidative stress, restore collagen formation and regulate inflammatory changes. Photoageing was induced in cultured human dermal fibroblasts (HDFs) using UVB irradiation of 50 mJ/cm2 . Then, the photoaged HDFs were irradiated with LED using a custom-built 590-nm LED device which emits light with an intensity of 38 mW/cm2 (irradiated for 900 s with 34.2 J/cm2 of total energy). LED irradiation significantly attenuated UVB-induced reactive oxygen species generation and UVB-induced phosphorylation of JNK, c-Fos and c-Jun. In addition, the procollagen levels were recovered significantly, and MMP-9 levels were significantly suppressed after LED irradiation. The UVB-induced phosphorylation levels of NF-κB and pro-inflammatory enzyme COX-2 also significantly decreased. Our results suggest that 590-nm yellow light irradiation may be an effective and safe anti-oxidative and anti-inflammatory treatment modality for photoaged skin.

Safety and efficacy of high-intensity focused ultrasound for treatment of periorbital, perioral, and neck wrinkles: Prospective open single-center single-arm confirmatory clinical trial.

Periorbital, perioral, and neck wrinkles are one of the most common concerns of aging skin. We evaluated the efficacy and safety of high-intensity focused ultrasound (HIFU) device with a 5.5-MHz transducer and a 2.0-mm focal depth for improving periorbital, perioral, and neck wrinkles. A total of 102 participants were enrolled, and 34 each were assigned to the periorbital, perioral, and neck groups. All subjects were treated with HIFU three times at 2-week intervals at the corresponding treatment site. Objective measurements and clinical evaluations were performed at 10 and 16 weeks after treatment. Based on the primary efficacy evaluation, the mean Cutometer R7 value was significantly increased at 10 weeks post-treatment compared to baseline in all treated groups. In addition, all other Cutometer values, PRIMOS and Antera 3D camera evaluation results, classification of wrinkle assessment results, and Subject Global Aesthetic Improvement Scale also showed that the periorbital, perioral, and neck wrinkles were significantly improved at 10 and 16 weeks post-treatment. No permanent adverse effects were observed during the follow-up period. HIFU treatment using 5.5-MHz transducers (2.0-mm focal depth) could be an effective and safe treatment modality for the treatment of periorbital, perioral, and neck wrinkles.

Split-face comparative trial of 785-nm picosecond neodymium:yttrium-aluminum-garnet laser and precision cryotherapy combination treatment for facial benign pigmented lesions.

Cryotherapy (or cryosurgery) has been performed to treat various skin lesions in the field of dermatology; however, to the best of our knowledge, no study has investigated its efficacy and safety for benign pigmented lesions. Therefore, we conducted a split-face study to evaluate the efficacy and safety of cryotherapy in the treatment of benign pigmented lesions. A total of five subjects were included. Picosecond laser therapy was performed to treat the whole face and cryotherapy for half the face. Four weeks after completing the treatment sessions, patients showed more clinical improvement on the laser and cryotherapy combination treatment side than on the laser-only side, with no adverse events. Our study demonstrated that cryotherapy is a potential adjuvant therapeutic modality for benign pigmented lesions.

A multicenter, randomized, double-blind comparison of two hyaluronic acid fillers in mid-face volume restoration in Asians: A 2-year extension study.

The long-term effectiveness and safety of hyaluronic acid fillers in mid-face volume restoration in Asians remain unclear. The objective of this study was to compare the long-term effectiveness and safety of Neuramis Volume Lidocaine (SHAPE-NVL) and Juvederm Voluma with Lidocaine (VYC-20L) in mid-face volume restoration in Asians. Overall, 88 Korean subjects with moderate-to-severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received SHAPE-NVL on one side and VYC-20L on the contralateral side of the face. Of the 81 subjects who completed the 48-week primary study, 69 subjects were enrolled in an extension study lasting 104 weeks. MFVDS score and global aesthetic improvement were assessed at each visit. Response was defined as a ≥1-point reduction in MFVDS. At weeks 36 and 48, the responder rates for SHAPE-NVL were 81.93% and 80.72%, while those for VYC-20L were 85.54% and 81.92%, respectively. At the 104-week visit, the responder rates were 73.91% and 72.46% for SHAPE-NVL and VYC-20L, respectively. No subjects experienced any serious adverse events during the trial. SHAPE-NVL and VYC-20L showed comparable longevity and safety in mid-face volume restoration over 2 years in Asians. Both had durable effects for up to 2 years with minimal safety concerns.

Evaluation of nail surface topography using a three-dimensional in vivo optical skin imaging system.

BACKGROUND: The analysis of nail surface topography is a subject of ever-increasing interest in dermatology, especially in cosmetic studies. However, there is no accurate and scientifically sound instrumental method that can identify and provide quantitative data on nail surface topography. MATERIALS AND METHODS: The right index fingers of 78 healthy individuals were examined. The severity of nail roughness was rated by two independent dermatologists on a scale of 1 to 3. Using the phaseshift rapid in vivo measurement of the skin (PRIMOS) system, three-dimensional microtopography was performed, and the roughness parameter values were calculated and evaluated. The relationship between clinical nail roughness grade and nail roughness parameter values obtained utilizing PRIMOS was evaluated. RESULTS: A moderate correlation was found between the roughness parameter values and the clinical roughness grade. Our study showed that an overall relationship exists between the nail roughness parameter values obtained using PRIMOS and clinically observed nail surface changes. CONCLUSION: With further studies, PRIMOS could be a valuable tool for clinicians and researchers for conducting an accurate and objective patient assessment in daily practice and demonstrating effectiveness of different therapies for nail dystrophy or evaluating cosmetic effects of various topical treatments in future clinical trials.

Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of a New Botulinum Toxin (HU-014) Versus OnabotulinumtoxinA in Subjects With Moderate-to-Severe Crow's Feet Lines.

BACKGROUND: HU-014, a newly introduced botulinum toxin type A, has not been investigated for its efficacy and safety in crow's feet line (CFL) treatment. OBJECTIVE: Here, we compared the efficacy and safety of HU-014 and onabotulinumtoxinA in CFL treatment. METHODS: This was a randomized, double-blind, active drug-controlled, multicenter, 16-week, Phase I/III study designed to determine the noninferiority of HU-014 compared with onabotulinumtoxinA in moderate-to-severe CFL treatment. In the Phase III study, 290 subjects were randomized at a 1:1 ratio to receive a single treatment of HU-014 or onabotulinumtoxinA. The primary endpoint was the proportion of subjects achieving Grade 0 or 1 in the facial wrinkle scale on maximum smile at Week 4. RESULTS: The primary endpoint was achieved by 72% of the subjects with HU-014 and onabotulinumtoxinA treatments, supporting the noninferiority of HU-014 compared with onabotulinumtoxinA. All secondary efficacy outcomes were achieved by the subjects. The 2 groups showed no significant differences in the safety analysis. CONCLUSION: HU-014 has noninferior efficacy and safety compared with onabotulinumtoxinA in the treatment of CFL.

Changes in skin characteristics after using respiratory protective equipment (medical masks and respirators) in the COVID-19 pandemic among healthcare workers.

BACKGROUND: The coronavirus disease-2019 (COVID-19) outbreak has presented unique dermatologic challenges due to respiratory protective equipment (RPE)-related skin conditions. OBJECTIVE: To objectively evaluate the effects of RPE including medical masks and respirators on the skin barrier by measuring various physiological properties of the skin. METHODS: A cross-sectional study was designed. Twenty healthy healthcare workers were included in this study. Skin parameters including skin hydration, transepidermal water loss (TEWL), erythema, sebum secretion, pH, and skin temperature were measured in the RPE-covered and RPE-uncovered areas of the face 4 and 8 hours after wearing RPE and 14 hours after not wearing RPE. RESULTS: Skin hydration, TEWL, erythema, pH, and skin temperature increased in the RPE-covered areas after wearing RPE for 4 and 8 hours. By contrast, in the RPE-uncovered areas, skin hydration decreased and TEWL, erythema, and pH showed minimal changes over time. Based on the repeated-measure analysis, the changes in skin physiological properties over time were significantly different between RPE-covered and RPE-uncovered areas. CONCLUSION: We observed that skin physiological characteristics change with the prolonged use of RPE such as medical masks and respirators. These changes may lead to various adverse skin reactions after long-term use.

Intralesional triamcinolone injections for the treatment of nail dystrophy: A case series.

Nail dystrophy can be temporary or permanent and affects quality of life for many patients. It can be secondary to an inflammatory condition; however, many cases are idiopathic. Despite many efforts, there is no promising treatment. Local steroid injection is one of the standard therapies offered for nail dystrophy, but there have been few formal open trials or case reports of its efficacy. This study investigated the impact of intralesional triamcinolone injections on the management and safety of nail dystrophy. Overall, 12 patients with 55 nails affected by nail dystrophy were enrolled. All lesions were injected with triamcinolone acetonide (2.5 mg/mL, 0.1 cc) through the proximal nail fold with a 30 g needle. Injections were administered every 4 weeks. Efficacy was retrospectively evaluated using physician's global assessment of clinical photographs graded on a 5-point scale as 0, no improvement; 1, slight improvement; 2, moderate improvement; 3, marked improvement; and 4, almost resolved. All adverse events that occurred during treatment were recorded. All patients presented with slight improvement of nail dystrophy after 1 to 3 months. The treatment durations varied from 6 to 12 months (mean, 8.58 months). The average time to observed therapeutic effect was 1.91 months after first treatment. The mean outcome assessment score was 2.8 points, with two patients each showing slight and moderate improvement and five showing marked improvement; in three, the dystrophy was almost resolved. Side effects of this regimen were minimal. Intralesional triamcinolone injections are an effective and safe method for the treatment of nail dystrophy.

Effects of hyaluronic acid injected using the mesogun injector with stamp-type microneedle on skin hydration.

The elasticity of the skin and its capacity to hold water decrease with aging because of the loss of hyaluronic acid (HA) in the skin. Therefore, there is an increasing interest in the use of HA fillers in skin rejuvenation beyond its conventional use which is supplementing decreased dermis volume and filling deep wrinkles. We investigated the efficacy and safety of a novel device (Dermashine balance) that injects HA into the dermis using a stamp-type microneedle for maintenance of hydration and elasticity of the skin. A single-center randomized double-blinded parallel-group clinical study was conducted, and 60 participants enrolled in this study. The subjects were randomized to receive HA injections or a placebo three times across the face using an automatic intradermal injector. At 4, 8, and 12 weeks after the treatment, skin hydration was measured using a corneometer. The patients who received HA showed significantly greater skin hydration than those who received the placebo. However, a significant difference was not noted in skin elasticity between the groups. No severe adverse event was reported. Intradermal supplementation of HA using mesogun multineedle injector may be a safe and effective treatment for improving skin hydration.

Gold nanoshell-mediated photothermal therapy for acne vulgaris.

Acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. Although the current treatment options are effective, they are associated with unwanted side effects, chronicity, relapses, and recurrences. Recently, the Food and Drug Administration approved topical application of gold microparticles for selective photothermolysis to treat acne vulgaris. Here, we report two cases showing the efficacy of gold nanoshell-mediated photothermal therapy for recurrent acne that were refractory to previous treatments. In both cases, three sessions of photothermal therapy prevented the development of new lesions during a follow-up period of 3-4 months without causing any adverse effects. The two cases reported here demonstrate the possibility of gold nanoshell-mediated photothermal therapy as a safe and effective treatment for recurrent acne vulgaris in Asian patients.

Successful Treatment of Pigmentary Disorders in Asians With a Novel 730-nm Picosecond Laser.

BACKGROUND AND OBJECTIVE: Until recently, quality-switched nanosecond lasers have been the workhorse lasers in treating pigmented lesions. However, the recently commercialized picosecond lasers have provided physicians with a novel method to manage pigmented lesions. Most recently, the first picosecond laser with a 730-nm wavelength was developed to specifically target melanin and melanocytes. STUDY DESIGN/MATERIALS AND METHODS: We report on two Asian patients with freckles, lentigines, and melasma who were successfully treated with a novel 730-nm Ti:Sapphire picosecond laser (Picoway®; Syneron Candela, Corp). The clinical outcome was measured by the global percent of clearance, which was evaluated by blinded observers by comparing the post-treatment photographs with the baseline photographs. RESULTS: In both patients, a significant pigmentary reduction was achieved with only one treatment session. In both patients, the treatments were well tolerated with minimal discomfort even without topical anesthesia. No post-inflammatory hyperpigmentation or repigmentation was observed until the 6-week follow-up. The pigmentary conditions treated included freckles, lentigines, and melasma. Both subjects showed clinical improvement, with the best results observed for the treatment of freckles such that 95% of the lesions achieved excellent response (75-94% lightening). CONCLUSION: The results of this case report indicate that a novel 730-nm Ti:Sapphire picosecond laser may be effective and safe in treating pigmentary disorders in darker-skinned patients. Therefore, further well-designed, prospective clinical trials are warranted to establish the potential of 730-nm picosecond lasers and determine the optimal treatment parameters in comparison to existing laser and light modalities. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Potency and Quality of Reconstituted Botulinum Neurotoxin Type A According to Storage Temperatures.

BACKGROUND: In clinical practice, one of the most important issues regarding the use of botulinum neurotoxin A (BoNT-A) is the proper storage conditions and the change in potency and quality over time after reconstitution. OBJECTIVE: This study aimed to investigate the change in potency and quality of reconstituted prabotulinumtoxin A (PraBoNT-A) over time when stored at different storage temperatures. MATERIALS AND METHODS: ICR/CD-1 mice and PraBoNT-A were used for the mouse intraperitoneal lethal dose 50% (LD50) test. A thorough quality evaluation of the product was performed. RESULTS: All of the reconstituted PraBoNT-A stored at different temperatures met the evaluation criteria for the suggested limits of estimated potency and for the quality assessment at every evaluated time point. When the stability of reconstituted PraBoNT-A was evaluated by regression analysis, the shelf life of reconstituted PraBoNT-A was found to be 99.24, 73.80, and 16.34 weeks in the case of PraBoNT-A stored at freezing, refrigeration, or room temperatures, respectively. CONCLUSION: Based on the results, the authors conclude that the efficacy and quality of the reconstituted PraBoNT-A product are not compromised at least for a certain period of time and that the shelf life of reconstituted PraBoNT-A is longest when stored at the freezing temperature.

Bereaved families are still embittered after the Sewol ferry accident in Korea: A follow-up study 18 and 30months after the disaster.

INTRODUCTION: The Sewol ferry accident that occurred in April 2014 was one of the most tragic human-made disasters in Korean history. Due to the deaths of hundreds of children, bereaved families likely feel embittered; however, there is little extant research documenting embitterment among those who experienced the disaster. Consequently, we investigated bereaved family members' embitterment and other psychiatric symptoms 18months and 30months after the disaster. METHODS: Data from a cross-sectional survey were obtained 18months (Time 1) and 30months (Time 2) after the disaster. We ascertained socio-demographic variables and variables obtained from a self-reporting questionnaire (i.e., depression, anxiety, posttraumatic stress disorder, complicated grief, and embitterment) among 56 bereaved family members. RESULTS: Bereaved families showed substantial embitterment at Time 1 (64.3%), which increased at Time 2 (76.8%, t=1.761, p=0.084). The participants who displayed increased embitterment at Time 2 also increased in anxiety, post-traumatic stress symptoms, and complicated grief (but not depression). Furthermore, participants who displayed decreased embitterment at Time 2 also decreased in all other psychiatric symptoms. (time×group interaction in depression (F 0.644, p=0.426), anxiety (F 4.970, p=0.030), PTSD (F 10.699, p=0.002), and complicated grief (F 8.389, p=0.005)). CONCLUSIONS: Embitterment of bereaved families had not ceased after 18months and even increased 1year later. Additionally, as embitterment increased, many other psychiatric symptoms also increased, and vice versa. Our results suggest that embitterment is associated or can even influence other psychiatric symptoms; therefore, embitterment should be examined after disasters.