RESUMO
AP collagen peptides (APCPs) are enzymatically decomposed collagen peptides that contain tri-peptides such as glycine-proline-hydroxyproline. We found that APCPs increased the proliferation of both human dermal papilla cells (hDPCs) and human outer root sheath cells (hORSCs). APCPs also stimulated the secretion of several growth factors, including IGFBP-6, PDGF-AB, PIGF and VEGF in hDPCs. Moreover, APCPs enhanced the phosphorylation of Akt(Ser473), GSK-3ß(Ser9) and ß-catenin(Ser675), indicating the activation of the GSK-3ß/ß-catenin signalling pathway. Ex vivo culture of human hair follicles (hHFs) tissue and in vivo patch assay revealed that APCPs promoted the elongation of hHFs and the induction of new hair shafts. In a mouse model, APCPs significantly promoted the transition from telogen to anagen phase and prolonged anagen phase, resulting in increased hair growth. APCPs also improved the thickness, amino acid content (cystine and methionine) and roughness of mouse hair. Taken together, these findings demonstrate that APCPs accelerate hair growth and contribute to overall hair health. Therefore, APCPs have the potential to be utilized as a food supplement and ingredient for preventing hair loss and maintaining hair health.
Assuntos
Glicogênio Sintase Quinase 3 beta , Folículo Piloso , Cabelo , beta Catenina , Animais , Glicogênio Sintase Quinase 3 beta/metabolismo , beta Catenina/metabolismo , Humanos , Camundongos , Cabelo/crescimento & desenvolvimento , Cabelo/efeitos dos fármacos , Folículo Piloso/metabolismo , Folículo Piloso/crescimento & desenvolvimento , Proliferação de Células/efeitos dos fármacos , Transdução de Sinais , Colágeno/metabolismo , Fosforilação , Células Cultivadas , Peptídeos/farmacologiaRESUMO
Atopic dermatitis (AD) is a chronic inflammatory skin disease. Skin barrier dysfunction is the initial step in the development of AD. Recently, exosomes have been considered as potential cell-free medicine for skin defects such as aging, psoriasis and wounds. The aim of this study was to investigate the effects of human dermal fibroblast-neonatal-derived exosome (HDFn-Ex) on AD. HDFn-Ex increased the expression of peroxisome proliferator activated receptor α (PPARα) and alleviated the 1-chloro-2,4-dinitrobenzene (DNCB)-mediated downregulation of filaggrin, involucrin, loricrin, hyaluronic acid synthase 1 (HAS1) and HAS2 in human keratinocyte HaCaT cells. However, these effects were inhibited by the PPARα antagonist GW6471. In the artificial skin model, HDFn-Ex significantly inhibited DNCB-induced epidermal hyperplasia and the decrease in filaggrin and HAS1 levels via a PPARα. In the DNCB-induced AD-like mouse model, HDFn-Ex administration reduced epidermis thickening and mast cell infiltration into the dermis compared to DNCB treatment. Moreover, the decreases in PPARα, filaggrin and HAS1 expression, as well as the increases in IgE and IL4 levels induced by DNCB treatment were reversed by HDFn-Ex. These effects were blocked by pre-treatment with GW6471. Furthermore, HDFn-Ex exhibited an anti-inflammatory effect by inhibiting the DNCB-induced increases in IκBα phosphorylation and TNF-α expression. Collectively, HDFn-Ex exhibited a protective effect on AD. Notably, these effects were regulated by PPARα. Based on our results, we suggest that HDFn-Ex is a potential candidate for treating AD by recovering skin barrier dysfunction and exhibiting anti-inflammatory activity.
Assuntos
Dermatite Atópica , Exossomos , Dermatopatias , Animais , Camundongos , Recém-Nascido , Humanos , Dermatite Atópica/induzido quimicamente , Dermatite Atópica/tratamento farmacológico , Dermatite Atópica/metabolismo , PPAR alfa/metabolismo , Dinitroclorobenzeno/metabolismo , Dinitroclorobenzeno/farmacologia , Dinitroclorobenzeno/uso terapêutico , Proteínas Filagrinas , Dinitrobenzenos/efeitos adversos , Dinitrobenzenos/metabolismo , Exossomos/metabolismo , Pele/metabolismo , Anti-Inflamatórios/farmacologia , Dermatopatias/metabolismo , Citocinas/metabolismo , Camundongos Endogâmicos BALB CRESUMO
BACKGROUND: With the continuous increasing availability of new filler products, each hyaluronic acid filler brand has distinctive pharmacokinetics, which may be associated with different complications. Therefore, the long-term safety of new generations of fillers should be evaluated. OBJECTIVE: This prospective, multicenter, observational, postmarketing study ( ClinicalTrials.gov identifier: NCT04738019) aimed to investigate the incidence of delayed-onset nodules and adverse reactions after the injection of new hyaluronic acid fillers (YYS series) into the facial skin. METHODS: Subjects scheduled to receive an injection YYS series filler were followed up for 52 weeks. The authors aimed to determine the incidence of a self-reported delayed-onset nodule-a visible or palpable nodule or mass at the injection site that was detected beyond the 14th day following the injection-during the 1-year follow-up period. RESULTS: Among the 1,022 subjects who received an injection of the YYS series, the incidences of delayed-onset nodules were 0% for YYS 360, YYS 540, and YYS 720. A 0.21% incidence (1 delayed hypersensitivity reaction) of a delayed-onset adverse reaction was noted for YYS 720, although none were reported for YYS 360 and YYS 540. CONCLUSION: In this study, a notably low frequency of adverse reactions associated with the YYS series was observed.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Ácido Hialurônico , Humanos , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/administração & dosagem , Estudos Prospectivos , Feminino , Preenchedores Dérmicos/efeitos adversos , Preenchedores Dérmicos/administração & dosagem , Pessoa de Meia-Idade , Masculino , Adulto , Técnicas Cosméticas/efeitos adversos , Vigilância de Produtos Comercializados/estatística & dados numéricos , Idoso , Reação no Local da Injeção/epidemiologia , Reação no Local da Injeção/etiologia , Seguimentos , FaceRESUMO
BACKGROUND: Despite the widespread use of botulinum toxin (BTX) injection for the treatment of masseter muscle hypertrophy (MMH), there is no standard treatment option. OBJECTIVE: We report the efficacy and safety for BTX in MMH over a period of 48 weeks. METHODS: In double-blinded, placebo-controlled phase 3 trials, 180 patients (randomized 1:1) received treatment with placebo (normal saline) or prabotulinumtoxinA (48 units). Masseter muscle thickness (at maximal clenching and resting positions), 3D imaging analysis, and masseter muscle hypertrophy scale grades were analyzed at each time point. After the 24-week CORE study, all patients who met the same criteria of the CORE study at week 24 ( n = 114) received only prabotulinumtoxinA, regardless of previous treatment, for an additional 24 weeks (48 weeks in total) for the open-label extension study. RESULTS: The largest differences in mean and percent changes from baseline in masseter muscle thickness were observed at 12 weeks, and there were significant differences between the 2 groups at all time points (all p < .001). The effect was independent of the number of injections. No serious adverse event was observed. CONCLUSION: PrabotulinumtoxinA could effectively ameliorate MMH without major complications.
Assuntos
Toxinas Botulínicas Tipo A , Hipertrofia , Músculo Masseter , Humanos , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Hipertrofia/tratamento farmacológico , Músculo Masseter/efeitos dos fármacos , Músculo Masseter/patologia , Músculo Masseter/anormalidades , Feminino , Pessoa de Meia-Idade , Adulto , Masculino , Resultado do Tratamento , Fármacos Neuromusculares/administração & dosagem , Fármacos Neuromusculares/efeitos adversos , Injeções IntramuscularesRESUMO
BACKGROUND: The process of hair dyeing causes hair damage, and periodic re-dyeing is required for newly grown hair. To avoid these hassles, hair color shampoos have been developed and are widely used. In this study, we compared the effects of two hair color shampoos with different dyeing principles to analyze the function of hair color shampoos. We analyzed hair tresses treated by hair-oxidation- and hair-coating-based shampoos. MATERIALS AND METHODS: We measured the color, tensile properties, softness, elasticity, gloss, moisture content, and protein content of the hair tresses dyed with color shampoos. The hair structures were analyzed by scanning and transmission electron microscopies (SEM and TEM) and a hydroxy radical-based method. RESULTS: The shampoo based on hair coating enhanced the hair dyeing effect and roughness, whereas that based on hair oxidation improved the color retention and moisture content in the hair tresses. Frictional resistance, gloss, and elasticity of the hair tresses were similar for the two products. However, according to the results of the protein loss test, TEM, and hydroxyl radical staining, the shampoo based on hair oxidation showed a longer dyeing retention compared to that based on hair coating but caused cuticle damage. CONCLUSION: These results show that the two shampoos with different dyeing principles exhibit different hair dyeing abilities and hair health indices. Therefore, we recommend that hair color shampoos should be used according to the requirements of an individual.
Assuntos
Preparações para Cabelo , Humanos , Preparações para Cabelo/farmacologia , Corantes/análise , Cabelo/química , Proteínas/metabolismoRESUMO
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.
Assuntos
Rejuvenescimento , Envelhecimento da Pele , Humanos , Pele , Epiderme , Derme , ColágenoRESUMO
Polycaprolactone (PCL)-based fillers are widely used for skin rejuvenation and wrinkle reduction. The objective of this study is to compare the efficacy and safety of newly developed PCL-based fillers (SYB filler®; SF-01) and widely used existing PCL-based fillers (Ellansé-M®) for correction of moderate-to-severe nasolabial folds. In a randomized, participant-and evaluator-blinded, matched-pair, prospective study, participants were randomized for injections of SF-01 or Ellansé-M® in both nasolabial folds. Efficacy was evaluated using the Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS), and a three-dimensional (3D) scanner. All adverse events (AEs) were examined and reported. At month 12, both SF-01-and Ellansé-M®-treated groups showed statistically significant improvements in the WSRS, GAIS, and 3D scanner scores compared to baseline. The difference in changes in WSRS scores at month 12 between the two groups was 0.08 ± 0.34 compared to baseline. The upper limit of the 95.0% confidence interval was 0.0031, which was lower than the predefined margin for non-inferiority (0.35). All AEs were injection site-related (swelling, pain, and erythema) and disappeared within 30 min after the procedure. SF-01 was non-inferior to Ellansé-M® and demonstrated favorable efficacy and safety at 12 months after correcting moderate-to-severe nasolabial folds.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Humanos , Ácido Hialurônico , Sulco Nasogeniano , Poliésteres , Estudos Prospectivos , Resultado do TratamentoRESUMO
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.
Assuntos
Técnicas Cosméticas , Envelhecimento da Pele , Face , Humanos , Estudos Prospectivos , Resultado do TratamentoRESUMO
Excessive accumulation of submental fat (SMF) causes a lower face cosmetic problem. A lipolytic injectable has recently been developed as a solution. The objective of this study is to investigate the effects and safety of DWJ211 (a newly developed lipolytic injectable) in the reduction of SMF and to identify the optimum dose. In this multi-center, double-blind, placebo-controlled study, subjects with moderate to severe SMF were randomized to injections of DWJ211 0.5%, DWJ211 1%, DWJ211 2% or placebo in the submental area, every 4 weeks, up to Week 12. Efficacy was determined by improvements in physician-assisted SMF rating scales (PA-SMFRS) and subject-assisted SMF rating scales (SA-SMFRS) 4 weeks after the last treatment (Week 16). Safety was assessed by inquiries, subject diary entries of adverse events, laboratory tests, and vital sign checks. Of 140 enrolled subjects, 136 were included in the analysis. The proportions of subjects, who achieved ≥1-grade improvement on the PA-SMFRS were 41.7%, 65.7%, 84.4%, and 72.7%, and the proportions of subjects, who achieved ≥1-grade improvement on the SA-SMFRS were 50.0%, 71.4%, 93.8%, and 81.8% for the placebo, DWJ211 0.5%, DWJ211 1%, and DWJ211 2% group, respectively. Adverse drug reactions (ADRs) were more common in each of the treatment groups compared with placebo, with the most common ADR being injection site pain. No subjects experienced any serious adverse events. In conclusion, the 1% DWJ211 dose was beneficial for SMF reduction and had a tolerable safety profile. Thus, we selected 1% as the dose to be tested in a Phase 3 clinical trial.
Assuntos
Ácido Desoxicólico , Gordura Subcutânea , Método Duplo-Cego , Humanos , Injeções Subcutâneas , Satisfação do Paciente , Resultado do TratamentoRESUMO
Various treatment methods are used for noninvasive body contouring. To evaluate the efficacy and safety of a newly designed cryolipolysis device using a three-dimensional cooling method for abdominal fat reduction. Twenty-five participants with clinically apparent abdominal fat tissue participated in the study. The thickness of fat tissue below the umbilicus level was measured using a caliper at baseline and 12 weeks after the first treatment. The height of abdominal subcutaneous fat tissue on ultrasonography and participant satisfaction were assessed at every visit for 16 weeks. All adverse events (AEs) during the study period were recorded. p values <0.05 were considered statistically significant. Twenty-four participants completed this study; the mean BMI of participants was 29.34 ± 2.36 kg/m2 . The mean thickness of abdominal subcutaneous fat was significantly lower at 12 weeks (40.4 ± 6.8 mm, p < 0.001) than at baseline (49.3 ± 8.5 mm). Differences in the height of abdominal subcutaneous fat compared to that at baseline were 1.02 ± 0.41 cm (12 weeks, p < 0.001) and 1.13 ± 0.44 cm (16 weeks, p < 0.001). Rates of abdominal subcutaneous fat reduction at 12 and 16 weeks compared to that at baseline were 28.45% and 31.13%, respectively. The ratio of abdominal circumference to hip circumference at 12 and 16 weeks was significantly decreased compared to that at baseline. Most participants (95.8%) reported improvement in satisfaction scores at 16 weeks. There were no serious AEs during the entire study period. The study demonstrated the efficacy of a noninvasive cryolipolysis device using a three-dimensional cooling method for reducing abdominal subcutaneous fat.
Assuntos
Contorno Corporal , Lipectomia , Contorno Corporal/efeitos adversos , Contorno Corporal/métodos , Humanos , Lipectomia/efeitos adversos , Lipectomia/métodos , Satisfação do Paciente , Estudos Prospectivos , Gordura Subcutânea Abdominal/diagnóstico por imagem , Gordura Subcutânea Abdominal/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Assessing the area involved in a skin disease, i.e. the body surface area (BSA), is essential in diagnosing disease severity, including in psoriasis. However, in psoriasis, BSA tends to be overestimated by physicians and has shown high inter-rater and intrarater variability. Furthermore, there are no reports suggesting the cause and clinical significance of overestimating BSA in psoriasiss. AIM: To investigate the errors in estimating BSA in psoriasis by comparing physicians' results with those of computer-assisted image analysis (CAIA) and to provide suggestions regarding the clinical implications of such errors. METHODS: Using 43 images, 36 physicians visually estimated BSA in psoriasis, and subsequently, the images were evaluated using a CAIA program (ImageJ); the BSA values determined by the physicians and CAIA were then compared and matched. The BSA percentage was also graded on a scale from 0 to 6, as follows: Grade 0 = no lesion, Grade 1 = 1%-9%, Grade 2 = 10%-29%, Grade 3 = 30%-49%, Grade 4 = 50%-69%, Grade 5 = 70%-89% and Grade 6 = 90%-100%. Each grade range was divided, with the bottom and top 50% defined as the 'first half' and 'second half,' respectively. RESULTS: The mean proportion of correct assessments by physicians was 49.4%. Physicians tended to overestimate the BSA of psoriatic lesions by 8.76% ± 8.82% compared with CAIA. The largest estimation error (proportion incorrect 75.7%) was observed in Grade 3 (30%-49% involvement). Estimates in the second half of the range demonstrated a higher proportion of inaccuracies compared with those in the first half. An overestimating error occurred in certain morphological characteristics of the psoriatic lesions. CONCLUSIONS: The inaccuracy of BSA estimation by physicians may be related to the fact that information from the human eye is perceived to be exaggerated compared with the actual size. Further research into using artificial intelligence technology is needed to reduce quantification error and develop an ideal BSA assessment system. Additionally, education and training are needed for physicians to measure BSA accurately.
Assuntos
Médicos , Psoríase , Inteligência Artificial , Superfície Corporal , Humanos , Processamento de Imagem Assistida por Computador/métodos , Psoríase/diagnóstico , Psoríase/patologia , Reprodutibilidade dos Testes , Índice de Gravidade de DoençaRESUMO
PURPOSE: The purpose of this study is to evaluate the efficacy and safety of treating lower eyelid fat bulging with ultrasound-assisted lipolysis (UAL) by performing a preclinical evaluation of the procedure on a Yorkshire pig. METHODS: Two white Yorkshire pigs had lower eyelid fat bulging treated with UAL using a probe with a diameter of 1.0 mm or less. Fourteen days after treatment, we evaluated the changes in fat thickness from ultrasound, changes in skin contour (volume and height) from the Antera 3D™, and the disruption of fat cells and changes in collagen synthesis from histological evaluation. RESULTS: Fourteen days after treatment, the fat layer was significantly reduced with no damage to the skin surface. The mean change in the subcutaneous fat layer thickness was decreased 1.51-0.75 mm in ultrasound analysis. The skin contour of the treated area also decreased with time from 202.5 to 163.5 mm in mean volume and 0.8111 to 0.646 mm in mean height. Masson's trichrome staining showed that the UAL treatment induced the regeneration and remodeling of collagen. CONCLUSION: The results of this study demonstrate that UAL successfully reduced the bulging lower eyelid fat of a Yorkshire pig and also increased collagen contraction to tighten skin. UAL may be a beneficial and well-tolerated treatment option for lower eyelid fat bulging.
Assuntos
Lipectomia , Adipócitos , Animais , Pálpebras/diagnóstico por imagem , Lipólise , Suínos , UltrassonografiaRESUMO
BACKGROUND: Non-invasive body-sculpting procedures are becoming increasingly popular. The application of 1,060 nm of laser energy transcutaneously to hyperthermically induce the disruption of fat cells in the abdomen is a type of non-invasive procedure. AIMS: The purpose of this study was to compare the treatment results from two parameters of the same system, each with different energy output levels, in an in vivo porcine model to determine the most effective application. METHODS: Female pigs (n = 3) were used in this study. We examined the effects of the treatment using photography, ultrasonography, gross and microscopic pathology, and histological examination in order to determine the mechanism of action, efficacy, and safety of the procedure. Blood chemistry analysis was performed before each session to check lipid levels and to monitor for any adverse changes in markers that may indicate liver damage. Biopsies were taken and routinely processed with hematoxylin and eosin and Oil Red O stains to examine for tissue damage at baseline and after each treatment. Terminal deoxynucleotidyl transferase deoxyuridine triphosphate nick end labeling (TUNEL) assays were performed to check for apoptotic-related DNA damage. RESULTS: Ultrasonic imaging of the same area before and after the application of 1,060 nm of laser energy at outputs of 0.9 and 1.4 W/cm2 showed that the density of the fat layer changed immediately after irradiation due to the transient heat transfer in the fat layer. Preclinical evaluation was performed to obtain comparison data on the safety and efficacy of subcutaneous fat reduction after applying the different energy outputs of 0.9 and 1.4 W/cm2 . CONCLUSION: Based on our findings, we suggest that long-term histologic changes through the use of these devices suggest a comparative effectiveness of the treatment energy.
Assuntos
Lasers de Estado Sólido , Lipectomia , Adipócitos , Animais , Feminino , Lipólise , Gordura Subcutânea/diagnóstico por imagem , SuínosRESUMO
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.
Assuntos
Envelhecimento da Pele , Pele , Administração Tópica , Diagnóstico por Imagem , Humanos , Imageamento Tridimensional , Unhas/diagnóstico por imagem , Pele/diagnóstico por imagem , Propriedades de SuperfícieRESUMO
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.
Assuntos
Toxinas Botulínicas Tipo A/uso terapêutico , Satisfação do Paciente , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Recently, the safety of a new botulinum toxin (HU-014) was confirmed through animal experiments. The evaluation of the efficacy and safety of this newly introduced botulinum toxin is required considering the risk of adverse events (AEs) and need for standardization before its universal use. OBJECTIVE: The aim of this multicenter, double-blind, randomized, parallel, active-controlled phase III clinical trial was to investigate the noninferiority of HU-014 versus existing onabotulinumtoxin A for the treatment of moderate to severe glabellar lines. METHODS: In total, 267 subjects were randomized to either the test (HU-014) or control (onabotulinumtoxin A) group. At the baseline and at weeks 4, 8, 12, and 16, investigator's live assessment, independent photographic assessment, subjects' improvement assessment, subjects' satisfaction assessment, and safety assessment were performed. RESULTS: At week 4, the response rate was 90.15% and 92.31% in the test and control groups, respectively, as per investigator's live assessment while frowning, without a significant difference. Both groups also showed no significant differences in response rates in the other assessments. In addition, no serious AEs were reported. CONCLUSION: HU-014 was noninferior to existing onabotulinumtoxin A in the treatment of glabellar lines at a 1:1 dose ratio, and both products were well tolerated.
Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Técnicas Cosméticas , Fármacos Neuromusculares/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Face , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos , Adulto JovemRESUMO
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.
RESUMO
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.
Assuntos
Técnicas Cosméticas , Envelhecimento da Pele , Técnicas Cosméticas/efeitos adversos , Humanos , Ácido Hialurônico/efeitos adversos , Agulhas , Rejuvenescimento , PeleRESUMO
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.
Assuntos
Doenças da Unha , Unhas Malformadas , Psoríase , Humanos , Injeções Intralesionais , Doenças da Unha/tratamento farmacológico , Psoríase/tratamento farmacológico , Qualidade de Vida , Estudos Retrospectivos , Resultado do Tratamento , Triancinolona Acetonida/efeitos adversosRESUMO
BACKGROUND: Essential oil derived from Chamaecyparis obtusa (EOCO) has been used as an alternative treatment for allergy-related diseases due to its immune-modulating characteristics. Clothing has the longest and most intense contact with human skin, and functional fabrics with intrinsic properties have been increasingly implemented in medical applications. Specially designed fabrics may support atopic dermatitis (AD) treatment. In this study, the effects of fabric containing EOCO on AD were investigated using an NC/Nga mouse model. METHODS: The fabric was applied for 6 h per day for 14 days. The therapeutic effects were evaluated according to measurements of skin lesion severity (modified SCORAD score), transepidermal water loss (TEWL), serum IgE and inflammatory cytokine levels, lesion thickness measured after hematoxylin and eosin staining, and immunohistochemical and Western blot analysis for skin epidermal differentiation protein. RESULTS: The EOCO group exhibited significantly reduced modified SCORAD score, TEWL, and serum IgE levels. Among the inflammatory cytokines analyzed, only the mean values of regulated on activation, normal T cell expressed and secreted were observed to be decreased compared with other control groups. The histological analysis of the skin also revealed that the EOCO group expressed reduced epidermal hyperplasia and recovered filaggrin, involucrin, and loricrin expression. CONCLUSIONS: It was confirmed that fabric containing EOCO has anti-atopic and anti-inflammatory properties. The study data show that fabric containing EOCO can be implemented as an alternative functional clothing for people suffering from AD.