Rheological properties and preclinical data of novel hyaluronic acid filler containing epidermal growth factor.

Recently, a novel hyaluronic acid (HA) filler containing the epidermal growth factor (EGF) was developed. The objective of this study was to evaluate the rheological properties, preclinical efficacy and biocompatibility of the EGF-containing HA filler (HA-EGF filler) using a photoaged mouse model. The rheological properties of the new HA-EGF filler were assessed. Twenty-four female hairless mice (SKH1) underwent photoaging induction with 8 weeks of ultraviolet-B irradiation. The mice were randomly divided into four groups and intradermally injected 100 µl of phosphate-buffered saline, HA-EGF filler, HA filler or polynucleotide (PN) into the dorsal region. We examined the effect of fillers on photoaged skin by dermoscopic examination. Furthermore, histological evaluation with immunohistochemical staining was performed to determine the biocompatibility and collagen formation at the 10th week. A real-time quantitative polymerase chain reaction analysis and western blot test assessed the expression of collagen I/III, matrix metalloproteinases (MMPs) and transforming growth factor. The viscosity and elasticity of the HA-EGF filler were lower than those of the HA filler. Histological evaluation revealed no significant differences in the collagen synthesis between the HA-EGF, HA and PN filler groups. No inflammation was observed during the experimental period. The HA-EGF filler induced type I/III collagen production and downregulated the expression of MMP-1, 3 and 9. Our results suggest that the novel HA-EGF filler may be an additional therapeutic option for photoaged skin, which works by inducing collagen synthesis. Based on these preclinical results, further well-controlled clinical studies are required.

Treatment of facial pigmented disorders with a 785-nm picosecond Ti:sapphire laser in Asians: A report of three cases.

Since the advent of the theory of selective photothermolysis, the importance of targeting the chromophore and minimizing the surrounding damage has been extensively discussed. Picosecond-domain laser (ps-laser) treatment with a wide range of wavelengths is an emerging option for various pigmented lesions; however, no definitive treatment choice has been confirmed. The authors aimed to investigate the efficacy and safety of a ps-laser with a 785-nm wavelength for the treatment of facial pigmented lesions in Asians. Three Korean patients with facial pigmented lesions were recruited for the study. A 785-nm ps-laser with a fractionated and an unfractionated handpiece was utilized to administer the treatment. The clinical outcome was evaluated by a clinician by comparing pre- and post-treatment photographs. All patients exhibited a significant improvement in pigmented lesions including freckles, lentigines, and melasma, after three to four sessions of treatment. No adverse events, including post-inflammatory hyperpigmentation or hypopigmentation were observed. In conclusion, this novel 785-nm Ti:sapphire ps-laser may be an effective and safe modality for treating pigmented lesions in skin of color.

Evaluation of the efficacy and safety of the 1064 nm picosecond Nd:YAG laser with a topically applied gold and diamond suspension for facial skin rejuvenation: A pilot study.

To investigate the efficacy and safety of combined treatment with a serum comprising a micro-diamond suspension and micro-gold cage with a 1064 nm picosecond neodymium-doped yttrium aluminum garnet (Nd:YAG) laser for facial skin rejuvenation. Topical serum was applied to the entire face and allowed to penetrate the skin and hair follicles for 20 min. Each participant was then treated with a 1064 nm picosecond Nd:YAG laser on the face. Photographs of each participant were taken at baseline, immediately after treatment, and 2 weeks after treatment using an imaging tool (Mark-Vu®; PSI PLUS, Suwon, Republic of Korea). Global improvement scores by two blinded investigators and participants' satisfaction scores were also assessed. The melanin index (MI), transepidermal water loss (TEWL), and skin hydration were evaluated using a device. Parameters associated with skin rejuvenation were assessed using Mark-Vu®. Adverse events were observed and reported by participants and physicians during the treatment and follow-up visit. At week 2, 40% (4/10) of the participants showed more than moderate clinical improvement in the investigator's global improvement assessment. No significant differences were observed in the MI, TEWL, skin hydration level, or skin parameters of Mark-Vu®. At week 2, 40% of the participants reported a high satisfaction score and minimal side effects. The novel topical facial serum comprising micro-diamond suspension and micro-gold cage is safe and effective when combined with laser treatment for facial rejuvenation.

Validation of Relationship between Patients' Descriptions of Pruritus and Patient-burden of Chronic Pruritus using Structural Equation Modelling.

Patients with chronic itch describe their pruritus in a wide variety of ways. However, these subjective descriptions are often not taken into consideration by physicians. This study aimed to validate patients' descriptions of pruritus, and to investigate the relationship between various descriptions of pruritus and the patient burden of chronic pruritus by examining the mediating effects of sleep disturbance and sexual dysfunction on patient's quality of life, as predicted by various descriptions of pruritus. Exploratory and confirmatory factor analyses were performed to identify the factor structure measured by 11 descriptions of pruritus. The study then analysed differences in the degree of sleep disturbance, sexual dysfunction, and quality of life deterioration factors using a structural equation modelling method. Using data from 419 patients with chronic pruritus, 11 descriptions of pruritus were classified into 2 groups: (i) sensory pruritus (i.e. stinging, stabbing, burning, painful, formication, throbbing, and cold) that are linked with descriptions of pruritus patterns; and (ii) affective pruritus (i.e. annoying, unbearable, worrisome, and warm) from patient reports of psychological or emotional distress. The study found that affective pruritus decreases patient's quality of life either directly or indirectly through sleep disturbance. In conclusion, clues about a patients' sleep disturbance or poor quality of life can be obtained through their descriptions of pruritus.

Estimation error of the body surface area in psoriasis: a comparative study of physician and computer-assisted image analysis (ImageJ).

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.

In vivo evaluation of novel particle-free polycaprolactone fillers for safety, degradation, and neocollagenesis in a rat model.

Dermal fillers have become popular due to the increased demand for skin rejuvenation products. Polycaprolactone (PCL), a newly developed bioresorbable medical polymer, has emerged as a durable and safe dermal filler. However, available PCL fillers cause irritation; carrier gels can coagulate PCL particles, block the injection needle, and cause nonhomogeneity of particle suspensions that could be responsible for the observed side effects. To relieve pain, premixing PCL filler with lidocaine. However, this formulation changes the property of the CMC portion of the PCL filler, and possibly results in an uneven suspension of the PCL particles. Hence, a particle-free PCL homogeneously solubilized in water was developed to overcome these limitations. This study aimed to assess the in vivo safety, biodegradability, and neocollagenesis ability of a novel PCL filler, DLMR01 using a rat model. Fillers were characterized after injecting a vehicle control or DLMR01 using a digital camera, folliscope, and a three-dimensional profiling system. Biopsy was performed to evaluate biocompatibility and neocollagenesis. Skin elasticity was measured using a Cutometer. DLMR01 caused no needle occlusion by particle aggregation or laborious injectability. Filler nodules dispersed to surrounding tissues within 6 hours without further granuloma formation. Histological inspection revealed no tissue residual material or foreign body reaction during the 12-week test period. DLMR01 increased dermal thickness, collagen regeneration, and skin elasticity. In conclusion, this study demonstrates the potential of DLMR01 for dermal rejuvenation in a rat model.

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.

Efficacy and Safety of a Novel Botulinum Toxin A for Masseter Reduction: A Randomized, Double-Blind, Placebo-Controlled, Optimal Dose-Finding Study.

BACKGROUND: A wide lower face and a square jaw are considered esthetic problems, particularly in Asia. OBJECTIVE: To investigate the optimal dose of a novel botulinum toxin (prabotulinum toxin A) for treating masseteric hypertrophy. METHODS: Ninety subjects with masseteric hypertrophy were randomly divided into 5 groups and treated with placebo (A, normal saline) or prabotulinum toxin A (B: 24, C: 48, D: 72, and E: 96 units). Photography, ultrasonography, and 3-dimensional imaging were performed before and after injection at baseline and at 4, 8, 12, and 16 weeks after treatment. The participants also rated their satisfaction. RESULTS: Masseter thickness significantly reduced in all groups at 12 weeks, compared with that in the placebo group. A dose-dependent reduction in masseter thickness was observed at the resting and maximal clenching positions. Sonography and 3-dimensional imaging revealed a gradual reduction in masseter thickness and volume, respectively, during the first 12 weeks. Despite being slightly effective, a dose of 24 units might be insufficient for resolving square face problems. Patients in Group E reported discomfort during jaw movement. CONCLUSION: Prabotulinum toxin A could effectively improve lower face contour without major complications, with an optimal dose of 48 to 72 units, followed by reinjection after 12 weeks.

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 Electrocoagulation With Insulated Microneedle for the Treatment of Periorbital Syringomas: A Retrospective Analysis.

BACKGROUND: Conventional treatment options for periorbital syringomas are often unsatisfactory because of inevitable surface damage from the procedure and frequent recurrence rate of the tumors. OBJECTIVES: The authors sought to ascertain the efficacy and safety of intralesional electrosurgery utilizing a monopolar radiofrequency device with a single insulated microneedle for the treatment of periorbital syringomas. METHODS: A retrospective analysis was performed employing data from medical records, routine questionnaires, and clinical photographs of 55 patients with periorbital syringoma who underwent intralesional electrosurgery. RESULTS: Approximately one-half of the patients (50.9%) experienced marked resolution after 1 treatment. The lesion clearance rate increased and lesion severity decreased each time the treatment was repeated. No persistent therapy-related adverse event was found except transient erythema or crusting. CONCLUSIONS: Intralesional electrosurgery with insulated microneedle is an effective and safe treatment option for periorbital syringomas.

Validity and reliability of itch assessment scales for chronic pruritus in adults: A prospective multicenter study.

BACKGROUND: Several tools can provide a reliable and accurate evaluation of pruritus, including the visual analog scale (VAS), numeric rating scale (NRS), verbal rating scale (VRS), and multidimensional questionnaires such as the Itch Severity Scale (ISS). However, no single method is considered a gold standard. OBJECTIVE: We evaluated the validity and reliability of VAS, NRS, VRS, and ISS and their correlation with a pruritus-specific quality of life instrument, ItchyQoL. METHODS: A total of 419 patients (215 men and 204 women) with chronic pruritus (mean age, 46.58 years) recorded their pruritus intensity on VAS, NRS, VRS, and ISS. Retest reliability was analyzed in a second assessment 3 hours after the initial assessment. All participants answered ItchyQoL. RESULTS: A strong correlation between VAS, NRS, and VRS was found. ISS showed a low intercorrelation validity with these tools. However, ISS was more strongly correlated with ItchyQoL. The retest reliability scores were similar for VAS, NRS, and VRS but lower than the scores obtained for ISS. LIMITATIONS: Limitations include patient heterogeneity and recall bias. CONCLUSION: The assessment of pruritus is challenging because of the subjective symptoms and the multifactorial nature. Therefore, more studies are needed to determine the best strategy to assess itch intensity.

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.

Selective Sebaceous Gland Electrothermolysis Using a Single Microneedle Radiofrequency Device for Acne Patients: A Prospective Randomized Controlled Study.

BACKGROUND AND OBJECTIVES: The selective electrothermolysis of the sebaceous glands was suggested as a novel therapeutic option for facial acne. However, there has been no randomized controlled trial to evaluate the effectiveness and safety of the monopolar radiofrequency (RF) device using single microneedle with proximal insulation. The objective of the study was to evaluate the efficacy and tolerability of intralesional electrothermolysis using monopolar RF device and proximally-insulated single microneedle in acne patients. STUDY DESIGN/MATERIALS AND METHODS: The prospective randomized controlled clinical trial was performed to treat moderate-to-severe facial acne. Subjects randomized to the treatment group received three treatments at 4-week intervals with an RF device, whereas the control group received micro-needling and extraction. For efficacy evaluation, reduction rate of acne lesions were evaluated by two independent physicians. RESULTS: Sixty-three patients completed the study and the results showed statistically significant improvement of inflammatory acne at 12 weeks. The number of inflammatory lesions was significantly reduced at 12 weeks (20.86 vs. -5.13; P = 0.03) compared with controls. CONCLUSIONS: Selective sebaceous gland electrothermolysis can be a safe and effective method of achieving consistent improvement in acne. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.

Randomized, Patient/Evaluator-Blinded, Intraindividual Comparison Study to Evaluate the Efficacy and Safety of a Novel Hyaluronic Acid Dermal Filler in the Treatment of Nasolabial Folds.

BACKGROUND: Comparative research on the characteristics of filler products is limited, especially in the preclinical analysis of hyaluronic acid (HA) fillers. OBJECTIVE: This study was performed to compare the preclinical characteristics, clinical efficacy, and safety of a new HA filler, IDHF-001, with Restylane SubQ in the treatment of nasolabial folds (NLFs). METHODS: Viscoelasticity and injection force were evaluated. Ninety-one subjects were enrolled in this randomized, patient/evaluator-blind, intraindividual clinical study. Each subject was randomized to receive injections of IDHF-001 or Restylane SubQ in their left or right NLF. At 4, 8, 16, 24, 36, and 48 weeks, all participants were evaluated through Wrinkle Severity Rating Scale (WSRS). RESULTS: The IDHF-001 showed higher viscosity (1,271 Pa·s), lower elastic modulus (G'; 611 Pa), and lower injection force (8.89 N) than Restylane SubQ (464.6 Pa·s; 674.8 Pa; 19.14 N). No significant difference in WSRS was detected between IDHF-001 side and Restylane SubQ side at 24 weeks (mean improvement in WSRS from baseline at Week 24-IDHF-001: 1.85 ± 0.61, Restylane SubQ: 1.88 ± 0.61). The noninferiority was sustained until Week 48. CONCLUSION: The novel HA filler IDHF-001 shows suitable characteristics and tolerability, widening the selection possibilities for clinicians and patients in the treatment of NLFs.

Impending skin necrosis after dermal filler injection: A "golden time" for first-aid intervention.

Vascular compromise with impending skin necrosis is one of the most serious potential complications. Early recognition of vascular occlusion and swift and aggressive treatment are required to avoid any irreversible changes. However, initial symptoms of a vascular event are often dismissed as simple post-procedural discomfort. If more than 3 days pass after filler injection, crust formation is initiated over the erythematous base along with a rim of fibrous tissue. Due to the replacement of normal tissues by fibrous material, the healing process may result in scar formation in spite of debridement and aggressive dressing changes. Scars often cause contracture and subsequent cosmetic disfigurement, which results in a traumatic burden to the patient. By sharing our experience of the patients with filler induced skin necrosis, we suggest that treatment should be initiated no later than 3 days after the procedure.

Streptococcus sanguinis isolated from filler granuloma: Successful treatment with incision and drainage.

Filler granuloma is considered to be the result of delayed immune responses; growing evidence suggests that they may be secondary to biofilm formation. Dermal filler is technically a foreign body, and as the development of newer generations of dermal fillers lengthens their duration, it is possible that there is also an increased risk of biofilm formation. Here, we present a case report of a patient with Streptococcus sanguinis isolated from a filler granuloma, suggestive of biofilm formation. This case demonstrates the effective use of antibiotics after incision and drainage on antibiotic resistant biofilm.