A Phase 3, Randomized, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Neu-BoNT/A in Treatment of Primary Axillary Hyperhidrosis.

BACKGROUND: Botulinum toxin type A is widely used to treat primary axillary hyperhidrosis and has proven to be an effective and safe approach. Onabotulinumtoxin A was approved by the FDA as a treatment for primary axillary hyperhidrosis. This study aimed to evaluate the efficacy and safety of Neu-BoNT/A in subjects diagnosed with primary axillary hyperhidrosis. METHODS: The Hyperhidrosis Disease Severity Scale, gravimetric measurement of sweat, and Global Assessment Scale were analyzed at weeks 4, 8, 12, and 16 to determine the effect of treatment. Adverse events, physical examination, and vital signs were monitored. RESULTS: Subjects treated with Neu-BoNT/A showed statistically significant improvement by all 3 methods at weeks 4, 8, 12, and 16 (P value = 0.00). There were no severe adverse events or significant changes in vital signs, physical examination, or laboratory tests. CONCLUSION: Neu-BoNT/A can be effectively and safely used for primary axillary hyperhidrosis. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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.

Comparison of Facial Proportions Between Beauty Pageant Contestants and Ordinary Young Women of Korean Ethnicity: A Three-Dimensional Photogrammetric Analysis.

BACKGROUND: Although the harmony of facial proportions is traditionally perceived as an important element of facial attractiveness, there have been few objective studies that have investigated this esthetic balance using three-dimensional photogrammetric analysis. OBJECTIVES: To better understand why some women appear more beautiful, we investigated differences in facial proportions between beauty pageant contestants and ordinary young women of Korean ethnicity using three-dimensional (3D) photogrammetric analyses. METHODS: A total of 43 prize-winning beauty pageant contestants (group I) and 48 ordinary young women (group II) of Korean ethnicity were photographed using 3D photography. Numerous soft tissue landmarks were identified, and 3D photogrammetric analyses were performed to evaluate 13 absolute lengths, 5 angles, 3 volumetric proportions, and 12 length proportions between soft tissue landmarks. RESULTS: Group I had a greater absolute length of the middle face, nose height, and eye height and width; a smaller absolute length of the lower face, intercanthal width, and nasal width; a larger nasolabial angle; a greater proportion of the upper and middle facial volume, nasal height, and eye height and width; and a lower proportion of the lower facial volume, lower face height, intercanthal width, nasal width, and mouth width. All these differences were statistically significant. CONCLUSIONS: These results indicate that there are significant differences between the faces of beauty pageant contestants and ordinary young women, and help elucidate which factors contribute to facial beauty. The group I mean values could be used as reference values for attractive facial profiles. LEVEL OF EVIDENCE V: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Effect of Lactobacillus plantarum LMT1-48 on Body Fat in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: We investigated whether Lactobacillus plantarum strain LMT1-48, isolated from Korean fermented foods and newborn feces, is a suitable probiotic supplement to treat overweight subjects. METHODS: In this randomized, double-blind, placebo-controlled clinical trial, 100 volunteers with a body mass index of 25 to 30 kg/m2 were assigned randomly (1:1) to receive 2×1010 colony forming units of LMT1-48 or to a placebo treatment group. Body composition was measured by dual-energy X-ray absorptiometry, and abdominal visceral fat area (VFA) and subcutaneous fat area were measured by computed tomography scanning. Changes in body fat, VFA, anthropometric parameters, and biomarkers were compared between the two treatment groups (ClinicalTrials.gov number: NCT03759743). RESULTS: After 12 weeks of treatment, the body weight decreased significantly from 76.6±9.4 to 75.7±9.2 kg in the LMT1-48 group but did not change in the placebo group (P=0.022 between groups). A similar pattern was found in abdominal VFA between the two groups (P=0.041). Serum insulin levels, the corresponding homeostasis model assessment of insulin resistance, and leptin levels decreased in the LMT1-48 group but increased in the placebo group (all P<0.05). Decrease in body weight and body mass index by treatment with LMT1-48 was correlated with increase in Lactobacillus levels significantly. LMT1-48 also increased Oscillibacter levels significantly, which were negatively correlated with triglyceride and alanine transaminase levels. CONCLUSION: Administration of LMT1-48 decreased body weight, abdominal VFA, insulin resistance, and leptin levels in these subjects with overweight, suggesting its anti-obesogenic therapeutic potential.

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cholic Acid (MT921) after a Subcutaneous Injection in the Submental Area to Humans.

This study aimed to explore pharmacokinetics, pharmacodynamics, and safety/tolerability of MT921, an injectable cholic acid, after a single subcutaneous administration to healthy volunteers. A randomized, double-blinded, placebo-controlled, single dose-ascending phase 1 study enrolled 24 subjects who were assigned to three groups (60 mg, 120 mg, and 150 mg) of MT921. Blood samples were obtained for a 24-h period before and after injecting MT921 to the submental fat area. Plasma concentrations of cholic acid and deoxycholic acid were determined for pharmacokinetic analysis. Levels of free fatty acid, triglyceride, and total cholesterol were measured for pharmacodynamic analysis. Safety and tolerability were assessed until 21 days post-dose. While systemic exposure to cholic acid tended to increase as the MT921 dose increased, pharmacokinetic profiles of deoxycholic acid were similar among dose groups without showing significant changes. Pharmacodynamic profiles were comparable when measured at baseline and post-dose. The most frequent adverse events were injection site pain and edema. All adverse drug reactions resolved without treatment. MT921 appeared to be well-tolerated after an injection to the submental area at a dose up to 150 mg. Systemic exposure to cholic acid increased as the dose increased. Blood lipid profiles and deoxycholic acid levels were not affected by MT921 treatment.

Efficacy and safety of neuronox® for lateral canthal lines: a phase I/III, multicenter, randomized, double-blind, active-controlled study.

INTRODUCTION: Neuronox® has not yet been investigated for its efficacy and safety in the treatment of lateral canthal lines (LCL). METHODS: This study was a randomized, double-blind, active drug controlled, multicenter, 16 week, Phase I/III study designed to determine the non-inferiority of Neuronox® compared to onabotulinumtoxin A (ONA) in the treatment of moderate to severe LCL. Thirty subjects in Phase I and 220 subjects in Phase III were randomized in a 1:1 ratio to receive a single treatment (24 U) of either Neuronox® or ONA. The primary endpoint of the Phase III study was the responder rate according to the proportion of subjects achieving Grade 0 (none) or 1 (mild) from 2 (moderate) or 3 (severe) in LCL severity at maximum smile as assessed by the investigators at Week 4. Additional efficacy endpoints and safety endpoints (adverse events) were also evaluated. RESULTS: The primary endpoint was achieved as the proportion of responders was 83% for both Neuronox® and ONA, thus, supporting the non-inferiority of Neuronox® compare to ONA. The two groups also showed no statistical differences in safety analyses. CONCLUSION: Treatment of moderate to severe LCL with Neuronox® was effective and well-tolerated.

Three-Dimensional Photogrammetric Study on Age-Related Facial Characteristics in Korean Females.

BACKGROUND: Understanding the age-related morphological changes of facial soft tissue is fundamental in achieving improved outcomes of rejuvenating procedures. Three-dimensional (3D) photogrammetry is a reliable and convenient anthropometric tool to assess facial soft tissue. OBJECTIVE: The aim of this study was to establish age-related facial soft tissue morphology in Korean adult females using non-invasive 3D photogrammetry. METHODS: One hundred and ninety-two female participants were divided into three groups based on age: the younger group (aged 20~39 years), middle group (40~59 years), and older group (60~79 years). Thirty-six landmarks were identified via 3D photogrammetric scanning (Morpheus 3D, Morpheus Co., Ltd., Seongnam, Korea). Forty-one facial dimensions were analyzed using the imaging software to find significance between the age groups. RESULTS: Smaller upper-facial volume (p=0.019) and shorter upper-facial height (p=0.034) were observed in the older group than in the younger group. In the mid-face, narrowed palpebral fissure (p<0.001) with elongated upper eyelid height (p<0.001) and widened nose (p<0.001) were observed in the older group compared with the younger group. Longer lower-facial height (p<0.001) with longer and wider philtrum (p<0.001, p=0.004, respectively), shorter lower vermilion height (p<0.001), wider mouth width (p<0.001), and smaller lower vermilion angle (p<0.001) were seen in the older group when compared with the younger group. Moreover, greater angles of nasofrontal, nasomental, and labiomental angle (p=0.015, p=0.015, p=0.080, respectively), and smaller nasofacial angle (p=0.034) were observed in the older group than in the younger group. CONCLUSION: Our results provide clues of aging-related facial morphological characteristics in Korean female population.

"A Multi-center, randomized, double blinded, comparative study of two hyaluronic acid fillers for temporary restoration of mid-face volume in Asians".

BACKGROUND: There have been few studies using hyaluronic acid fillers to restore mid-face volume deficit especially in Asians. AIMS: This study compared the efficacy and safety of two highly cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine (VYC-20L), for temporary restoration of mid-face volume in Asians. PATIENTS/METHODS: A total of 88 subjects with moderate to severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received Neuramis® Volume Lidocaine on one side and VYC-20L on the other side of the face. Response was defined as a ≥1 point reduction in MFVDS at 24 weeks after the injection by photographic assessment. Secondary end points included photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements, as assessed by the investigators and the subjects at each visit; and the proportion of subjects who received touch-up treatment. RESULTS: The response rates of the sides treated with Neuramis® Volume Lidocaine and VYC-20L were identical (96.39%) at week 24, demonstrating that Neuramis® Volume Lidocaine was noninferior to VYC-20L. Photographic and live assessments of MFVDS and its changes, global aesthetic improvement, and the proportion of subjects who received touch-up treatment did not differ significantly during follow-up. CONCLUSIONS: Neuramis® Volume Lidocaine was not inferior to VYC-20L in temporarily restoring mid-face volume at 24 weeks after treatment. Both of these highly cohesive hyaluronic acid fillers can be used effectively and safely for the correction of mid-face volume loss in Asians.

A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial.

PURPOSE: To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery. MATERIALS AND METHODS: In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity. RESULTS: The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred. CONCLUSION: ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).