Long-term duration and safety of Radiesse (+) for the treatment of jawline.

BACKGROUND: Calcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment. METHODS: Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group. RESULTS: Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild. CONCLUSIONS: CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03583359.

Three-dimensional speckle tracking echocardiography for evaluation of ventricular function in patients with systemic lupus erythematosus: relationship between duration of lupus erythematosus and left ventricular dysfunction by using global longitudinal strain.

BACKGROUND: Cardiovascular diseases are leading causes of morbidity and mortality in patients with systemic lupus erythematosus (SLE). Cardiac involvement in SLE can often go undetected. Three-dimensional (3D) speckle tracking echocardiography (STE) is a noninvasive imaging technique that can assess the function of the heart's ventricles in an accurate and reproducible way. This makes it an attractive option for detecting early signs of heart disease in SLE patients. By identifying these subclinical cardiac abnormalities, 3D-STE may help reduce the negative impact of cardiovascular diseases in SLE population. Therefore, this study aimed to compare the left ventricular (LV) function between patients with SLE compared to age- and gender-matched controls using two-dimensional (2D) and 3D-STE. RESULTS: The current study found no significant differences in left ventricle ejection fraction, left ventricle end-diastolic volume, left ventricle end-systolic volume, left ventricle end-diastolic mass, and left ventricle end-systolic mass between the two groups. However, the SLE group exhibited a significantly lower LV global longitudinal strain (GLS) compared to the control group according to all types of echocardiographic assessments, including 3D and 2D long-axis strain, apical 2-chamber, and apical 4-chamber assessments (all P values < 0.05). Furthermore, a good inter-rater reliability and intra-rater reliability were observed regarding the LVGLS measurement with 3D-STE. Additionally, the study identified a significant correlation between LVGLS and SLE duration (r (50) = 0.46, P < 0.001). The use of prednisolone and nephrology disorders was also found to impact LVGLS measurements. CONCLUSIONS: Despite a normal LVEF in patients with SLE, LVGLS measurements indicated that LV systolic dysfunction was observed more frequently in SLE patients compared to their healthy counterparts. Therefore, advanced 3D-STE techniques may be useful in identifying subtle abnormalities in LV function in SLE patients.

Evaluation of the Effect of Conversion of Nonvalvular Atrial Fibrillation to Sinus Rhythm on Cardiac Remodeling.

BACKGROUND: Atrial fibrillation (AF) represents the most prevalent cardiac arrhythmia globally, with a significant burden on mortality and morbidity. While rhythm control strategies, particularly electrical cardioversion (EC), have gained traction in recent years, the precise impact of sinus rhythm (SR) restoration on cardiac reverse remodeling remains a subject of debate. METHODS: In this study, 23 AF patients underwent elective EC. AF diagnosis was made via ECG by a cardiologist, and candidates for cardioversion were selected by an electrophysiologist. Transthoracic echocardiography (TTE) by utilizing two-dimensional, three-dimensional, and tissue Doppler imaging modalities was performed before cardioversion. Patients who maintained SR after six months underwent a second TTE evaluation. RESULTS: SR was restored successfully in all 23 patients and 15 patients (65.2%) maintained SR after six months. SR group had significantly lower baseline cardiac output (CO) and indexed left ventricular end-systolic volume (LVESVi), and better European Heart Rhythm Association (EHRA) scores after six months. Within the SR group, patients exhibited significant changes in mitral regurgitation, tricuspid regurgitation, EHRA score, LVESVi, stroke volume, left ventricle ejection fraction, left ventricle global longitudinal strain, indexed minimum left atrial volume, left atrial emptying fraction, and left and right atrial diameters. Reduced CO was associated with AF recurrence. Receiver operating curve analysis revealed that CO value can predict six-month AF recurrence with a cut-off point of 2.3. CONCLUSION: Our study underscores the beneficial effects of SR restoration on cardiac parameters in AF patients post EC. Notably, CO value emerged as a predictor of AF recurrence, emphasizing the importance of comprehensive assessments for predicting long-term outcomes.

Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

Coronary artery calcification score as a prognostic indicator for COVID-19 mortality: evidence from a retrospective cohort study in Iran.

Background: Coronary artery calcification (CAC) has been established as an independent risk factor for major adverse cardiovascular events. Nevertheless, the effect of CAC on in-hospital mortality and adverse clinical outcomes in patients with COVID-19 has yet to be determined. Objective: To investigate the association between CAC score and in-hospital mortality of COVID-19 patients. Method: This retrospective cohort study was conducted across tertiary hospitals of University of Medical Sciences in Babol, a northern city in Iran, and enroled 551 confirmed COVID-19 patients with definitive clinical outcomes of death or discharge between March and October 2021. Demographic and clinical data, along with chest computed tomography (CT) findings and CAC score on admission, were systematically collected. The study utilized logistic regression analysis and Kaplan-Meier plots to explore the association between CAC score and in-hospital death and adverse clinical outcomes. Results: The mean age was 60.05±12.8. A significant difference regarding CAC score, age, history of hypertension, hyperlipidemia, cardiovascular diseases, and respiratory diseases among survivors and non-survivors was observed; however, gender was not found to be different. Furthermore, in multivariate analysis, CAC score greater than or equal to 400 [odds ratio (OR): 4.2, 95% CI: 1.70-10.33, P value: 0.002], hospitalization time (OR: 1.31, 95% CI: 1.13-1.53, P value < 0.001), length of ICU stay (OR: 2.02, 95% CI: 1.47-2.77, P value < 0.001), severe or critical COVID-19 severity in time of admission (95% CI: 1.79-18.29, P value: 0.003), and history of respiratory diseases (95% CI: 2.18-40, P value: 0.003) were found to be associated with higher odds of in-hospital mortality. Log-rank test also revealed a significant difference regarding the time of admission to death between patients with CAC score greater than or equal to 400 and those with CAC score less than 400 (P value < 0.001). Conclusion: Elevated CAC score is a crucial risk factor linked to in-hospital mortality and unfavourable clinical results in confirmed COVID-19 patients. This finding emphasizes the need for careful monitoring of individuals with high CAC scores.

Improvement in right heart function following kidney transplantation in esrd patients: insights from speckle tracking echocardiography analysis.

Chronic kidney disease (CKD) is commonly associated with unfavorable cardiovascular outcomes and remains the leading cause of mortality in individuals with end-stage renal disease (ESRD). Despite substantial knowledge about the impact of CKD on the left heart, the right heart, which holds significant clinical relevance, has often been overlooked and inadequately assessed in ESRD patients who have undergone kidney transplant (KTx). This study aimed to evaluate the effects of KTx on the right heart chambers in ESRD patients. 57 adult KTx candidates were enrolled in this prospective longitudinal study, while 49 of them were included in the final assessment. Patients underwent a comprehensive cardiac assessment, including conventional echocardiography, speckle tracking echocardiography, and three-dimensional heart modeling both before and after surgery. Echocardiographic assessments showed significant increases in right ventricular (RV) ejection fraction, RV fractional area change (RVFAC), tricuspid annular plain systolic excursion, RV fractional shortening, right atrial (RA) reservoir, conduit, and booster strains, and RV global longitudinal strain (RVGLS). Moreover, significant reductions in RV end-diastolic volume (RVEDV), RV end-systolic volume (RVESV), RV stroke volume, RV end-diastolic diameter (RVEDD) in mid-cavity view, systolic pulmonary artery pressure was observed (all P values < 0.05). However, no significant difference was found in S velocity, as well as RVEDD in basal and apex-to-annulus view. Moreover, pre-KTx measurements of RVGLS, RVEDD (apex-to-annulus diameter), RV fractional shortening, and S velocity were predictors of RVGLS after KTx. RA conduit strain was also identified as a predictor of RA conduit strain after KTx. Additionally, age, RVEDV, RVESV, RVFAC, and RA reservoir strain before KTx were identified as independent predictors of RA reservoir strain after KTx. The findings of this study demonstrate a significant improvement in right heart function following KTx. Furthermore, strain analysis can provide valuable insights for predicting right heart function after KTx.

Validation of a Midfacial Scale and Its Use in a Randomized, Evaluator-Blinded Study of CPM-HA-V.

BACKGROUND: Age-related loss of midfacial contour is frequently corrected using dermal fillers. A validated photonumeric scale is beneficial when evaluating post-treatment aesthetic improvement. OBJECTIVE: To present scale-development activities for the Merz Cheek Fullness Assessment Scale (MCFAS) and report pilot-study results of a hyaluronic-acid filler (Belotero Volume with Lidocaine; CPM-HA-V) to treat midfacial volume loss. METHODS: A 5-point photonumeric scale was developed to objectively assess midface volume loss. Rater reliability was evaluated using live assessments. The clinical relevance of a 1-point difference in severity grade was evaluated using photographic comparisons. Pilot-study participants, with moderate-to-severe volume loss on the MCFAS, were randomized 2:1 to treatment or untreated control. Effectiveness was evaluated using the MCFAS, and adverse events were recorded. RESULTS: The MCFAS demonstrated substantial intra- and interrater agreement among physicians (weighted kappa > 0.6). The mean absolute difference (95% confidence interval) in scale ratings was 1.12 (1.00, 1.24) for photographic pairs differing by one grade and was 0.55 (0.48, 0.63) for pairs of the same grade, suggesting a 1-point difference is clinically relevant. In the pilot study, significant  (P < 0.0001) differences were observed in MCFAS response rates between treatment and control. No safety concerns were identified. CONCLUSION: The MCFAS is a validated, reliable, and clinically relevant photonumeric scale for rating midfacial volume loss in males and females of various ages and skin types. In a pilot study, CPM-HA-V was found to be safe and tolerable, and the MCFAS was able to detect clinically meaningful post-treatment changes. J Drugs Dermatol. 2024;23(1):     doi:10.36849/JDD.7981.

Prevalence of refractive errors in population aged 50 years and over: The Gilan eye study.

PURPOSE: To describe the prevalence of refractive error (RE) and its association with other environmental and health factors among population aged ≥50 years who lived in Gilan, Iran in 2014. METHODS: In this population-based cross-sectional study, 3281 individuals aged ≥50 years living in Gilan for at least 6 months were enrolled. The prevalence of different types of REs including myopia (spherical equivalent (SE)≤-0.50D), high myopia (SE ≤ -6.00D), hyperopia (SE≥ + 0.50D), high hyperopia (SE≥ + 3.00D), astigmatism (cylinder < -0.50D) and high astigmatism (cylinder < -2.25D) were determined. Anisometropia was defined as the SE difference of ≥1.00D between the two eyes. Associated factors including age, body mass index (BMI) and education were also studied. RESULTS: 2587 eligible individuals (58% female subjects) with the mean age of 62.6 ± 8.8 years participated (87.6% response rate). The prevalence of myopia, hyperopia and astigmatism was 19.2%, 48.6% and 57.4%, respectively. 3.6% high hyperopia, 0.5% high myopia and 4.5% high astigmatism were identified. The positive simultaneous effects3 of older age (Odds Ratio (OR) = 3.14), nuclear (OR = 1.71) and posterior subcapsular (OR = 1.61) cataracts as well as the negative effects of higher levels of education (OR = 0.28) were obtained on myopia. Higher BMI was found as a risk factor for hyperopia (OR = 1.67), while older patients were less likely to be hyperopic (OR = 0.31). CONCLUSION: Higher incidence of myopia and astigmatism was found in patients aged over 70 years. It was also found that patients at older ages who suffered with cataracts were at a higher risk of myopia, while elderly people with greater BMI were at a higher risk of hyperopia.

Multicenter evaluation of a topical antioxidant serum.

BACKGROUND: A new antioxidant serum has been formulated with sodium ascorbate, a sodium salt of Vit C, which aims to address facial photodamage while maintaining a low irritation profile and preserving elastin. Detailed background science has been submitted in a previous publication. This open-label study was conducted to validate the science by demonstrating product efficacy and tolerability in patients with moderate to severe facial photodamage. METHODS: A multicenter, open-label clinical study was undertaken over 5 months from March 2023 to July 2023. Thirty six eligible participants (35 female, 1 male), aged 38-69 years, and Fitzpatrick skin types II-V were enrolled into and completed the study following 12 weeks of the topical antioxidant serum use twice daily, along with the following supporting products (gentle cleanser, moisturizer, and sunscreen for as needed use). Follow-up visits were conducted in Weeks 2, 4, 8, and 12. At every visit, participants were evaluated for facial photodamage severity and test product tolerability. Additionally, study participants underwent subject assessments and satisfaction questionnaires, investigator assessments, biopsy collection, and photography. RESULTS: Significant improvements in all evaluated facial photodamage parameters were observed at 12 weeks together with excellent tolerability and subject satisfaction persisting to Week 12 at study completion. Histology most notably revealed increased elastin fibers in 5 out of 5 post 12-week treatment biopsies on Movat staining, while Herovici stains revealed stimulation of collagen and early formation of new fibers. CONCLUSION: A novel antioxidant serum has demonstrated to be safe and effective for addressing facial photodamage, while stimulating the production of both elastin and collagen in the extracellular matrix (ECM).

Compositional and Morphological Analysis of Salt Stress Tolerant Mannitol-1-phosphate Dehydrogenase (mtlD)-Transgenic Potato Plants.

Undesired effects often occur in genetically modified (GM) plants, especially during metabolite engineering. Nevertheless, conducting a comparative study between GM and non-GM plants can identify the unintended alterations and facilitate the risk assessment of GM crops. This research compared the morphology and composition of a transgenic potato plant expressing mannitol-1-phosphate dehydrogenase (mtlD), with its non-transgenic counterpart. The results indicated significant differences in plant height, number of leaves, length and width of leaves, as well as tuber number and weight between the transgenic and non-transgenic plants. However, compositional analysis revealed no significant differences in soluble protein, starch, total sugar, fructose, fiber, and ascorbate contents between mtlD-GM and non-GM potatoes. Nevertheless, sucrose and glucose levels were found to be higher in the transgenic potato tubers and leaves, respectively, when compared to the non-transgenic plants. In addition to ammonium, potassium, chloride, nitrite, and nitrate levels, significant differences were observed in the amino acids asparagine, aspartic acid, glutamic acid, isoleucine, leucine, lysine, serine, and valine between the GM and non-GM plants. Apart from the target gene product, mannitol, all the changes in chemical compositions observed in the transgenic potato plants fell within the ranges of normal variability for potato plants. Moreover, despite some phenotypical differences between the mtlD-GM potato and its non-GM counterpart, it is believed that this variation is a common phenomenon among potato varieties. In conclusion, the morphological and compositional analysis of the mtlD-GM potato plant revealed substantial equivalence with its non-transgenic counterpart.

Unusual presentation of transthyretin (ATTR) cardiac amyloidosis: A case report of pruritus as a possible initial symptom and challenging diagnosis.

Key Clinical Message: This case emphasizes the significance of cardiac amyloidosis as a potential diagnosis in individuals manifesting with lesion-free pruritus and normal liver tests. Abstract: Amyloidosis is a complex disorder in which misfolded proteins accumulate in various organs of the body. Cardiac amyloidosis (CA) can lead to heart failure, cardiac arrhythmia, sudden cardiac death, and deposition of proteins in coronary arteries. Diagnosing CA can be difficult, as the cardiac manifestations of amyloidosis can be similar to more prevalent etiologies. In addition, the accumulation of proteins in soft tissues, including the skin, can cause pruritus. In this paper, we present a 70-year-old man with generalized pruritus and no skin lesions, later diagnosed as CA after detecting ascites fluid. This case underscores the importance of considering amyloidosis in patients presenting with nonspecific symptoms, particularly those affecting the skin, and highlights the need for increased awareness of this disease among clinicians.

Guidelines for Optimal Patient Outcomes Using Calcium Hydroxylapatite for Jawline Contour.

Background: Calcium hydroxylapatite (CaHA(+); Radiesse(+) [Merz North America, Inc., Raleigh, NC]) is the first FDA-approved injectable filler for subdermal and/or supraperiosteal injection to improve moderate-to-severe loss of jawline contour. CaHA has been recognized in the past for its ability to provide contour and support overlying tissues and utilized for jawline augmentation well before this recent indication; however, with recent FDA approval of CaHA(+) for jawline contour improvement, it is important that clinicians are aware of best practices for patient selection, treatment planning and injection, as well as safety considerations and postprocedure care. Objectives: To provide guidance on best practices for patient assessment and on-label use of CaHA(+) for jawline rejuvenation and augmentation. Methods: As part of a 2-h roundtable discussion, 5 clinicians with expertise in both the use of CaHA(+) and jawline treatment discussed patient selection, CaHA(+) injection technique, and important safety measures, with the purpose of developing guidance to support optimal clinical use. Results: The most common applications of CaHA(+) in the jawline are rejuvenation of the prejowl sulcus, recontouring the jawline, and providing definition to the gonial angle. Improving the gonial angle is of particular interest as it is a procedure sought by patients of all genders and ages. Variations in technique are discussed and case studies are presented. Conclusions: Jawline augmentation is a procedure with wide-ranging appeal for a diverse array of patients. CaHA(+) is an ideal filler for jawline augmentation due to its rheologic properties (high G') and ability to achieve defined contours and angles. Appropriate injection technique permits effective treatment and outcomes associated with high patient satisfaction.

Cellulite Pathophysiology and Psychosocial Implications.

BACKGROUND: Cellulite is a highly prevalent aesthetic condition in postpubertal women. OBJECTIVE: The objective of this article was to describe the latest data on the pathophysiology of cellulite and to highlight the psychosocial aspects that should be considered when treating cellulite. METHODS: A roundtable meeting was convened to discuss and share views on the latest data on the pathophysiology and psychosocial aspects of cellulite. The participants' experience helped guide a narrative review on this topic. RESULTS: The pathophysiology of cellulite primarily involves fibrous septal changes. Strategies targeting the fibrous septa have shown the most consistent efficacy, while showing inconsistent or short-term results when targeting the other components of cellulite, such as decreased dermal thickness, vascular alterations, and inflammation. Female sex, increased age, and high body mass index contribute to cellulite pathophysiology. CONCLUSION: Patients seeking treatment for cellulite are willing to endure numerous treatments, high cost, temporary and/or delayed results, and invasive procedures with potential adverse effects. Psychological discomfort has been reported among patients with cellulite, and understanding their behaviors and psychological characteristics can help clinicians provide better care to these patients seeking treatment.

Cellulite: Clinical Challenges and Future Perspectives.

BACKGROUND: Existing cellulite interventions pose various clinical challenges related mostly to ecchymosis and recovery time. OBJECTIVE: To discuss the current treatment options for minimizing recovery time, efficacy of these options, and investigations into possible future approaches. METHODS: A roundtable meeting was convened to discuss and share views on the clinical challenges seen in the present practice of cellulite treatments along with future approaches and mitigation strategies. The participants' views helped guide a narrative review on this topic. RESULTS: Cosmetic clinicians have a range of new interventions to choose from for cellulite improvement, each with different benefits and safety aspects. Bruising is a typical side effect that is seen with treatments targeting the fibrous septa, such as subcision and injectable treatments, and in some cases may produce long-lasting hyperpigmentation from postinflammatory hyperpigmentation or hemosiderin staining. Various strategies that could potentially mitigate bruising and other adverse effects of cellulite treatment are under clinical investigation, including, but not limited to, different injection techniques and dilutions, compression garments, cold packs, arnica gel, pulsed dye laser treatment, intralesional epinephrine, and tranexamic acid. CONCLUSION: Clinical challenges including varying treatment outcomes and certain treatment sequelae remain, and further research is needed to prevent side effects and improve treatment outcomes.

Development and Validation of a Photonumeric Scale for Evaluation of Jawline Contour.

BACKGROUND: A naturally aged face is often characterized by a noticeable lack of jawline contour and decreased volume in the lower region. Several options are available to redefine the jawline. To objectively evaluate treatment-related improvements in clinical practice and research, a validated photonumeric scale is needed. OBJECTIVE: To present scale-development methods for the Merz Jawline Assessment Scale and establish its reliability. METHODS: A 5-point photonumeric scale was developed to objectively assess jawline volume loss and contour disruption using male and female subjects of various ages and skin types. Seven board-certified dermatologists and plastic surgeons evaluated 90 subjects live in 2 sessions, 3 weeks apart to establish intra- and interrater reliability. RESULTS: The weighted kappa for intra- and interrater agreement were ≥ 0.7 in all cases. Intrarater agreement between the 2 rating sessions was nearly perfect (median weighted kappa = 0.908). Substantial interrater agreement between each rater pair was also demonstrated for both rating sessions. CONCLUSION: The Merz Jawline Assessment Scale is a validated and reliable photonumeric scale for rating loss of jawline volume and contour. The scale maintains its validity and reliability with reproducible results across a diverse group of males and females of various ages and Fitzpatrick skin types. J Drugs Dermatol. 2023;22(2):203-209. doi:10.36849/JDD.7193.

A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris.

BACKGROUND AND OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA (ONA) injections to the depressor anguli oris (DAO) to improve downturned mouth. PATIENTS AND METHODS/MATERIALS: This prospective, placebo-controlled, study enrolled subjects aged 18 to 65 years. Injections were performed using a novel 3-point technique in the upper DAO (1.5 U/injection site). The primary end point was a DAO contraction scale 1-grade improvement. Subjective evaluation was performed using the Global Aesthetic Improvement Scale (GAIS). RESULTS: Ten subjects received ONA and 10 placebo (saline) injections. In ONA-treated subjects, DAO scores showed significant improvements at Weeks 4 and 12 ( p < .001) compared with baseline. No significant difference between visits was observed for placebo-injected subjects. Global Aesthetic Improvement Scale scores showed that 100% of subjects were improved compared with baseline at Week 4% and 90% at Week 12. By contrast, 90% and 80% of placebo-treated subjects had "no change" in their DAO appearance at Weeks 4 and 12. Subject GAIS assessments matched the live evaluator at Week 4; 60% continued to report improvement at Week 12. Treatment was well tolerated. CONCLUSION: OnabotulinumtoxinA injections to the DAO using a 3-point technique provide clinically meaningful improvements in appearance. Treatment was well tolerated and in most individuals lasted at least 12 weeks. IDENTIFIER: ClinicalTrials.gov NCT04240535.

ODSS vs. ABSIS and PDAI oral parts in pemphigus vulgaris: inter-rater reliability and testing times.

OBJECTIVES: The existence of standard methods for diagnosis and measuring the severity of diseases leads to a more accurate severity assessment, the possibility of following up, and the possibility of comparing the results of studies. This study aimed to compare different pemphigus vulgaris (PV) assessment methods regarding inter-observer reliability and testing times-focusing on oral parts. MATERIALS AND METHODS: Two dermatologists evaluated orally involved PV patients by oral parts of Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), Pemphigus Disease Area Index (PDAI), and Oral Disease Severity Score (ODSS). RESULTS: Seventy patients completed the study. The intraclass correlation coefficient showed the evaluators' agreements on ABSIS, PDAI, and ODSS with 0.98, 0.94, and 0.95, respectively. Reliability analyses showed near-perfect relationships between each scoring methods pairs. There was no association between lesion sites and disease severity. The PDAI scoring duration was significantly shorter, and the ABSIS scoring duration was significantly longer. CONCLUSION: ODSS is valid for evaluating oral involvement in patients with PV and relates to ABSIS and PDAI almost perfectly. Besides, it was shown that the evaluation of patients' oral involvement based on PDAI and ODSS is done in about 1 min, which seems clinically reasonable.

Aesthetic Implantation of Calcium Hydroxylapatite Does Not Interfere With Radiological Assessment of Bones in the Dorsum of the Hands.

BACKGROUND: Calcium hydroxylapatite (CaHA) is a radiopaque dermal filler used to provide volume correction in the dorsum of the hand. OBJECTIVES: The aim of this study was to evaluate whether CaHA implantation in the dorsum of the hand interferes with radiological assessment by obscuring the bones. METHODS: This 2-year, prospective, single-center, open-label study enrolled 20 subjects with Merz Hand Grading Scale (MHGS) grades ranging from moderate (MHGS 2 or 3; n = 10) to very severe (MHGS 4; n = 10). All subjects received an initial CaHA treatment and were offered up to 3 retreatments to provide volume correction in the dorsum of the hands, over a period of 18 months. Bone obscuration was assessed by blinded, licensed radiologists responsible for interpreting plain radiographs (X-rays). RESULTS: CaHA was seen to be present in 100% of hands in Month 1 X-rays and in 83.3% in Month 24 X-rays, but no bone obscuration was reported in any X-rays at any evaluated time point. CONCLUSIONS: According to blinded radiologists, treatment with CaHA in the dorsum of the hand does not obscure radiographic assessment of the bones seen on X-rays up to 24 months after initial injection. The safety of CaHA retreatment was also demonstrated by the lack of bone obscuration after multiple retreatments.

A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion.

BACKGROUND: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. METHODS: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne ( n = 107) or no treatment ( n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. RESULTS: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) ( p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 ( p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. CONCLUSIONS: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Determination of protoplast growth properties using quantitative single-cell tracking analysis.

BACKGROUND: Although quantitative single-cell analysis is frequently applied in animal systems, e.g. to identify novel drugs, similar applications on plant single cells are largely missing. We have exploited the applicability of high-throughput microscopic image analysis on plant single cells using tobacco leaf protoplasts, cell-wall free single cells isolated by lytic digestion. Protoplasts regenerate their cell wall within several days after isolation and have the potential to expand and proliferate, generating microcalli and finally whole plants after the application of suitable regeneration conditions. RESULTS: High-throughput automated microscopy coupled with the development of image processing pipelines allowed to quantify various developmental properties of thousands of protoplasts during the initial days following cultivation by immobilization in multi-well-plates. The focus on early protoplast responses allowed to study cell expansion prior to the initiation of proliferation and without the effects of shape-compromising cell walls. We compared growth parameters of wild-type tobacco cells with cells expressing the antiapoptotic protein Bcl2-associated athanogene 4 from Arabidopsis (AtBAG4). CONCLUSIONS: AtBAG4-expressing protoplasts showed a higher proportion of cells responding with positive area increases than the wild type and showed increased growth rates as well as increased proliferation rates upon continued cultivation. These features are associated with reported observations on a BAG4-mediated increased resilience to various stress responses and improved cellular survival rates following transformation approaches. Moreover, our single-cell expansion results suggest a BAG4-mediated, cell-independent increase of potassium channel abundance which was hitherto reported for guard cells only. The possibility to explain plant phenotypes with single-cell properties, extracted with the single-cell processing and analysis pipeline developed, allows to envision novel biotechnological screening strategies able to determine improved plant properties via single-cell analysis.