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Titanium alloy based implants are becoming more common with medical advancements and longer global life expectancy. With its geometrical design freedom, low material wastage, and mass customisation, additive manufacturing has found growing use in biomedical applications. In this study, laser shock peening without coating (LSPwC) was investigated as a means to enhance the surface and mechanical properties of selective laser melted Ti6Al4V implants. The application of LSPwC was found to induce a favourable surface oxide layer, increase the measured surface roughness and hardness, and reverse the tensile residual stresses imparting deep, high-magnitude compressive residual stresses. The combination of oxide layer, increased roughness, and induced compressive stress will potentially improve implant osseointegration and increase fatigue life.

STUDY DESIGN.: Prospective case series. OBJECTIVE.: To evaluate the change in spinal rod contour from before implantation to after surgical correction of thoracic curves in patients with adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA.: With segmental pedicle screw spinal instrumentation and vertebral derotation, many authors have reported a loss of thoracic kyphosis postoperatively. Although surgeons anticipate some flattening of the preimplantation rod contour in the sagittal plane, the magnitude of this change in shape has not been documented. METHODS.: The concave and convex rod shapes of 5.5-mm ultrahigh-strength steel spinal rods (200 KSI) from patients with thoracic adolescent idiopathic scoliosis (n = 27), which were contoured with benders by the surgeon, were traced prior to insertion. Postoperative (average, 5 weeks) sagittal rod shape was determined from lateral 2-dimensional radiographs. Maximal rod deflection and angle of the tangents to rod end points (Cobb) were measured. Repeated measures analysis of variance assessed differences between pre- and postoperation. RESULTS.: The scoliosis of 55° ±14° was corrected 72% to 15° ± 5°. The preinsertion rod shapes were more kyphotic for the concave (45.6°) than for the convex (31.4°) rods. Following correction, the concave rods flattened, with decrease in deflection of 13 mm and reduction in angle of 21° (both P < 0.001). The convex rods increased 1.5 mm in deflection and 2° in angle (P < 0.01, P = 0.18). The sagittal profile was maintained postoperatively as measured from T5-T12: 19° ±14° versus 22° ± 6° (pre vs. post, P > 0.1). CONCLUSION.: We found a significant difference between pre- and postoperative rod contour, particularly for concave rods. Rod overcontouring (by ~20° for concave rod) resulted in high degrees of correction without loss of sagittal alignment. The resulting deformations are likely associated with substantial in vivo deforming forces. [ABSTRACT FROM AUTHOR]

Study Design: Experimental study for systematic evaluation of 3-dimensional (3D) reconstructions from low-dose digital stereoradiography. Objective: To assess the accuracy of EOS (EOS Imaging, Paris, France) 3-dimensional (3D) reconstructions compared with 3D computed tomography (CT) and the effect spine positioning within the EOS unit has on reconstruction accuracy. Summary Of Background Data: Scoliosis is a 3D deformity, but 3D morphological analyses are still rare. A new low-dose radiation digital stereoradiography system (EOS) was previously evaluated for intra/interobserver variability, but data are limited for 3D reconstruction accuracy. Methods: Three synthetic scoliotic phantoms (T1-pelvis) were scanned in upright position at 0°, ±5°, and ±10° of axial rotation within EOS and in supine position using CT. Three-dimensional EOS reconstructions were superimposed on corresponding 3D computed tomographic reconstructions. Shape, position, and orientation accuracy were assessed for each vertebra and the entire spine. Additional routine planer clinical deformity measurements were compared: Cobb angle, kyphosis, lordosis, and pelvic incidence. Results: Mean EOS vertebral body shape accuracy was 1.1 ± 0.2 mm (maximum 4.7 mm), with 95% confidence interval of 1.7 mm. Different anatomical vertebral regions were modeled well with root-mean-square (RMS) values from 1.2 to 1.6 mm. Position and orientation accuracy of each vertebra were high: RMS offset was 1.2 mm (maximum 3.7 mm) and RMS axial rotation was 1.9° (maximum 5.8°). There was no significant difference in each of the analyzed parameters (P > 0.05) associated with varying the rotational position of the phantoms in EOS machine. Planer measurements accuracy was less than 1° mean difference for pelvic incidence, Cobb angle (mean 1.6°/maximum 3.9°), and sagittal kyphosis (mean less than 1°, maximum 4.9°). Conclusion: The EOS image acquisition and reconstruction software provides accurate 3D spinal representations of scoliotic spinal deformities. The results of this study provide spinal deformity surgeons evidence pertaining to this new upright 3D imaging technology that may aid in the clinical diagnosis and decision making for patients with scoliosis. [ABSTRACT FROM AUTHOR]

Abstract Background People overeat because their hunger directs them to consume more calories than they require. The purpose of this study was to analyze the changes in experience and perception of hunger before and after participants shifted from their previous usual diet to a high nutrient density diet. Methods This was a descriptive study conducted with 768 participants primarily living in the United States who had changed their dietary habits from a low micronutrient to a high micronutrient diet. Participants completed a survey rating various dimensions of hunger (physical symptoms, emotional symptoms, and location) when on their previous usual diet versus the high micronutrient density diet. Statistical analysis was conducted using non-parametric tests. Results Highly significant differences were found between the two diets in relation to all physical and emotional symptoms as well as the location of hunger. Hunger was not an unpleasant experience while on the high nutrient density diet, was well tolerated and occurred with less frequency even when meals were skipped. Nearly 80% of respondents reported that their experience of hunger had changed since starting the high nutrient density diet, with 51% reporting a dramatic or complete change in their experience of hunger. Conclusions A high micronutrient density diet mitigates the unpleasant aspects of the experience of hunger even though it is lower in calories. Hunger is one of the major impediments to successful weight loss. Our findings suggest that it is not simply the caloric content, but more importantly, the micronutrient density of a diet that influences the experience of hunger. It appears that a high nutrient density diet, after an initial phase of adjustment during which a person experiences "toxic hunger" due to withdrawal from pro-inflammatory foods, can result in a sustainable eating pattern that leads to weight loss and improved health. A high nutrient density diet provides benefits for long-term health as well as weight loss. Because our findings have important implications in the global effort to control rates of obesity and related chronic diseases, further studies are needed to confirm these preliminary results.

Background: AbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009., Objective: Pivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience., Materials and Methods: Patients seek an improvement in the appearance of their glabellar lines while maintaining a "natural look," fast onset of effect, and long duration of response., Results: Trial designs have evolved to meet these new targets, including expanding the definition of responders to those having at least 1-grade improvement in the glabellar line severity scale score from baseline coupled with the use of subject satisfaction and psychological well-being questionnaires., Conclusion: The findings demonstrate that abobotulinumtoxinA remains a well-tolerated and consistently effective treatment option associated with a rapid onset of effect, duration of efficacy lasting up to 6 months, and high, long-lasting levels of patient satisfaction., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Increased turnover and burnout of healthcare workers because of the COVID-19 pandemic made hiring ancillary staff in dermatology clinics a challenging task. As the dermatologic requirements of an aging population grow, demand for ancillary staff has also increased. We reviewed evidence-based strategies, best practices, and specific examples pertinent to dermatology to improve recruitment, hiring, and retention of non-physician staff in dermatology clinics.

Objective: Dermatology and aesthetic medicine has experienced significant growth in recent years, driven by industry-sponsored research performed by clinical investigators. Contract research organizations (CROs) play an important role to ensure clinical trials are run efficiently, ethically, and according to Good Clinical Practice. An advisory group of dermatologists and aesthetic researchers was assembled to obtain feedback about CRO experiences for developing a "next-generation" specialty CRO for dermatology and aesthetic medicine., Methods: Experienced dermatologists and aesthetic physician researchers convened during the 2022 Winter Dermatology Annual Meeting in Kauai, Hawaii, to discuss experiences and make suggestions regarding CROs. Topics included positive and negative aspects of CRO experiences, desirable CRO services, and how CROs can be improved., Results: Benefits of working with CROs include project, data, and resource management and availability of technology. Desired functions include rapid study start-up, subject recruitment, and accurate and organized site-related documentation. Other qualities include access to large subject populations close to study locations, use of CRO-based clinical research assistants to support principal investigators across study sites, and scientific consultation, protocol development, medical writing, project management, clinical and medical monitoring, data management, biostatistics, and pharmacovigilance., Conclusion: CROs serve a vital role in the development process of drug, device, and therapeutics; however, it is important that changes to traditional CRO models are made to provide improved interactions with researchers in dermatology and aesthetic medicine., Competing Interests: DISCLOSURES: The authors report no conflicts of interest relevant to the content of this article., (Copyright © 2022. Matrix Medical Communications. All rights reserved.)

Background: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs., Objectives: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs., Methods: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events., Results: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect., Conclusions: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables., (© 2022 The Aesthetic Society.)

Background/objectives: Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294)., Methods: In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children's Dermatology Life Quality Index., Results: Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials., Conclusions: Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis., (© 2020 The Authors. Pediatric Dermatology published by Wiley Periodicals, Inc.)

Background: ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF)., Objective: To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF., Patients and Methods: Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events., Results: Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site., Conclusion: ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

Background: Hand rejuvenation has become increasingly popular, but there are few reports published on the use of hyaluronic acid gels for correction of volume deficits in the dorsal hand., Methods: This study evaluated the efficacy and safety of large-gel-particle hyaluronic acid with lidocaine, a 20-mg/ml hyaluronic acid gel with 0.3% lidocaine, compared to no treatment for the correction of volume deficits in the dorsal hand. This was a prospective, multicenter, split-hand study in 90 subjects who received treatment with product in one hand. The primary efficacy endpoint was based on a 1 point of improvement with treatment versus no treatment according to the Merz Hand Grading Scale at week 12. Other assessments included Central Independent Photographic Reviewers evaluations of hand photographs, Global Aesthetic Improvement Scale, subject satisfaction, and safety., Results: The mean injection volume was 2.1 ml at the first treatment. Subjects demonstrated significantly higher response rates with treatment compared to no treatment at week 12 (85.9 percent versus 21.2 percent) and at weeks 16, 20, and 24 (p < 0.0001). Photographic Reviewers assessments showed consistently greater improvements in the treated hands compared with the untreated hands from week 12 to week 24. Most subjects and investigators (≥92.8 percent) reported improvements in Global Aesthetic Improvement Scale score across all time points with treatment. Treatment-related adverse events were reported in seven subjects (7.9 percent). Most of these were mild, and none were serious., Conclusion: Hyaluronic acid with lidocaine is safe, effective, and well tolerated for the correction of volume deficits in the dorsal hand., Clinical Question/level of Evidence: Therapeutic, II.

Background: Hyperhidrosis is estimated to affect ~ 4.8% of the US population, and most patients experience a negative psychological impact. Here, we describe development and psychometric evaluation of a patient-reported outcome (PRO) measure to assess severity of axillary hyperhidrosis in clinical trials that meets current U.S. regulatory standards to support product approvals., Methods: Three rounds of hybrid concept-elicitation/cognitive-debriefing qualitative interviews were conducted in adults with clinician-diagnosed primary axillary hyperhidrosis, followed by similar interviews in children/adolescents. The draft measure included diary items for presence, severity, impact and bothersomeness (basis of the Axillary Sweating Daily Diary [ASDD]), exploratory weekly impact items, and a single-item Patient Global Impression of Change (PGIC). Phase 2 (adults only) and phase 3 (adults and children ≥9 years) clinical trial data were utilized to evaluate measurement properties of the resulting draft measure: floor/ceiling effects, nonresponse bias, test-retest reliability, construct validity, and responsiveness were assessed. The primary concept of interest was axillary sweating severity (ASDD Item 2); however, additional supportive concepts were explored to allow for development of a comprehensive hyperhidrosis measure., Results: Twenty-nine patient interviews were conducted (N = 21 adult and N = 8 children/adolescents), resulting in the ASDD (4 items, patients ≥16y) and child-specific ASDD-C (2 items ≥9y to <16y), as well as 6 Weekly Impact items and the PGIC (patients ≥16y). No floor/ceiling effects or response biases were identified. Consistency between hypothesized and observed correlation patterns between ASDD/ASDD-C items and other efficacy measures supported construct validity. Intraclass correlation coefficients supported test-retest reliability (0.91-0.93; Item 2). Large effect sizes (- 2.2 to - 2.4) demonstrated that the ASDD/ASDD-C Item 2 could detect changes in hyperhidrosis severity, supporting the measure's responsiveness. Patients perceiving a moderate improvement in symptoms on the PGIC experienced an average 3.8-point improvement on ASDD axillary sweating severity (Item 2); thus, a 4-point responder threshold was defined as a clinically meaningful change., Conclusions: Qualitative and quantitative evidence support the reliability and validity of the ASDD/ASDD-C and its use in the clinical evaluation of axillary hyperhidrosis treatments. Further evaluation of this measure in future research studies is warranted to demonstrate consistent performance across different axillary hyperhidrosis populations and in different study contexts.

Background: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%)., Objective: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294)., Methods: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index., Results: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index., Conclusions: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged., Trial Registry: Clinicaltrials.gov NCT02553798.

Background: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine., Objectives: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement., Methods: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment., Results: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment., Conclusions: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment., (© 2018 The American Society for Aesthetic Plastic Surgery, Inc.)

Background: Glycopyrronium tosylate (GT) is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years. GT was evaluated for primary axillary hyperhidrosis in replicate, randomized, double-blind, vehicle-controlled, phase III trials. GT reduced sweating severity and production versus vehicle and was generally well tolerated., Objective: Our objective was to evaluate patient-reported outcomes (PROs) from these trials., Methods: Patients aged ≥ 9 years with primary axillary hyperhidrosis ≥ 6 months, gravimetrically measured sweat production ≥ 50 mg/5 min in each axilla, Axillary Sweating Daily Diary (ASDD) Item 2 severity score ≥ 4, and Hyperhidrosis Disease Severity Scale (HDSS) score ≥ 3 were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. The 4-item ASDD, 6 Weekly Impact (WI) items, Patient Global Impression of Change (PGIC), HDSS, and Dermatology Life Quality Index (DLQI) were utilized., Results: In the pooled population, 463 patients were randomized to GT and 234 to vehicle; 426 (92.0%) and 225 (96.2%) completed the trials. At baseline, most patients considered their axillary sweating to be at least moderate in severity, impact, and bothersomeness (ASDD items 2, 3, and 4, respectively). Improvement was substantially greater for GT than for vehicle at every study week, and, at week 4, ASDD scores improved from baseline by 62.6 versus 34.0% (severity), 65.5 versus 40.3% (impact), and 65.4 versus 39.0% (bothersomeness). Improvements favoring GT versus vehicle also occurred for WI items, PGIC, HDSS, and DLQI., Conclusions: PRO results demonstrated that GT reduced the disease burden of primary axillary hyperhidrosis., Trial Registration: Clinicaltrials.gov; ATMOS-1 (NCT02530281), ATMOS-2 (NCT02530294).

Background: OnabotulinumtoxinA and hyaluronic acid are effective in improving moderate to severe facial wrinkles and folds, with treatment selection traditionally based upon facial area., Objectives: This prospective, multicenter, open-label, crossover study evaluated physician-rated efficacy and patient-rated outcomes following moderate to severe facial wrinkles and folds treatment with onabotulinumtoxinA and hyaluronic acid., Methods: 152 subjects (25-65 years) were randomized (1:1) to a treatment-sequence of onabotulinumtoxinA/hyaluronic acid or hyaluronic acid/onabotulinumtoxinA, with initial treatment administered on day 1 and 6 additional visits: week 2 (touch-up); week 4 (crossover); week 6 (touch-up); and weeks 8, 12, and 24 (follow-up)., Results: Between 92% and 100% of subjects in each treatment-sequence group exhibited at least some improvement from baseline at each study visit in the Physician Aesthetic Improvement Scale and the Objective Observer and Patient Global Assessments of Improvement, with no significant between-sequence differences. Subjects reported looking 3 to 6 years younger at each visit, with significant improvements in glabellar, lateral canthal, and horizontal forehead lines, and nasolabial folds. Treatments were well tolerated., Conclusions: OnabotulinumtoxinA and hyaluronic acid provide clinically meaningful improvements as rated by physicians, objective observers, and subjects, with clinical synergy in aesthetic effects and duration of response regardless of treatment administration order in subjects seeking improvement in moderate to severe facial wrinkles and folds.

Objectives: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients., Methods: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups., Results: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation., Conclusions: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics., (© 2018 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)

Background: Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis., Objective: Assess the efficacy and safety of GT for primary axillary hyperhidrosis., Methods: ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 (severity of sweating) of the Axillary Sweating Daily Diary (ASDD), which is a newly developed patient-reported outcome measure, and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety evaluation included treatment-emergent adverse events., Results: Pooled data, which are consistent with the individual trial results, show that significantly more GT-treated patients achieved an ASDD-Item 2 response than did those treated with vehicle (59.5% vs 27.6%), and they had reduced sweat production from baseline (-107.6 mg/5 min vs -92.1 mg/5 min) at week 4 (P < .001 for both coprimary end points). Most treatment-emergent adverse events were mild or moderate and infrequently led to discontinuation., Limitations: Short trial duration and inherent challenges in gravimetrically assessing sweat production., Conclusions: GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Understanding interrelationships among aging facial features is important in facial aesthetics as a global treatment approach becomes standard., Objective: Examine empirical relationships between midface volume deficit and severity of tear troughs (TTs) and nasolabial folds (NLFs) in women and men of different racial/ethnic groups., Methods: A web-based study was administered to health panel members (aged 18-75 years). Participants compared their midface volume, TTs, and NLFs against photonumeric scales depicting degrees of severity. Linear regressions were conducted to assess the relationship of midface volume on severity of TTs and NLFs, controlling for demographic factors., Results: Of 4,086 participants (80.0% female), 3,553 had complete data. Increasing severity of midface volume deficit was associated with increasing severity of TTs and NLFs in both sexes (all p < .001). Race/ethnicity was associated with differences in severity in all 3 facial areas, although specific differences between races/ethnicities varied for women and men. Progression rates of severity differed between racial/ethnic groups. Correlations between midface volume deficit, TTs, and NLFs were positive and significant (all p < .001)., Conclusion: Midface volume deficit was associated with severity of TT deformity and NLFs after controlling for age and other demographic variables.

Background: As the demand for cosmetic treatments increases, it is important for dermatology residents to be educated about and achieve proficiency in dermatologic cosmetic procedures., Objective: To assess dermatology residents' educational exposure to cosmetic dermatology., Materials and Methods: An anonymous 18-question survey was sent electronically to 1,266 dermatology residents requesting information about cosmetic dermatology training during residency., Results: Two hundred sixty-eight residents responded to the survey (21% response rate). Most residents receive didactic instruction (94%) and hands-on training (91%) on cosmetic dermatology topics during residency. Survey participants in residency programs perceived as supportive of cosmetic dermatology training are more frequently provided lectures (70% vs 31%, p < .001) and procedural training (100% vs 69%, p < .001) in cosmetic dermatology as compared to residents in unsupportive programs. Eighty-nine percent of respondents reported hands-on training as the most effective method for developing proficiency in cosmetic procedures., Conclusion: Providing safe and competent patient care should serve as the impetus for expanding cosmetic dermatology education and training for residents.

Background: The trilobed flap is a useful repair option for distal nasal defects. In certain cases, however, the placement of its quaternary defect may risk compression of the internal nasal valve or induction of ectropion. In this study, we propose a modified design of the trilobed flap, which uses unequal external interlobe angles., Objective: To present the design principles and results of our modified trilobed flap for the reconstruction of difficult distal nasal Mohs defects., Materials and Methods: Mohs defects of 26 patients were reconstructed (21 with long-term follow-up) using our modified trilobed flap over 1 year. Two independent masked raters graded postoperative photographs for alar symmetry and overall cosmesis., Results: Median alar symmetry scores were excellent and overall cosmesis grades were between excellent and very good., Conclusion: The modified trilobed flap with unequal external angles offers an excellent option for reconstruction of Mohs defect of the distal nose that may not be well-suited for other repairs. Over 1 year, 21 modified trilobed repairs were performed with overall excellent outcomes.

Hyperhidrosis affects 4.8% of the US population, and despite the well documented negative impact of hyperhidrosis on patients' lives, data are generally lacking on the patient experience with this condition. The International Hyperhidrosis Society (IHHS) conducted a study in 2014, and initial results confirmed the multifaceted impact of hyperhidrosis on quality of life and underscored the need for disease awareness and effective management. To provide further insight into the hyperhidrosis patient experience, additional results focusing on family history, physician interaction, impact on daily activities, and treatment satisfaction are presented here. The online survey included 22 multiple-choice questions (some allowing multiple responses). Respondents were IHHS newsletter registrants in the US self-identified as suffering with excessive sweating (ie, answering 'yes' to Question 1). Of 28,587 survey invitations, a total of 5,042 recipients (17.6%) opened the e-mail, and 2,045 respondents provided an answer to Question 1. Of these, 1,985 (6.9%) self-identified as having excessive sweating and continued the survey. Over 18% of survey respondents reported an immediate family member with excessive sweating. The top three areas impacted by excessive sweating were daily activity, clothing choice, and work/career (average rank scores over 3.0 for each area; range 1-8 with lower scores indicating greater impact). Nearly half (48.9%) of respondents reported waiting 10 or more years prior to seeking medical help, and 85.0% waited at least 3 years. Of the 87.2% of respondents who received treatment for hyperhidrosis, patients were most satisfied with injections and least satisfied with prescription and over-the-counter antiperspirants and liposuction. These survey results add important clinical insight for the underserved hyperhidrosis patient population. The reported delay in seeking proper medical attention highlights the need to increase hyperhidrosis awareness among the public and clinicians, to reduce stigma associated with the condition, and to encourage active treatment strategies.

J Drugs Dermatol. 2018;17(4):392-396.

Background: There is a paucity of data on the prevalence of multifocal primary hyperhidrosis and changes in hyperhidrosis severity over time., Objective: The goal of this study was to better understand multifocal primary hyperhidrosis, prevalence and distribution of hyperhidrosis by focal site, age of onset of symptoms by focal area, and change in hyperhidrosis severity over time and with seasons., Materials and Methods: The International Hyperhidrosis Society, through an unrestricted research grant from Revance Therapeutics, conducted an online survey of registered visitors to its Web site. Participants identified as having "excessive sweating" and opted to participate in the survey (23 questions) after an e-mail invitation., Results: The survey data illustrate that multifocal primary hyperhidrosis is more common than previously believed and that multifocal hyperhidrosis is more common than singular focal hyperhidrosis (81% of patients reported 3 or more focal hyperhidrotic sites). The data also show that sweating symptom severity does not improve with age but stays the same or gets worse and is "bothersome" throughout the year., Conclusion: Recognition of the chronic and multifocal nature of primary hyperhidrosis is useful for treating hyperhidrosis patients long term and illustrates a need for treatments or treatment combinations that are effective for multiple body areas.

A variety of available treatment options are available for primary focal hyperhidrosis, and some can be combined to obtain maximum effective results. Most treatment options have only been studied in patients with axillary hyperhidrosis, and more studies are needed to develop therapies for other body regions. Several clinical trials are underway with promising preliminary results; however, there is still a large need for new therapies., (Copyright © 2016 Elsevier Inc. All rights reserved.)

ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) is the first aesthetic injectable approved for reduction of submental fat. In February 2014, an injection practicum was conducted in the anatomy laboratory at the University of Texas Southwestern Medical Center to explore the proper injection technique for ATX-101 and the importance of its appropriate, safe anatomical placement within the submental area. Subsequent to the injection practicum, a structured roundtable discussion was conducted in which potential implications of the various injection protocols evaluated during the practicum were reviewed. Furthermore, the faculty had the opportunity to provide additional perspectives based on their clinical experience with facial injectables and ATX-101 specifically. In this article, the findings from the injection practicum and roundtable discussion are reported.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for reduction of submental fat. Use of a pharmacologic/injectable therapy within the submental region requires a thorough understanding of cervicomental anatomy to ensure proper injection technique and safe administration. To this end, an anatomy laboratory was conducted to review key external landmarks and important internal anatomic structures that characterize the lower face and anterior neck. External landmarks that define the boundaries of the cervicomental and submental regions were identified including the inferior mandibular border, the anterior border of the sternocleidomastoid muscle, the antegonial notch, the submental crease, the thyroid notch, and the hyoid bone. Relevant internal anatomic structures, including preplatysmal submental fat (the target tissue for ATX-101) and the platysma muscle as well as critical neurovascular and glandular tissues were revealed by dissection. Of particular interest was the marginal mandibular branch of the facial nerve because it typically courses along the inferior mandibular border near the proposed treatment area for ATX-101.

Numerous nonsurgical options for periorbital rejuvenation are available and can be used alone or as adjuncts to other nonsurgical and surgical options. Topicals, chemical peels, laser resurfacing, and dermabrasion therapy, along with neuromodulators and fillers, can be used to enhance the appearance of the periorbital region., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: A plethora of surgical procedures have been promoted in the literature regarding the treatment of patella instability in the adolescent population; yet, none have compared the joint reaction forces of knee extensor mechanics after extensor mechanism realignment (Insall) or medial patellofemoral ligament reconstruction (MPFLR). The purpose of this study was to determine if there was a difference in knee extensor mechanics between these techniques., Methods: Three cohorts of 10 age-matched adolescents (normal control, Insall, and MPFLR) were compared using preoperative magnetic resonance imaging and postoperative x-ray in the 2 surgical groups. Patella and patella tendon length were measured and the actual moment arm calculated. Compression angles were estimated and the effective moment arms determined. Patellofemoral and quadriceps joint reaction forces were calculated. Comparisons within and between the 3 groups were determined and the dependent variables analyzed for statistical differences., Results: Mean ages (15.6±2.2 y), preoperative measures and dependent variables were not different between the groups (P>0.05). Postoperatively, there was a significant difference for the patellofemoral joint reaction force with respect to the quadriceps force (Fr/Fq), being larger within the Insall group (1.08±0.08) than the MPFLR group (0.92±0.09) (P<0.001). The postoperative MPFLR group variables were not significantly different to the control group. In contrast, the postoperative Insall group yielded larger joint reaction forces compared with control (1.08±0.08 vs. 0.83±0.11, P<0.001), as well as different effective moment arms, Insall versus control (51.23±8.8 vs. 41.9±5.9, P<0.001)., Conclusions: Not all surgical interventions for recurrent patella instability affect knee mechanics similarly. Although an extensor realignment procedure may still have indications in children, the treating surgeon should be aware that it does not appear to restore normal joint mechanics., Clinical Relevance: The Insall-type procedure may increase the patellofemoral joint reaction forces beyond normal without fully restoring the effective moment arms; whereas, MPFL reconstruction appears to restore the effective moment arm without excessive joint reaction forces.

Objective: To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis., Methods: This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed hyperhidrosis severity following the first two treatments using the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes., Results: Fifty-six (38.9%) participants underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. OnabotulinumtoxinA significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine patients (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of patients experienced a two-grade or more improvement at 4 and 8 weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152 days. Using quality of life measures, health outcomes improved markedly. Eight patients (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to onabotulinumtoxinA did not develop., Conclusion: OnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis., (© 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)

Background: Juvéderm Voluma XC (VYC-20L) is approved in the United States for correction of age-related volume loss in the midface region in adults., Objective: To characterize the effects of VYC-20L in 3 midface subregions based on injection volumes., Methods: In this single-blind controlled trial, subjects with midface volume deficit received VYC-20L in ≥1 of 3 facial subregions (zygomaticomalar, anteromedial cheek, and submalar), with touch-up treatment available 30 days later. Responders achieved ≥1-point improvement on the Mid-Face Volume Deficit Scale (MFVDS), analyzed by facial subregion and stratified by injection volume quartiles. Subject satisfaction and safety were assessed., Results: The treatment arm comprised 235 subjects aged 35 to 65 years. Month 6 MFVDS responder rates were 75.5% for zygomaticomalar, 83.2% for anteromedial cheek, and 76.9% for submalar subregions. Higher responder rates were observed with increasing injection volume quartiles for each subregion. Similar median injection volumes (≈2.0 mL total) of VYC-20L provided correction durations of 15 to 24 months: 24 months for anteromedial cheek, 19 months for zygomaticomalar, and 15 months for submalar subregions. Subject satisfaction was high across injection volume quartiles. No unanticipated treatment-site adverse reactions occurred., Conclusion: VYC-20L is effective at restoring midface volume, with high subject satisfaction and an acceptable safety profile.

Background: In a prior biomechanical study, 2-screw fixation of anatomically reduced slipped capital femoral epiphysis (SCFE) demonstrated marginally greater stability than single-screw fixation. However, the authors judged the benefits of a second screw to be minimal compared with the additional complication risk. A similar evaluation of fixation stability in unstable moderately displaced SCFE is performed., Methods: SCFE model: Transverse periosteal incision and epiphyseal separation from the metaphysis by leveraging in 25-month-old porcine femurs. Four groups were evaluated: pinned (3.5 mm cortex screws; Synthes, Monument, CO) with no displacement (1 screw=group N1; 2 screws=group N2) or with moderate posterior-inferior displacement of 50% of the epiphyseal diameter (1 screw=group D1; 2 screws=group D2). Biomechanical testing: Cyclical shear forces (40 to 200 N, 1 Hz) were applied along the physeal plane. Maximum load increased by 100 N every 500 cycles until failure (epiphyseal translation greater than one third the epiphyseal diameter). Force cycles (the sum of the maximum cycle loads) and number of cycles to failure were reported., Results: A sample from each D1 and D2 had fixation problems (D1, D2: n=4; N1, N2: n=5). One D1 failed through the femoral neck; all others failed through the epiphysis. The data showed nonsignificant trends of greater force cycles for nondisplaced over displaced (P=0.13) and for 2 screws over 1 (P=0.19). Number of cycles to failure showed similar trends, with no significant differences between nondisplaced and displaced (P=0.10) and screw number (P=0.13). Force cycles were significantly greater in the N2 group than in the D1 group., Conclusions: A trend toward higher force cycles to failure in nondisplaced and 2-screw groups was observed. Higher force cycles correspond to greater physeal stability and thus decreased risk for subsequent displacement. Within displacement groups, adding a second screw did not significantly increase stability. Reduction of displaced SCFE also did not significantly increase stability. Only the D1 and N2 groups were significantly different., Clinical Relevance: Nondisplaced SCFE does not require 2 screws. In situ fixation of displaced SCFE might be optimized with 2 screws.

Primary hyperhidrosis (excessive sweating) commonly affects the axillae, palms, soles, scalp, face, and the groin. Patients may have multiple areas involved making localized therapy challenging. Systemic therapy may be necessary and can be used as monotherapy or combined with other hyperhidrosis treatments for optimal outcomes. Systemic therapy can also be used to treat secondary hyperhidrosis and compensatory hyperhidrosis. Patient selection and counseling are key, and monitoring for side effects is required throughout therapy.

Background: Bimatoprost ophthalmic solution 0·03% is approved in several countries for the treatment of eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis., Objectives: To evaluate the long-term safety and efficacy of bimatoprost in patients with idiopathic or chemotherapy-induced hypotrichosis., Methods: This multicentre, double-masked, randomized, parallel-group study included two 6-month treatment periods [treatment period 1 (TP1) and treatment period 2 (TP2)]. Patients with idiopathic hypotrichosis were randomized to three treatment groups: (i) bimatoprost (TP1 and TP2); (ii) bimatoprost (TP1) and vehicle (TP2); and (iii) vehicle (TP1) and bimatoprost (TP2). Patients with chemotherapy-induced hypotrichosis were randomized to two treatment groups: (i) bimatoprost or vehicle (TP1) and (ii) bimatoprost (TP2). Primary end point was a composite of at least a one-grade improvement in investigator-assessed Global Eyelash Assessment and at least a three-point improvement in patient-reported Eyelash Satisfaction Questionnaire Domain 2 at month 4. Secondary measures included digitally assessed eyelash characteristics., Results: The primary efficacy end point was met in both populations (idiopathic responder rate was 40·2% for bimatoprost vs. 6·8% for vehicle; postchemotherapy responder rate was 37·5% for bimatoprost vs. 18·2% for vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (postchemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4-6 months following treatment cessation in patients with idiopathic hypotrichosis. No drug-related serious adverse events were reported., Conclusions: Daily treatment with bimatoprost ophthalmic solution 0·03% for 1 year was effective and well tolerated in patients with idiopathic and chemotherapy-induced hypotrichosis., (© 2014 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.)

Background: Observations that eyelashes become thinner, shorter, and lighter, as women age has not been previously quantified., Objective: This study was conducted to investigate associations between eyelash characteristics and age., Materials and Methods: The upper natural eyelashes of 179 subjects were photographed and analyzed (digital image analysis); length, thickness, and darkness (intensity: 0 = white and 255 = black) were calculated. Linear regression, including race as a potentially confounding factor, was used to assess the association between age and mean eyelash characteristics., Results: Subjects' mean age was 40.3 (±10.3) years; 46.1% were white, 36.5% Asian, 9.0% Hispanic, 5.1% East Indian, and 3.4% black. Mean eyelash length ranged from 6.39 (±1.02) to 7.98 (±1.15) mm (subjects aged 50-65 years and 22-29 years, respectively). Mean thickness ranged from 1.17 (±0.42) to 1.62 (±0.56) mm (subjects aged 50-65 years and 20-29 years, respectively). Mean intensity ranged from 118.2 (±19.8) to 129.4 (±17.3) (subjects aged 30-39 years and 50-65 years, respectively). Adjusted for race, eyelash length, thickness, and darkness decreased significantly with increasing age (p < .000, p = .0090, and p < .05, respectively)., Conclusion: Advancing age among an ethnically diverse population of healthy women is associated with significant decreases in eyelash length, thickness, and darkness.

Primary hyperhidrosis (HH) commonly affects the axillae, palms, soles, face, and/or the groin. There are limited treatment options available for HH of areas other than the axillae and palms/soles. Botulinum neurotoxin-A is an effective and safe treatment option for most hyperhidrotic areas of the body. Areas that are commonly affected, such as the face and groin, and less common areas like the submammary region and gluteal cleft are discussed. Frey syndrome, compensatory sweating, and postamputation stump HH are also discussed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

When medical options for axillary hyperhidrosis have failed, botulinum toxin is an effective, safe, and well-tolerated, although temporary, treatment option. For long-lasting or permanent efficacy, some patients turn to local procedures, such as superficial liposuction or manual curettage, or more invasive local surgery. Newer, minimally invasive treatments have become available, such as microwave energy thermolysis., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Primary hyperhidrosis commonly affects the axillae, palms, soles, scalp, face, and groin. Patients may have multiple areas involved making localized therapy challenging. Systemic therapy may be necessary and can be used as monotherapy or combined with other hyperhidrosis treatments for optimal outcomes. Systemic therapy can also be used to treat secondary hyperhidrosis and compensatory hyperhidrosis., (Copyright © 2014 Elsevier Inc. All rights reserved.)

New therapies are being investigated to treat hyperhidrosis. Novel methods of delivering botulinum toxins and new topical therapies have been developed. Devices that can deliver heat to the area of the eccrine units can reduce sweating. Further studies need to be performed., (Copyright © 2014 Elsevier Inc. All rights reserved.)

After tethered growth or sham surgery, spinal motion segments underwent microtomography to determine physeal and disc 3-dimensional (3D) morphology. Instrumented and contralateral sides of tether and sham surgical groups were compared., Objectives: To determine the 3D morphological effects of growth modulation via anterolateral tethering on vertebral physeal and intervertebral disc morphology in a rapidly growing bovine model., Summary of Background Data: Growth modulation acts through physeal loading. Providing a promising alternative to arthrodesis for scoliosis correction, tethering vertebral growth maintains further growth (open/functioning physes) and motion (disc integrity). Standard physeal and disc evaluation using histology reduces 3D geometries to single planar samples., Methods: Five-week-old calves received anterolateral flexible spinal tethers (n = 6) or sham surgeries (n = 6) followed by 6 months of growth. Individual motion segments were imaged by microtomograph (36 μm). Physeal space and disc space thickness maps were generated from surface reconstructions. Normalized thickness differences were compared between instrumented and contralateral sides of tether and sham groups (analysis of variance, p < .05). Physeal closure was estimated and regions of bony bridging were marked closed., Results: Tethering caused significant physeal thickness reduction on the instrumented side compared with the contralateral side (7.6% ± 2.0%; p = .0002). This reduction was greater (p = .003) in tethered physes than in the sham, which demonstrated no reduction (0.8% ± 3.7%; p = .6). Small regions of physeal closure were observed in sham and tether groups (medians of 1.4% and 0.1% and maximums of 6.8% and 2.7%, respectively). Tethered discs were 29% thinner than sham, but demonstrated no contralateral to instrumented-side thickness difference (5.2% difference; p = .3)., Conclusions: Tethering resulted in thinner physes on the tethered side without notable physeal closure. With no side differences in the sham group, tethering apparently applied instrument-sided compressive forces. Tethering also resulted in thinner discs, although they were apparently. Producing consistent histological samples is difficult; misaligned slices may lead to inaccurate conclusions. Evaluating entire physes or discs produces more robust results., (Copyright © 2013 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.)

Unlabelled: Negative pressure therapy (NPT), used on open wounds or postoperative infections, has not been evaluated on closed spinal incisions. This was analyzed after 3 days and 5 days of NPT application using biomechanics and histology in a porcine model., Methods: In 8 mature miniature pigs, 2 end-to-end midline spine incisions were closed in a standard fashion. Negative pressure (Prevena™ Incision Management System, KCI, San Antonio,TX) was applied to one incision (NPT group) while standard dry dressings were used on the other (control group). After 3 days or 5 days, all incisions underwent biomechanical (eg, failure load, failure energy, and stress), histological, and scar scale evaluation., Analysis: ANOVAs compared the groups (3-day vs 5-day, NPT vs control, P < 0.05). Negative pressure therapy demonstrated a significantly improved scar scale height grade than the control (P = 0.026). Failure load (4.9 ± 4.0 vs 16.5 ± 14.6 N), energy absorbed (8.0 ± 9.0 vs. 26.9 ± 23.0 mJ), and ultimate stress (62 ± 53 vs. 204 ± 118 N/mm2) were lower in the control group. Histological analysis revealed no differences in incision scar width., Conclusion: Negative pressure therapy application on closed incisions presented a trend toward improved early healing strength, and in significantly improved incision appearance. Clinically, NPT may improve incision integrity, minimizing the risk of dehiscence or subsequent infection. Patients at high risk of postoperative incision site complications may benefit from primary application of NPT.

Purpose: Anterior spinal stapling for the treatment of adolescent idiopathic scoliosis has been shown to slow progression in small curves; however, its role in larger curves remains unclear. The purpose of this study was to evaluate the effectiveness of nitinol staples to modulate spinal growth by evaluating the two-dimensional and three-dimensional morphological and histological effects of this method in a well-established porcine model., Methods: Three immature Yucatan miniature pigs underwent intervertebral stapling. Two staples spanned each of three consecutive mid-thoracic discs and epiphyses. Monthly radiographs were obtained. Computed tomography (CT) was conducted at harvest after 6 months of growth. Measurements of wedging and height for each disc and vertebral body were conducted. Micro CT was used to compare physeal closure between stapled and non-stapled levels. Histology of the growth plate also compared the hypertrophic zone thickness for control and stapled vertebrae., Results: After 6 months of stapled growth, the average coronal Cobb angle of the stapled segments increased by 7.7 ± 2.0° and kyphosis increased by 3.3 ± 0.6° compared to preoperative curves. Increased vertebral wedging and decreased disc height (p < 0.001) were noted in stapled regions. Overall, 26 ± 23 % of each growth plate was closed in the stapled segments, with 6 ± 8 % closure in the unstapled levels. No difference was observed regarding the hypertrophic zone height when comparing instrumented to uninstrumented levels, nor was a difference recognized when comparing right versus left regions within stapled levels alone., Conclusions: Six months of nitinol intervertebral stapling created a mild coronal and sagittal deformity associated with reduced vertebral and disc height, and increased coronal vertebral and sagittal disc wedging.

Background: Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested., Study Design/materials and Methods: Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group)., Results: Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time., Conclusions: The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future., (© 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)