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Background: Injectable biostimulators are widely used to improve facial aging signs. This study was performed to compare the genetic pathways affected by 2 different injectable biostimulators., Methods: Randomized 13-week study (n = 21) comparing gene expression after poly l-lactic acid (PLLA-SCA) and calcium hydroxylapatite (CaHA-R) injections (baseline [BL] and Day 28) as treatment of nasolabial fold wrinkles. Punch biopsy was performed at BL and day 90; RNA was isolated, gene expression was analyzed, and bulk RNA sequencing performed. Data from both pathways were studied using the Search Tool for Retrieval of Interacting Genes/Proteins and Reactome databases., Results: Analysis at Day 0 and Day 90 showed differing gene regulation for PLLA-SCA and CaHA-R (after accounting for minor differences at BL, p < .05 at Day 90 for 9-12 genes). PLLA-SCA uniquely correlates with genes involved in adipocyte regeneration, while CaHA-R did not affect these genes. Clinically, this could translate to healthy fat replacement with an enhanced effect beyond the improvement of the collagen structure and a longer-lasting effect with PLLA-SCA. Furthermore, the adipokines that appear to be upregulated are regenerative with a positive impact on skin health., Conclusion: PLLA-SCA has a novel and unique signature, which supports a potential regenerative mechanism of action through its role in the modulation of adipocyte function., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: For three decades, fractional ablative CO 2 lasers have been used for skin rejuvenation. With breakthroughs in laser technology and expanding popularity, new recommendations and suggestions arise on a regular basis., Objective: To develop up-to-date clinical recommendations on safety measures, therapeutic framework, and techniques to improve treatment outcomes., Methods: Using Google Forms, a questionnaire with 188 questions was given to a varied sample of 21 dermatologists and plastic surgeons from various countries and practice contexts. A second questionnaire with 11 items was created to resolve any gaps or discrepancies., Results: Active face infections are considered a treatment contraindication by 95% of panelists. Burns, recent sun exposure, and pregnancy or breastfeeding were also considered contraindications (according to 67% of panelists). Over 90% employ bacterial and viral prophylaxis, however the majority (67%) do not prescribe antifungal prophylaxis. The most often stated anesthetic treatments by panelists are topical anesthetic cream, nerve blocks, and oral analgesics (according to 95%, 81%, and 62% of panelists respectively). Over 90% of panel members suggested treatment setting alterations for individuals with Fitzpatrick skin types III-IV. Following reepithelization, which happens between 8 and 42 days after the treatment, the majority (76%) of panelists advocate continuing standard skin care routines including active ingredients. Eighty-one percent of panelists recommend using supplementary treatment to maximize results. Supplementary treatment recommendations included use of neuromodulators (76% of panelists), Intense Pulsed Light Therapy treatments pre and postprocedure (61% of panelists), and injection-based therapies such as (Hyaluronic Acid fillers, and biostimulatory fillers) (recommended by 48% of panelists). 60% of panelists perform FACL to improve skin laxity treatment in nonfacial areas and adjust their settings accordingly., Limitations: Our results reflect only a modest panel size; with a focus on a specific device. Although experienced, the small number of panelists, recommendations, and personal adverse reactions encounters for resurfacing indication, might be biased., Conclusion: Fractional CO 2 laser is a popular and effective skin rejuvenation treatment with minimal downtime and side effects. This study presents new therapy recommendations to resolve treatment uncertainty and provide complete care suggestions for best results., (© 2024 The Author(s). Lasers in Surgery and Medicine published by Wiley Periodicals LLC.)

Background: Vitiligo lesions are often challenging to repigment with conventional medical therapies. Surgical autologous melanocyte transfer methods can be utilized for stable vitiligo but demand specialized skills and equipment. A point-of-care autologous cell harvesting device was designed enabling simple preparation of autologous skin cell suspension (ASCS) containing melanocytes, keratinocytes, and fibroblasts providing a straightforward approach for cellular transplantation., Objective: To evaluate the safety and effectiveness of ASCS for repigmentation of stable vitiligo lesions among adults., Methods: A US multicenter, randomized, within-subject controlled trial compared ASCS to narrow band ultraviolet B only (Control) in similar vitiligo lesions. ASCS was applied after laser skin resurfacing and followed by narrow band ultraviolet B treatment. The primary effectiveness endpoint was the proportion of lesions achieving ≥80% repigmentation at week-24. Repigmentation durability was assessed at week-52., Results: Among 25 subjects, 36% of ASCS-treated lesions achieved ≥80% repigmentation at week-24 compared to 0% for Control (P < .025), with durability through week-52. The safety profile of ASCS was acceptable, with favorable patient- and investigator-reported outcomes., Limitations: Study sample size limited robust subgroup analyses., Conclusion: Application of ASCS has potential as a treatment for repigmentation of stable vitiligo lesions with the potential to improve health-related quality of life and reduce burden of disease., Competing Interests: Conflicts of interest Dr Hamzavi has served as an advisory board member for AbbVie; a consultant for Boehringer Ingelheim, AVITA Medical, Galderma Laboratories LP, Incyte, Pfizer, and UCB; a principal investigator for AVITA, Bayer, Estée Lauder, Ferndale Laboratories, Incyte Corporation, Lenicura, L’Oréal, Pfizer, and Unigen; immediate past president of the HS Foundation; and a board member of the Global Vitiligo Foundation. Dr Ganesan is an investigator for AVITA and AbbVie. Dr Mahmoud is an investigator for AVITA. Dr Munavalli is an investigator and speaker for AVITA. Dr Kahn is an investigator and speaker for AVITA and Vericel Inc, a DSMB consultant for Polynovo, and an investigator and medical monitor for Spectral MD. Dr Huang has served on an advisory panel for Incyte and as an investigator for Abbvie. Dr Waibel has served as an advisory board member for Bellamia, Cytrellis Biosystems, and RegenX; a consultant for Allergan, Candela, Cytrellis Biosystems, P&G, Skinceuticals, and Turn.Bio; an investigator for Amgen, ArgenX, Bristol Myers Squibb, Cytrellis Biosystems, Eli Lily, Emblation, Galderma, Horizon, Janssen, Neuronetics, Pfizer, RegenX, Sanofi, Skincueticals, and Shanghi Biopharma, PWB; a speaker for Candela and Eli Lily; she has received a Veterans Affairs Merit Grant - Amputated Veterans. Dr Elbuluk has served as a consultant, advisory board member, and/or speaker for AVITA, Incyte, VisualDx, La Roche Posay, Beiersdorf, Unilever, Allergan, Eli Lilly, Galderma, Pfizer, Takeda, AbbVie, Janssen, Sanofi, L’Oreal, McGraw Hill, Dior, Medscape; she has grant funding from Pfizer, has received royalties from McGraw-Hill and has stock options in VisualDx. Dr Pandya has served as an investigator for Incyte, AVITA, Clinuvel; a consultant for AbbVie, AVITA, Boehringer Ingelheim, Immune Tolerance Network, Incyte, Lilly, Pfizer, Sun, Thalocan, WCG, Villaris, Vimela, Vyne; and has partial owndership of Tara Medical. Drs Weiss, Ahmed, Robinson, Goldman, A. Desai and S. Desai have no conflicts of interest to declare., (Copyright © 2024 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)

Acne can cause disfiguring sequelae, such as scarring, post-inflammatory erythema (PIE), and post-inflammatory hyperpigmentation (PIH). These post-inflammatory dyschromias pose a significant psychological burden on patients. This burden disproportionately affects skin of color (SOC) patients and can be the most distressing aspect of acne in SOC patients with skin types IV to VI. Multiple non-ablative lasers are used in the treatment of acne-related PIE and PIH. Combination therapies have shown promise in conditions such as rosacea, acne, and post-inflammatory dyschromia. Addressing both the inflammatory and scarring components of acne is key. Given the role of oxidation in the inflammatory cascade, including antioxidants could be an efficacious adjuvant with non-ablative lasers. This is a single-site, randomized, controlled clinical study of 25 subjects with skin types I to VI with facial PIE and/or PIH from acne. The primary objective was to investigate the clinical efficacy of non-ablative laser therapy followed by the topical application of Silymarin/Salicylic Acid/L-Ascorbic Acid/Ferulic Acid (SSAF) or control in the improvement in oily skin patients with facial PIE and PIH due to acne lesions. There was a statistically significant decrease in PIH and intralesional melanin in patients treated with a combination SSAF and non-ablative laser therapy. Improvement of both PIE and PIH was augmented in combination with SSAF and laser-treated patients compared with the laser-only group, with a concomitant increase in collagen density. This was even more strikingly marked in the SOC subjects, potentially providing an energy-based device (EBD)-based therapy in this population. Limitations of this study include small sample size and length of post-treatment follow-up. J Drugs Dermatol. 2024;23(9):769-773. doi:10.36849/JDD.8309.

The inflammatory burden as measured by high-sensitivity C-reactive Protein (hsCRP) is recognized as a cardiovascular risk factor, which can however be affected by lifestyle-related risk factors (LRF). Up-to-date the interplay between hsCRP, LRF and presence and extent of atherosclerotic disease is still largely unknown, which we therefore sought to investigate in a contemporary population-based cohort. We included participants from the cross-sectional population-based Hamburg City Health Study. Affected vascular beds were defined as coronary, peripheral, and cerebrovascular arteries. LRF considered were lack of physical activity, overweight, active smoking and poor adherence to a Mediterranean diet. We computed multivariable analyses with hsCRP as the dependent variable and LRF as covariates according to the number of vascular beds affected. In the 6765 individuals available for analysis, we found a stepwise increase of hsCRP concentration both according to the number of LRF present as well as the number of vascular beds affected. Adjusted regression analyses showed an independent association between increasing numbers of LRF with hsCRP levels across the extent of atherosclerosis. We demonstrate increasing hsCRP concentrations according to both the number of LRF as well as the extent of atherosclerosis, emphasizing the necessity of lifestyle-related risk factor optimization., (© 2023. The Author(s).)

Gold microparticles are indicated as an accessory to 1064 nm lasers to facilitate photo-thermal heating of sebaceous glands for treating mild-to-moderate inflammatory acne vulgaris (Sebacia Microparticles, Coronado Aesthetics LLC, Southlake, TX). The following study assessed the safety and clinical benefit of gold microparticles/laser therapy when used together with commercially available topical acne products. Healthy patients, 12 to 45 years old with mild-to-moderate inflammatory facial acne were prescribed a topical pre-treatment retinoid for 3 to 4 weeks. The gold microparticle suspension was then applied to the entire face and massaged into the skin. The laser procedure was performed with commercially available 1064 nm Nd:YAG lasers with fluence in the 20 to 35 J/cm2 range, a 30 ms pulse duration, and direct cooling. Among participants completing the study (N=52), the mean percent change in inflammatory lesion counts (ILC) was -55% at month 2, reaching -68% at month 12. At that time, 86% of participants achieved a 40% decrease in ILC and 75% achieved a 60% decrease in ILC. Mean Investigator's Global Assessment (IGA) Scale scores decreased by 41.6% from 2.4 at day 0 to 1.4 at month 12. The percentage of participants with clear or almost clear skin increased from 7% at day 0 to 59% at month 12. Acne therapy with topically applied gold microparticles followed by 1064 nm laser irradiation is an effective treatment for moderate to moderately severe acne. The treatment was well-tolerated with a high degree of participant satisfaction. J Drugs Dermatol. 2023;22(11):1088-1094&nbsp; &nbsp;&nbsp; doi:10.36849/JDD.7744.

Background: Five modifiable risk factors are associated with cardiovascular disease and death from any cause. Studies using individual-level data to evaluate the regional and sex-specific prevalence of the risk factors and their effect on these outcomes are lacking., Methods: We pooled and harmonized individual-level data from 112 cohort studies conducted in 34 countries and 8 geographic regions participating in the Global Cardiovascular Risk Consortium. We examined associations between the risk factors (body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes) and incident cardiovascular disease and death from any cause using Cox regression analyses, stratified according to geographic region, age, and sex. Population-attributable fractions were estimated for the 10-year incidence of cardiovascular disease and 10-year all-cause mortality., Results: Among 1,518,028 participants (54.1% of whom were women) with a median age of 54.4 years, regional variations in the prevalence of the five modifiable risk factors were noted. Incident cardiovascular disease occurred in 80,596 participants during a median follow-up of 7.3 years (maximum, 47.3), and 177,369 participants died during a median follow-up of 8.7 years (maximum, 47.6). For all five risk factors combined, the aggregate global population-attributable fraction of the 10-year incidence of cardiovascular disease was 57.2% (95% confidence interval [CI], 52.4 to 62.1) among women and 52.6% (95% CI, 49.0 to 56.1) among men, and the corresponding values for 10-year all-cause mortality were 22.2% (95% CI, 16.8 to 27.5) and 19.1% (95% CI, 14.6 to 23.6)., Conclusions: Harmonized individual-level data from a global cohort showed that 57.2% and 52.6% of cases of incident cardiovascular disease among women and men, respectively, and 22.2% and 19.1% of deaths from any cause among women and men, respectively, may be attributable to five modifiable risk factors. (Funded by the German Center for Cardiovascular Research (DZHK); ClinicalTrials.gov number, NCT05466825.)., (Copyright © 2023 Massachusetts Medical Society.)

Biomechanical simulation allows for in silico estimations of biomechanical parameters such as muscle, joint and ligament forces. Experimental kinematic measurements are a prerequisite for musculoskeletal simulations using the inverse kinematics approach. Marker-based optical motion capture systems are frequently used to collect this motion data. As an alternative, IMU-based motion capture systems can be used. These systems allow flexible motion collection without nearly any restriction regarding the environment. However, one limitation with these systems is that there is no universal way to transfer IMU data from arbitrary full-body IMU measurement systems into musculoskeletal simulation software such as OpenSim. Thus, the objective of this study was to enable the transfer of collected motion data, stored as a BVH file, to OpenSim 4.4 to visualize and analyse the motion using musculoskeletal models. By using the concept of virtual markers, the motion saved in the BVH file is transferred to a musculoskeletal model. An experimental study with three participants was conducted to verify our method's performance. Results show that the present method is capable of (1) transferring body dimensions saved in the BVH file to a generic musculoskeletal model and (2) correctly transferring the motion data saved in the BVH file to a musculoskeletal model in OpenSim 4.4.

Does competition affect moral behavior? This fundamental question has been debated among leading scholars for centuries, and more recently, it has been tested in experimental studies yielding a body of rather inconclusive empirical evidence. A potential source of ambivalent empirical results on the same hypothesis is design heterogeneity-variation in true effect sizes across various reasonable experimental research protocols. To provide further evidence on whether competition affects moral behavior and to examine whether the generalizability of a single experimental study is jeopardized by design heterogeneity, we invited independent research teams to contribute experimental designs to a crowd-sourced project. In a large-scale online data collection, 18,123 experimental participants were randomly allocated to 45 randomly selected experimental designs out of 95 submitted designs. We find a small adverse effect of competition on moral behavior in a meta-analysis of the pooled data. The crowd-sourced design of our study allows for a clean identification and estimation of the variation in effect sizes above and beyond what could be expected due to sampling variance. We find substantial design heterogeneity-estimated to be about 1.6 times as large as the average standard error of effect size estimates of the 45 research designs-indicating that the informativeness and generalizability of results based on a single experimental design are limited. Drawing strong conclusions about the underlying hypotheses in the presence of substantive design heterogeneity requires moving toward much larger data collections on various experimental designs testing the same hypothesis.

Importance: Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD., Objective: To develop recommendations for the safe and effective use of LADD., Evidence Review: A systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved., Findings: Of the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline's 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections., Conclusions and Relevance: This systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.

Objectives: Evidence suggests that precarious employment can have detrimental effects on workers' health, including mental health. Migrant workers are discussed to be especially vulnerable to such effects. Thus, we systematically reviewed existing research on the association between precarious employment and migrant workers' mental health., Methods: Three electronic databases (Web of Science, PsycINFO and PubMed/Medline) were searched for original articles on quantitative and qualitative studies published from January 1970 to February 2022 in English, German, Turkish and Spanish. Multiple dimensions of precarious employment were considered as exposure, with mental health problems as outcomes. Narrative synthesis and thematic analyses were performed to summarize the findings of the included studies along with risk of bias and quality assessment., Results: The literature search resulted in 1557 original articles, 66 of which met the inclusion criteria - 43 were of high quality and 22 were of moderate quality. The most common exposure dimensions analyzed in the studies included temporariness, vulnerability, poor interpersonal relationships, disempowerment, lacking workers' rights and low income. The outcome measures included stress, depression, anxiety and poor general mental health. The prevalence of these outcomes varied between 10-75% among the included quantitative studies. All qualitative studies reported one or more dimensions of precarious employment as an underlying factor of the development of mental health problems among migrants. Of 33 quantitative studies, 23 reported evidence for an association between dimensions of precarious employment and mental health., Conclusion: The results of this review support the hypothesis that precarious employment is associated with migrant workers' mental health.

Background: Choosing an antipsychotic medication is an important medical decision in the treatment of schizophrenia. This decision requires risk-benefit assessments of antipsychotics, and thus, shared-decision making between physician and patients is strongly encouraged. Although the efficacy and side-effect profiles of antipsychotics are well-established, there is no clear framework for the communication of the evidence between physicians and patients. For this reason, we developed an evidence-based shared-decision making assistant (SDM-assistant) that presents high-quality evidence from network meta-analysis on the efficacy and side-effect profile of antipsychotics and can be used as a basis for shared-decision making between physicians and patients when selecting antipsychotic medications., Methods: The planned matched-pair cluster-randomised trial will be conducted in acute psychiatric wards (n = 14 wards planned) and will include adult inpatients with schizophrenia or schizophrenia-like disorders (N = 252 participants planned). On the intervention wards, patients and their treating physicians will use the SDM-assistant, whenever a decision on choosing an antipsychotic is warranted. On the control wards, antipsychotics will be chosen according to treatment-as-usual. The primary outcome will be patients' perceived involvement in the decision-making during the inpatient stay as measured with the SDM-Q-9. We will also assess therapeutic alliance, symptom severity, side-effects, treatment satisfaction, adherence, quality of life, functioning and rehospitalizations as secondary outcomes. Outcomes could be analysed at discharge and at follow-up after three months from discharge. The analysis will be conducted per-protocol using mixed-effects linear regression models for continuous outcomes and logistic regression models using generalised estimating equations for dichotomous outcomes. Barriers and facilitators in the implementation of the intervention will also be examined using a qualitative content analysis., Discussion: This is the first trial to examine a decision assistant specifically designed to facilitate shared-decision making for choosing antipsychotic medications, i.e., SDM-assistant, in acutely ill inpatients with schizophrenia. If the intervention can be successfully implemented, SDM-assistant could advance evidence-based medicine in schizophrenia by putting medical evidence on antipsychotics into the context of patient preferences and values. This could subsequently lead to a higher involvement of the patients in decision-making and better therapy decisions., Trial Registration: German Clinical Trials Register (ID: DRKS00027316 , registration date 26.01.2022)., (© 2022. The Author(s).)

Introduction: Baricitinib, an oral Janus kinase (JAK)1/JAK2 inhibitor, is indicated in the European Union and Japan for treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. In the ongoing, placebo-controlled, phase 3 trial BREEZE-AD5, once-daily oral baricitinib 2-mg monotherapy improved disease in moderate-to-severe AD patients who had an inadequate response or intolerance to topical corticosteroids. This post-hoc analysis aimed to identify responders to baricitinib 2 mg, using a proposed clinical tailoring approach based on baseline body surface area (BSA) affected and early clinical improvement, in BREEZE-AD5., Methods: Classification and regression tree method was used to evaluate baseline predictors for the proportion of patients achieving ≥ 75% improvement in Eczema Area and Severity Index (EASI75) at week 16 among baricitinib 2-mg-treated patients. Two-by-two contingency tables evaluated the association between early response, defined as ≥ 50% improvement in BSA or ≥ 3-point improvement in Itch Numeric Rating Scale from baseline at weeks 4 or 8, and response at week 16 for the proportion of patients achieving EASI75, validated Investigator Global Assessment for AD (vIGA-AD) score of 0 or 1, or ≥ 4-point improvement in Itch (Itch ≥ 4), respectively. Missing data were imputed as non-responder., Results: At week 16, EASI75 and vIGA-AD (0,1) were achieved by 37.5% and 31.7% of baricitinib 2-mg-treated patients with baseline BSA 10-50% compared with 9.5% and 4.8% with BSA > 50%. Early response in skin inflammation or itch at week 4 was associated with corresponding EASI75, vIGA-AD (0,1), and Itch ≥ 4 of 55.4%, 48.2%, and 39.3% at week 16, while early response at week 8 was associated with 66.7%, 56.1%, and 42.1% of patients achieving these endpoints., Conclusion: Baseline BSA of 10-50% and early clinical improvement after 4 or 8 weeks of baricitinib 2-mg treatment may identify patients most likely to benefit from long-term baricitinib 2-mg therapy., Clinical Trial Registration: NCT03435081., (© 2021. The Author(s).)

Background and Objectives: Acne scars are one of the most distressing and long-term consequences of acne vulgaris, with damaging effect on a person's physical, mental, and social well-being. Numerous treatment options are available including surgical and nonsurgical techniques, depending on the clinical presentation. Although considerable advances in the development of new treatment technologies and applications have been made in the last decade, international treatment guidelines and reimbursement schemes have not yet caught up with current knowledge and practice in many centers. The authors intend to highlight the potential utility of energy-based devices (EBDs) for acne scarring, offer recommendations for safe and efficacious treatment, and provide consensus-based EBD treatment options based on varying presentations demonstrated in a series of real-life clinical photographs., Study Design/materials and Methods: An international panel of 24 dermatologists and plastic surgeons from 12 different countries and a variety of practice backgrounds was self-assembled to develop updated consensus recommendations for the treatment of acne scars. A two-step modified Delphi method took place between March 2020 and February 2021 consisting of two rounds of emailed questionnaires. The panel members approved the final manuscript via email correspondence., Results: The manuscript includes a comprehensive discussion and panel recommendations regarding the following topics: 1. the role of EBD in mitigating and treating acne scars in a patient with active acne, 2. the use of various EBDs for the treatment of different acne scar types with special focus on commonly used laser platform such as vascular lasers, ablative fractional lasers (AFLs) and non-AFLs (NAFLs), 3. treatment combinations, and 4. acne scar treatments in skin of color. The last part comprised of 10 photos of real-life clinical cases with the panel recommendation treatment plan to achieve best aesthetic outcome., Conclusion: Panel members were unanimous in their view that EBDs have a role in the management of acne scars, with AFLs, NAFLs, vascular lasers, and RF devices preferentially selected by most of the panel experts. EBDs are considered a first-line treatment for a variety of acne scar types and patients without access to these treatments may not be receiving the best available care for optimal cosmetic results. Future high-quality research and updated international treatment guidelines and reimbursement schemes should reflect this status., (© 2021 Wiley Periodicals LLC.)

Introduction: Scars are the end result of a biologic and natural process of wound repair after injury, surgery, acne, illness, burns, and infection. When skin is damaged, a fast and coordinated body response is triggered by four highly integrated and overlapping phases including homeostasis, inflammation, proliferation, and tissue remodeling. Healing of a skin wound may result in an abnormal scar if the balance among these four phases is lost during the healing process. Various topical treatments have been used for their ability to reduce unsightly scar formation. Recently, studies have shown improvement in scar appearance after treating with silicone gels containing natural herbal ingredients. The aim of this study is to evaluate the efficacy of a novel silicone-based gel containing copaiba oil (Copaderm) for prevention and/or appearance reduction of different types of abnormal scars., Methods: This study was designed as a prospective, randomized, double-blind, placebo-controlled trial involving 42 patients with abnormal scars, divided into two groups. Each group received either a topical scar formulation consisting of copaiba oil in silicone gel or a placebo gel twice a day for 84 days. Assessments of the scars were performed at 0, 28, and 84 days following the onset of topical application using three methods: a clinical assessment using the Manchester Scar Scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire., Results: Of the original 42 patients, 32 completed the evaluation. There was a significant difference with respect to the overall score of the Manchester Scar Scale between the two groups from baseline to 84 days (P < 0.05). All patients with copaiba oil in silicone gel achieved improvement of their scars, based on overall score at 84 days. A visible scar reduction was observed with photographic assessment. Eighty-nine percent of subjects (n = 16) with copaiba oil in silicone gel rated as being satisfied or very satisfied after 84 days of treatment., Conclusion: Our findings support the hypothesis that copaiba oil in silicone-derivative gel was able obtain significant improvement in color, contour, distortion, and texture for different types of scar through the Manchester Scar Scale analysis. These findings contribute to reducing abnormal scar formation during the healing process., (© 2021. The Author(s).)

Background: Fractional laser treatment was introduced in 2004 as a non-invasive technique to treat sun-damaged and aging skin. Since then, numerous ablative and non-ablative photothermolysis technologies and devices have been introduced, increasing the options for clinicians and patients but also increasing the complexity regarding which system to use and the techniques to optimize outcomes. No two devices are the same and the user-manuals preset dosimetry does not address many clinical situations, which can create confusion for new and inexperienced users., Methods: An online survey addressing use of a 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser was sent to eight (8) US board certified dermatologists with extensive experience in the use of the device. The survey included 39 questions, addressing experience, best practices and recommendations for use., Results: The survey data suggests that the device can be used to treat patients of all ages and skin types for indications including photoaging and photodamage, periorbital wrinkles, freckles, (ephelides), solar lentigines, poikiloderma, scarring due to acne or surgery. It can be used on both facial and non-facial areas, including neck, chest, hands, arms, abdomen, legs, and buttocks. Unexpected and adverse effects were rarely reported and those that did were mild and transient., Conclusions: This position paper provides practical real-world guidelines resulting from a small survey of experienced users, for new and early uses of the novel 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser. J Drugs Dermatol. 2021;20(11):1150-1157. doi:10.36849/JDD.6181.

Background: Baricitinib, an oral selective Janus kinase 1/Janus kinase 2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults., Objective: To evaluate the efficacy and safety of baricitinib monotherapy in a North American phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy., Methods: Patients (N = 440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index at week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD score of 0 (clear)/1(almost clear) with ≥2-point improvement., Results: At week 16, the proportion of patients achieving Eczema Area and Severity Index was 8%, 13%, and 30% (P < .001, 2 mg vs placebo) and those with a validated Investigator Global Assessment for AD score of 0/1 were 5%, 13%, and 24% (P < .001, 2 mg vs placebo) for placebo, baricitinib 1 mg, and baricitinib 2 mg, respectively. Safety findings were similar to those of other baricitinib AD studies., Limitations: Short-term clinical trial results may not be generalizable to real-world settings., Conclusion: Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks., Competing Interests: Conflicts of interest Dr Simpson reports grants and fees for participation as a consultant and principal investigator from Eli Lilly and Company, LEO Pharma, Pfizer, and Regeneron; grants for participation as a principal investigator from Galderma and Merck & Co; and fees for consultant services from AbbVie, Boehringer Ingelheim, Dermavant Incyte, Forte Bio, Pierre Fabre Dermo, and Sanofi Genzyme. Dr Forman is a consultant, investigator, advisory board member, and/or speaker for and receives funding and/or honoraria from AbbVie, Aclaris Therapeutics Inc, Asana BioSciences, AstraZeneca, Athenex, Celgene Corporation, Cutanea Life Sciences, Eli Lilly and Company, Incyte Corporation, Innovaderm Research Inc, Novartis, Pfizer Inc, Promius Pharma LLC, Regeneron, UCB, Valeant Pharmaceuticals North America LLC, and XBiotech. Dr Silverberg served as a consultant and/or advisory board member for AbbVie, Arena, Asana, Bluefin, Boehringer Ingelheim, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa, Leo, Luna, Novartis, Pfizer, RAPT, Regeneron, and Sanofi, receiving honoraria; served as a speaker for Regeneron-Sanofi; and received research grants from Galderma. Dr Zirwas is a consultant, investigator, and/or speaker for Regeneron, Sanofi, Genench, Novartis, L'Oreal, Menlo, Leo, Eli Lilly and Company, Ortho Derm, and Arcutis and is a part owner of AsepticMD. Dr Han is a consultant for Eli Lilly and Company, Regeneron, Sanofi, and Pfizer. Dr Guttman-Yassky is a consultant for AbbVie, Almirall, Amgen, Asana Biosciences, Boehringer Ingelhiem, Cara Therapeutics, Celgene, Concert, DBV, Dermira, DS Biopharma, Eli Lilly and Company, EMD Serono, Escalier, Galderma, Glenmark, Kyowa Kirin, LEO Pharma, Mitsubishi Tanabe, Pfizer, RAPT Therapeutics, Regeneron, Sanofi, Sienna Biopharma, and Union Therapeutics and reports institute grants for research from AbbVie, Almirall, Amgen, AnaptysBio, Asana Biosciences, Boehringer Ingelhiem, Celgene, Dermavant, DS Biopharma, Eli Lilly and Company, Glenmark, Galderma, Innovaderm, Janssen, Kiniska, Kyowa Kirin, Leo Pharma, Novan, Pfizer, Ralexar, Regeneron, Sienna Biopharma, UCB, and Union Therapeutics. Dr Bissonnette is an advisory board member, consultant, speaker and/or investigator for and receives honoraria and/or grant from AbbVie, Arcutis, Arena Pharma, Asana BioSciences, Bellus Health, Boehringer Ingelheim, CARA, Dermavant, Eli Lilly, EMD Serono, Galderma, Incyte, Kiniksa, Kyowa Kirin, LEO Pharma, Novan, Pfizer, Ralexar, RAPT, Regeneron, Sanofi Genzyme, and Sienna and is an employee and shareholder of Innovaderm Research. Dr Waibel is an investigator, consultant speaker for, and/or receives honoraria from AbbVie, Pfizer, Candela, Cytrellis, Dominion, Eli Lilly and Company, Novartis, Sebacia, and Sciton. Dr Papp is a consultant, speaker, investigator, scientific officer, steering committee member, and/or advisory board member for AbbVie, Akros, Amgen, Anacor, Arcutis, Astellas, Bausch Health/Valeant, Baxalta, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly and Company, Evelo, Galapagos, Galderma, Genentech, Gilead, GSK, Janssen, Kyowa Hakko Kirin, Leo, Medimmune, Meiji Seika Pharma, Merck (MSD), Merck- Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, UCB. Drs Nunes, Holzwarth, and Janes and authors DeLozier and Angle are employees and shareholders of Eli Lilly and Company. Drs Gamalo and Goldblum were employees of Eli Lilly and Company during the study. Drs Maverakis and Marnell and author Zhong have no conflicts of interest to declare., (Copyright © 2021. Published by Elsevier Inc.)

Background: Precarious employment has become an urgent public health issue at a global scale with potential consequences for quality of life and health of employees, especially in vulnerable groups such as migrants. The primary aim of this systematic review is thus to analyze and summarize existing research on the association between precarious employment and migrant workers' mental health., Methods: We will search PubMed/MEDLINE, PsycINFO, Web of Science (from January 1970 onwards) for original articles on observational studies (e.g., cohort, case-control and cross-sectional, and qualitative) published in English, German, Turkish, and Spanish. The primary outcome will be depression and anxiety disorders. Secondary outcomes will be burnout, sleeping problems, and occupational stress. Two reviewers will independently screen all citations, full-text articles, and abstract data. Potential conflicts will be resolved through discussion. The methodological quality (or risk of bias) of individual studies will be appraised using an appropriate tool. A narrative synthesis will summarize and explain the characteristics and findings of the studies. If feasible, we will conduct random effects meta-analyses where appropriate., Discussion: This systematic review will analyze the ways in which precarious employment affects migrant workers' mental health and the process that underlies this relationship. The results from the systematic review outlined in this protocol will be of interest to labor and health professionals, policy makers, labor unions, and non-governmental organizations. Our findings may encourage and impel related policy makers to establish human-focused, safe and healthy work environments, and workplace conditions., Systematic Review Registration: PROSPERO, CRD42019132560.

Background and Objectives: There is currently intense multidisciplinary interest and a maturing body of literature regarding laser treatments for traumatic scars, but international treatment guidelines and reimbursement schemes have not yet caught up with current knowledge and practice in many centers. The authors intend to highlight the tremendous potential of laser techniques, offer recommendations for safe and efficacious treatment, and promote wider patient access guided by future high-quality research., Study Design/materials and Methods: An international panel of 26 dermatologists and plastic and reconstructive surgeons from 13 different countries and a variety of practice backgrounds was self-assembled to develop updated consensus recommendations for the laser treatment of traumatic scars. A three-step modified Delphi method took place between March 2018 and March 2019 consisting of two rounds of emailed questionnaires and supplementary face-to-face meetings. The panel members approved the final manuscript via email correspondence, and the threshold for consensus was at least 80% concurrence among the panel members., Results: The manuscript includes extensive detailed discussion regarding a variety of laser platforms commonly used for traumatic scar management such as vascular lasers and ablative and non-ablative fractional lasers, special considerations such as coding and laser treatments in skin of color, and 25 summary consensus recommendations., Conclusions: Lasers are a first-line therapy in the management of traumatic scars and contractures, and patients without access to these treatments may not be receiving the best available care after injury. Updated international treatment guidelines and reimbursement schemes, additional high-quality research, and patient access should reflect this status. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc., (Published 2019. This article is a U.S. Government work and is in the public domain in the USA.)

Background and Objectives: Scar rehabilitation is a complex process that incorporates medical, surgical, and physical therapeutic measures to best restore function and visual normalcy. Lasers have emerged as essential tools in the management of scars, with devices available to address scar size, dyschromia, and contour irregularities. As different lasers treat these different features, multi-laser, same session therapeutic approaches may offer a more comprehensive approach to scar revision. In this study, we aim to demonstrate the effect of a combinatorial, same session treatment with intense pulsed light (IPL) and fractional ablative CO 2 as compared to single laser treatment with fractional ablative CO 2 laser alone or control in the treatment of mature hypertrophic scars., Materials and Methods: This institutional review board-approved, randomized controlled trial, enrolled 23 healthy adults with large (>100 cm 2 ) hypertrophic scars who were randomized to one of three treatment arms: (i) IPL and CO 2 ablative fractional laser (AFL), (ii) CO 2 AFL alone, and (iii) control (no laser treatment). Subjects underwent a total of four treatment sessions at 6-8-week intervals with follow-up visits at 1, 3, and 6 months following the last treatment session. Primary endpoints included blinded scoring of before and after photographs via the Manchester Scar Scale (MSS). Secondary endpoints included the Patient-Observer Scar Assessment Scale (POSAS)., Results: As compared to control and CO 2 AFL laser alone, the combination of CO 2 AFL and IPL demonstrated statistically significant improvement across a greater number of scar domains, as assessed by the MSS. 100% of subjects in both treatment groups showed a statistically significant decrease in the POSAS scale after the series of four treatment sessions. No adverse events were reported., Conclusion: Treatment with combined IPL and CO 2 AFL demonstrated higher average improvements across the majority of assessed scar domains, as compared to both control and CO 2 laser alone. The difference was not statistically significant in overall MSS score as expected due to the role of CO 2 as the main source of improvement. However, only the combination group had statistically significant improvement in both color and texture. These findings support the assertion that a multi-photo-thermolytic approach with combined IPL and CO 2 AFL can have a positive impact on the treatment of hypertrophic scars by using multiple wavelengths to maximize laser-skin interactions in targeting the different chromophores expressed in scar tissue. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc., (© 2019 Wiley Periodicals, Inc.)

Background: Metachromatic Leukodystrophy (MLD) is a rare autosomal-recessive lysosomal storage disorder caused by mutations in the ARSA gene. While interventional trials often use untreated siblings as controls, the genotype-phenotype correlation is only partly understood, and the variability of the clinical course between siblings is unclear with some evidence for a discrepant clinical course in juvenile patients. The aim of this study was to systematically investigate the phenotypic variation in MLD siblings in comparison to the variability in a larger MLD cohort and to case reports published in literature., Results: Detailed clinical information was available from 12 sibling-pairs (3 late-infantile, 9 juvenile) and 61 single patients (29 late-infantile, 32 juvenile). Variability of age at onset was similar between the siblings and randomly chosen pairs of the remaining cohort (no statistically different Euclidean distances). However, in children with juvenile MLD both the type of first symptoms and the dynamic of the disease were less variable between siblings compared to the general cohort. In late-infantile patients, type of first symptoms and dynamic of disease were similarly homogeneous between siblings and the whole MLD cohort. Thirteen published case reports of families with affected siblings with MLD are presented with similar findings., Conclusions: In a systematic analysis of phenotypic variation in families with MLD, siblings with the late-infantile form showed a similar variability as unrelated pairs of children with late-infantile MLD, whereas siblings with juvenile MLD showed a more homogeneous phenotype regarding type of first symptoms and disease evolution in comparison to unrelated children with juvenile MLD, but not regarding their age at onset. These results are highly relevant with respect to the evaluation of treatment effects and for counseling of families with affected siblings.

The use of stem cells in regenerative medicine and specifically facial rejuvenation is thought provoking and controversial. Today there is increased emphasis on tissue engineering and regenerative medicine, which translates into a need for a reliable source of stem cells in addition to biomaterial scaffolds and cytokine growth factors. Adipose tissue is currently recognized as an accessible and abundant source for adult stem cells. Cellular therapies and tissue engineering are still in their infancy, and additional basic science and preclinical studies are needed before cosmetic and reconstructive surgical applications can be routinely undertaken and satisfactory levels of patient safety achieved., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Hypertrophic scarring is a fibroproliferative process that occurs following a third-degree dermal burn injury, producing significant morbidity due to persistent pain, itching, cosmetic disfigurement, and loss of function due to contractures. Ablative fractional lasers have emerged clinically as a fundamental or standard therapeutic modality for hypertrophic burn scars. Yet the examination of their histopathological and biochemical mechanisms of tissue remodeling and comparison among different laser types has been lacking. In addition, deficiency of a relevant animal model limits our ability to gain a better understanding of hypertrophic scar pathophysiology. To evaluate the effect of ablative fractional lasers on hypertrophic third-degree burn scars, we have developed an in vivo Red Duroc porcine model. Third-degree burn wounds were created on the backs of animals, and burn scars were allowed to develop for 70 days before treatment. Scars received treatment with either CO2 or erbium: yttrium aluminum garnet (YAG) ablative fractional lasers. Here, we describe the effect of both lasers on hypertrophic third-degree burn scars in Red Duroc pigs. In this report, we found that Er:YAG has improved outcomes versus fractional CO2. Molecular changes noted in the areas of dermal remodeling indicated that matrix metalloproteinase 2, matrix metalloproteinase 9, and Decorin may play a role in this dermal remodeling and account for the enhanced effect of the Er:YAG laser. We have demonstrated that ablative fractional laser treatment of burn scars can lead to favorable clinical, histological, and molecular changes. This study provides support that hypertrophic third-degree burn scars can be modified by fractional laser treatment.

Objective: The aim of this study was to calculate the validity parameters of the Digene Hybrid Capture 2 (HC2) high-risk human papillomavirus DNA test with and without cytology in the follow-up examinations after laser treatment of the transformation zone or large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia (CIN)., Methods: We performed a standardized follow-up examination in 113 postlaser and 153 post-LLETZ patients in our colposcopy clinic. Routine cytology, HC2 tests, and colposcopically-guided cervical biopsies were performed and sensitivity, specificity, and positive and negative predictive values were calculated using the histological cervical biopsy result as the criterion standard., Results: After a median follow-up time of 25.5 months, the overall posttreatment recurrence/persistence rate of CIN 2 or higher (CIN 2+) was 24% after laser and 12.4% after Post-LLETZ treatment. Hybrid Capture 2 alone had a sensitivity/NPV of 70/88% in post-laser and 70/93% in post-LLETZ patients. Cytology alone had a sensitivity/NPV for CIN 2+ of 48/84% in post-laser and 58/91% in post-LLETZ patients. Combined testing of HC2 with cytology had a sensitivity/NPV of 81/92% in postlaser and 88/95% in post-LLETZ patients., Discussion: In this test of cure study, combined testing of cytology with HC2 resulted in a high sensitivity and NPV. Hybrid Capture 2 and cytology-negative women may safely return to routine recall. Cytology alone is not an adequate follow-up strategy in postlaser patients.