Minimizing Medical Error-Related Adverse Events With Platelet-Rich Plasma: A Protocolized Approach to Safety.

Platelet-rich concentrates (PRCs), derived from a patient's blood, are being used in various fields of medicine, including dermatology, for an increasing number of indications. Although considered a generally safe procedure for dermatologic indications, there have been reports in the last several years linking this treatment to cases of blood-borne infections including HIV and hepatitis.1 Patient safety should always be the primary focus for physicians and other health care professionals, and systems-based protocols should exist within care settings to minimize errors. Herein, we review our protocol to decrease the risk of complications related to transmission of blood-borne infections and other medical errors related to PRCs. J Drugs Dermatol. 2024;23(9)790-791. doi:10.36849/JDD.8166.

Deliberations of the Safety Task Force: Risk factors and treatment of adverse events associated with aesthetic injectables.

BACKGROUND: The growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed. AIMS: The inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods. METHODS: The STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon. RESULTS: The establishment of a global database for tracking filler-related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non-medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field. CONCLUSIONS: The STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.

The utility of artificial intelligence platforms for patient-generated questions in Mohs micrographic surgery: a multi-national, blinded expert panel evaluation.

BACKGROUND: Artificial intelligence (AI) and large language models (LLMs) transform how patients inform themselves. LLMs offer potential as educational tools, but their quality depends upon the information generated. Current literature examining AI as an informational tool in dermatology has been limited in evaluating AI's multifaceted roles and diversity of opinions. Here, we evaluate LLMs as a patient-educational tool for Mohs micrographic surgery (MMS) in and out of the clinic utilizing an international expert panel. METHODS: The most common patient MMS questions were extracted from Google and transposed into two LLMs and Google's search engine. 15 MMS surgeons evaluated the generated responses, examining their appropriateness as a patient-facing informational platform, sufficiency of response in a clinical environment, and accuracy of content generated. Validated scales were employed to assess the comprehensibility of each response. RESULTS: The majority of reviewers deemed all LLM responses appropriate. 75% of responses were rated as mostly accurate or higher. ChatGPT had the highest mean accuracy. The majority of the panel deemed 33% of responses sufficient for clinical practice. The mean comprehensibility scores for all platforms indicated a required 10th-grade reading level. CONCLUSIONS: LLM-generated responses were rated as appropriate patient informational sources and mostly accurate in their content. However, these platforms may not provide sufficient information to function in a clinical environment, and complex comprehensibility may represent a barrier to utilization. As the popularity of these platforms increases, it is important for dermatologists to be aware of these limitations.

A Review of Current Data on Duration of Effect in Glabellar Lines After Treatment With AbobotulinumtoxinA 50 U.

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.

Effects of a Sheer 100% Mineral Sunscreen Moisturizer on Facial Photodamage Across Fitzpatrick Skin Types.

BACKGROUND: All skin tones need to be protected from the damaging effects of solar radiation. Although mineral sunscreens offer protection, they can have a thick, greasy feel and leave a white cast, particularly on darker skin tones. Tints offset white cast and provide visible light protection; however, patients may prefer a sheer option. Therefore, a multifunctional, sheer, 100% mineral sunscreen moisturizer (MSM) with broad-spectrum SPF 50 was developed to have positive aesthetics and deliver anti-aging and skin health benefits to all skin tones.  Methods: An IRB-approved, 12-week, open-label clinical study was conducted to investigate the efficacy and tolerability of the MSM. Thirty-nine (39) females aged 35 to 60 years with moderate-severe overall facial photodamage and representing all Fitzpatrick skin types (FST) were recruited. Participants applied the MSM to the face and neck in the morning and reapplied per US Food and Drug Administration requirements. Efficacy and tolerability grading, photography, ultrasound imaging, corneometer measurements, and questionnaires were completed at baseline and weeks 4, 8, and 12.  Results: Statistically significant progressive improvements were demonstrated from baseline to week 12. At week 12, 23.4% and 26.5% mean improvements in overall photodamage were seen for FST I-III and FST IV-VI, respectively. Favorable tolerability was shown for both the face and neck. Photography corroborated clinical grading, and ultrasound imaging indicated a trend in skin density improvement. The MSM was well-perceived.  Conclusion: The MSM is an efficacious and well-tolerated product for patients of all skin tones who desire a sheer, 100% mineral sunscreen moisturizer with anti-aging and skin health benefits. J Drugs Dermatol. 2024;23(7):538-544.  doi:10.36849/JDD.8082.

COVID-19 Admission Rates and Changes in Care Quality in US Hospitals.

Importance: Unprecedented increases in hospital occupancy rates during COVID-19 surges in 2020 caused concern over hospital care quality for patients without COVID-19. Objective: To examine changes in hospital nonsurgical care quality for patients without COVID-19 during periods of high and low COVID-19 admissions. Design, Setting, and Participants: This cross-sectional study used data from the 2019 and 2020 Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project State Inpatient Databases. Data were obtained for all nonfederal, acute care hospitals in 36 states with admissions in 2019 and 2020, and patients without a diagnosis of COVID-19 or pneumonia who were at risk for selected quality indicators were included. The data analysis was performed between January 1, 2023, and March 15, 2024. Exposure: Each hospital and week in 2020 was categorized based on the number of COVID-19 admissions per 100 beds: less than 1.0, 1.0 to 4.9, 5.0 to 9.9, 10.0 to 14.9, and 15.0 or greater. Main Outcomes and Measures: The main outcomes were rates of adverse outcomes for selected quality indicators, including pressure ulcers and in-hospital mortality for acute myocardial infarction, heart failure, acute stroke, gastrointestinal hemorrhage, hip fracture, and percutaneous coronary intervention. Changes in 2020 compared with 2019 were calculated for each level of the weekly COVID-19 admission rate, adjusting for case-mix and hospital-month fixed effects. Changes during weeks with high COVID-19 admissions (≥15 per 100 beds) were compared with changes during weeks with low COVID-19 admissions (<1 per 100 beds). Results: The analysis included 19 111 629 discharges (50.3% female; mean [SD] age, 63.0 [18.0] years) from 3283 hospitals in 36 states. In weeks 18 to 48 of 2020, 35 851 hospital-weeks (36.7%) had low COVID-19 admission rates, and 8094 (8.3%) had high rates. Quality indicators for patients without COVID-19 significantly worsened in 2020 during weeks with high vs low COVID-19 admissions. Pressure ulcer rates increased by 0.09 per 1000 admissions (95% CI, 0.01-0.17 per 1000 admissions; relative change, 24.3%), heart failure mortality increased by 0.40 per 100 admissions (95% CI, 0.18-0.63 per 100 admissions; relative change, 21.1%), hip fracture mortality increased by 0.40 per 100 admissions (95% CI, 0.04-0.77 per 100 admissions; relative change, 29.4%), and a weighted mean of mortality for the selected indicators increased by 0.30 per 100 admissions (95% CI, 0.14-0.45 per 100 admissions; relative change, 10.6%). Conclusions and Relevance: In this cross-sectional study, COVID-19 surges were associated with declines in hospital quality, highlighting the importance of identifying and implementing strategies to maintain care quality during periods of high hospital use.

Ultraviolet Protection From a Patented Amino Acid Complex Technology.

OBJECTIVE:   This study aimed to investigate the ultraviolet (UV) protection/repair benefits of a patented Amino Acid Complex (AAComplex). METHODS: I) AAComplex was incubated with dermal fibroblasts, with/without UVA, and collagen I was measured with a GlasBoxPlus device. II) A lotion, with/without AAComplex (1%) was applied topically to skin explants, following UVA irradiation, and quantified for health-related biomarkers (TNFalpha, histamine, and MMP-1). III) A broad spectrum sunscreen with SPF 46 and a skincare serum containing AAComplex (2%) were assessed using epidermal equivalents, in the presence of UV irradiation, for effects on IL-1alpha, thymine dimers, Ki-67, filaggrin and Nrf2. RESULTS: I) Collagen I synthesis in dermal fibroblasts was significantly decreased after UVA compared to without UV. The presence of AAComplex prevented this decrease. II) UVA irradiation of skin explants increased histamine, TNFα, and MMP-1. Hydrocortisone aceponate cream significantly decreases all 3 biomarkers. AAComplex contained lotion also significantly decreased all 3 biomarkers, the no AAComplex control lotion only reduced histamine. III) With the regimen of sunscreen + AAComplex contained skincare serum, the significant reduction in IL-1alpha was observed along with a complete recovery of Ki-67 and stimulation of filaggrin and Nrf2T. No thymine dimer positive cell was observed indicating the most positive skin impact from the regiment.  Conclusion: This research using different human skin models demonstrated that AAComplex can provide protection and damage repair caused by UV, at the ingredient level also when formulated in a serum or lotion formula. Skin may be best protected from UV damage when the regimen is used.   J Drugs Dermatol. 2024;23(5):366-375. doi:10.36849/JDD.7916.

Spontaneous resolution of eruptive papules following ablative laser resurfacing-Case report and review of laser-associated eruptive keratoacanthomas.

BACKGROUND: Keratoacanthomas (KAs) following laser treatment are a rare, but well-described entity. AIM: Herein, we describe a case of eruptive keratoacanthoma (KA) following laser resurfacing treatment and aim to better characterize laser-associated KAs. METHODS: A literature search was performed on PubMed reviewing laser-associated KAs including various characteristics: epidemiology, history of skin cancer, location, and number, type of laser, as well as the management and outcome. RESULTS: Fractional ablative was the most common type of laser triggering KAs, and most cases presented within the first month following treatment. The majority of cases of laser-induced KA had a prior history of a malignant or premalignant skin neoplasm. Laser-induced KAs were treated using modalities similar to KAs arising in other contexts. CONCLUSION: Clinicians need to be knowledgeable and prepared to understand, and manage complications following laser treatments, as rare as they may be, including KAs.

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.

BACKGROUND: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS: Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001). CONCLUSION: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.

A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

Non-pyrogenicity and biocompatibility of parylene-coated magnetic bead implants.

Clinical grade magnetic bead implants have important applications in interfacing with the human body, providing contactless mechanical attachment or wireless communication through human tissue. We recently developed a new strategy, magnetomicrometry, that uses magnetic bead implants as passive communication devices to wirelessly sense muscle tissue lengths. We manufactured clinical-grade magnetic bead implants and verified their biocompatibility via intramuscular implantation, cytotoxicity, sensitization, and intracutaneous irritation testing. In this work, we test the pyrogenicity of the magnetic bead implants via a lagomorph model, and we test the biocompatibility of the magnetic bead implants via a full chemical characterization and toxicological risk assessment. Further, we test the cleaning, sterilization, and dry time of the devices that are used to deploy these magnetic bead implants. We find that the magnetic bead implants are non-pyrogenic and biocompatible, with the insertion device determined to be safe to clean, sterilize, and dry in a healthcare setting. These results provide confidence for the safe use of these magnetic bead implants in humans.

Quantifying how much host, pathogen, and other factors affect human protective adaptive immune responses.

Recognizing the "essential" factors that contribute to a clinical outcome is critical for designing appropriate therapies and prioritizing limited medical resources. Demonstrating a high correlation between a factor and an outcome does not necessarily imply an essential role of the factor to the outcome. Human protective adaptive immune responses to pathogens vary among (and perhaps within) pathogenic strains, human individual hosts, and in response to other factors. Which of these has an "essential" role? We offer three statistical approaches that predict the presence of newly contributing factor(s) and then quantify the influence of host, pathogen, and the new factors on immune responses. We illustrate these approaches using previous data from the protective adaptive immune response (cellular and humoral) by human hosts to various strains of the same pathogenic bacterial species. Taylor's law predicts the existence of other factors potentially contributing to the human protective adaptive immune response in addition to inter-individual host and intra-bacterial species inter-strain variability. A mixed linear model measures the relative contribution of the known variables, individual human hosts and bacterial strains, and estimates the summed contributions of the newly predicted but unknown factors to the combined adaptive immune response. A principal component analysis predicts the presence of sub-variables (currently not defined) within bacterial strains and individuals that may contribute to the combined immune response. These observations have statistical, biological, clinical, and therapeutic implications.

The role of laser and energy-assisted drug delivery in the treatment of alopecia.

It has been recently established that laser treatment can be combined with topical or intralesional medications to enhance the delivery of drugs and improve overall results in a variety of different dermatological disorders. The aim of this review is to evaluate the use of laser and energy-assisted drug delivery (LEADD) for the treatment of alopecia with a specific focus on ablative fractional lasers (AFL), non-ablative fractional lasers (NAFL), and radiofrequency microneedling (RFMN). A comprehensive PubMed search was performed in December 2022 for "laser-assisted drug delivery" as well as "laser" and "alopecia." The evidence regarding LEADD for alopecia treatment is limited to two specific alopecia subtypes: alopecia areata (AA) and androgenetic alopecia (AGA)/pattern hair loss (PHL). LEADD with minoxidil and platelet-rich plasma (PRP) were evaluated for efficacy in both treatments of AA and AGA. LEADD with topical corticosteroids and intralesional methotrexate were studied for the treatment of AA, while LEADD with growth factors and stem cells were studied for the treatment of AGA. Multiple RCTs evaluated LEADD for topical corticosteroids with ablative fractional lasers for the treatment of AA. There is evidence in the literature that supports the use of topical minoxidil in combination with all devices for the treatment of AGA/PHL. All the reviewed studies show a positive treatment effect with LADD; however, some trials did not find LEADD to be superior to monotherapy or microneedling-assisted drug delivery. LEADD is a rapidly emerging treatment modality for the treatment of AGA and AA.

A focused review on laser- and energy-assisted drug delivery for nail disorders.

The purpose of this review is to consolidate and summarize laser-assisted drug delivery (LADD) for nail diseases, particularly onychomycosis and psoriasis. A PubMed search was conducted in June 2023 using search terms (1) "laser assisted drug delivery" AND "nail," (2) "laser" AND "nail," and (3) "nail disorder" AND "laser treatment." References of papers were also reviewed, yielding 15 papers for this review. Fractional ablative CO2 laser (FACL) and Er:YAG laser can be used for LADD of topical medications such as amorolfine, terbinafine, and tioconazole to treat onychomycosis. A fungal culture should be performed to determine the type of dermatophyte, which will help determine which topical will be most effective. Laser settings varied between studies, but overall LADD tended to be more effective than topical treatments alone. Laser-assisted photodynamic therapy (PDT) was also found to be effective in treating onychomycosis. For psoriatic nails, LADD was used to deliver calcipotriol-betamethasone dipropionate foam, tazarotene, triamcinolone, or methotrexate into the nail. Again, LADD was found to be significantly more effective than topical treatment alone. FACL was the only laser noted for use for LADD in both diseases. Laser-assisted drug delivery for nail disease is a newer approach for onychomycosis and nail psoriasis with several benefits and drawbacks. Dermatologists should discuss the option of LADD with their patients who have recalcitrant onychomycosis or nail psoriasis.