Pure and Mixed Desmoplastic Melanomas: A Retrospective Clinicopathologic Comparison of 33 Cases.

BACKGROUND: Pure and mixed desmoplastic melanomas (DMs) may have different natural histories and behaviors. METHODS: We conducted a retrospective review of patients diagnosed with DM at our institution between January 1997 and April 2019. A total of 33 unique DMs were identified and subsequently analyzed based on the histologic type (pure vs. mixed). RESULTS: The majority (57.6%) of our cases were classified as pure histology. Patients with pure DMs were more likely to be men (P = 0.035) and be older than 65 years (P = 0.019) compared with patients with mixed DMs. Patients with mixed DM were more likely to have mitoses present (P = 0.001) compared with patients with pure DM. There were no differences in ulceration, perineural invasion, vascular invasion, or survival between patients with pure and mixed histologic subtypes. In addition, no differences in sentinel lymph node biopsy, radiation, or chemotherapy were noted between the 2 histologic subtypes. Immunohistochemistry showed that 27.3% of the pure DMs stained with Melan-A and HMB45 were positive for these immunomarkers. CONCLUSIONS: Pure and mixed variants of DM were found to have similar clinicopathologic characteristics. Patients with the mixed histologic subtype were more likely to have mitoses, but no difference in the therapeutic management or patient survival was seen between the 2 subtypes.

Emergency Department Visits due to Scabies in the United States: A Retrospective Analysis of a Nationally Representative Emergency Department Sample.

BACKGROUND: Limited information exists regarding the burden of emergency department (ED) visits due to scabies in the United States. The goal of this study was to provide population-level estimates regarding scabies visits to American EDs. METHODS: This study was a retrospective analysis of the nationally representative National Emergency Department Sample from 2013 to 2015. Outcomes included adjusted odds for scabies ED visits, adjusted odds for inpatient admission due to scabies in the ED scabies population, predictors for cost of care, and seasonal/regional variation in cost and prevalence of scabies ED visits. RESULTS: Our patient population included 416 017 218 ED visits from 2013 to 2015, of which 356 267 were due to scabies (prevalence = 85.7 per 100 000 ED visits). The average annual expenditure for scabies ED visits was $67 125 780.36. The average cost of care for a scabies ED visit was $750.91 (±17.41). Patients visiting the ED for scabies were most likely to be male children from lower income quartiles and were most likely to present to the ED on weekdays in the fall, controlling for all other factors. Scabies ED patients that were male, older, insured by Medicare, from the highest income quartile, and from the Midwest/West were most likely to be admitted as inpatients. Older, higher income, Medicare patients in large Northeastern metropolitan cities had the greatest cost of care. CONCLUSION: This study provides comprehensive nationally representative estimates of the burden of scabies ED visits on the American healthcare system. These findings are important for developing targeted interventions to decrease the incidence and burden of scabies in American EDs.

Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.

BACKGROUND AND OBJECTIVES: Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway. STUDY DESIGN/MATERIALS AND METHODS: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories. RESULTS: Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices. CONCLUSIONS: Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

Characteristics of Patients Hospitalized for Cutaneous Squamous Cell Carcinoma.

BACKGROUND: Knowledge regarding the inpatient burden of cutaneous squamous cell carcinoma (cSCC) is limited. OBJECTIVE: To provide nationally representative estimates for hospitalization characteristics due to cSCC and determine predictors for increased length of stay (LOS) and cost of care. METHODS/MATERIALS: A retrospective cohort study of the 2009 to 2015 National Inpatient Sample. Weighted multivariate logistic/linear regression models were created to evaluate sociodemographic factors associated with cSCC hospitalization and to assess characteristics associated with cost of care and LOS. RESULTS: This study included 15,784 cSCC and 255,244,626 non-SCC inpatients (prevalence = 6.2/100,000 inpatients). On average, cSCC hospitalizations lasted 5.8 days and cost $66,841.00. Cutaneous squamous cell carcinoma most often occurred on the scalp (30.57%), face (21.08%), and lower limb (11.93%). Controlling for all other factors, cSCC inpatients presented to larger/urban/teaching hospitals and were most often older non-Hispanic white women. More chronic conditions/diagnoses/procedures and nonwhite race were associated with greater cost of care and LOS. Cost of care and LOS significantly differed between cSCCs of different anatomical sites. The most common procedures performed were skin grafts (27.96%), excisions (25.83%), and lymph node biopsies (11.39%). CONCLUSION: This study highlights the substantial burden of inpatient cSCC in the United States. Further research is necessary to prevent cSCC hospitalizations and improve inpatient dermatologic care for cSCC.

Safety and Efficacy of Mohs Micrographic Surgery in Children and Adolescents: A Systematic Review.

BACKGROUND: Although there is a large body of evidence demonstrating the safety and efficacy of Mohs micrographic surgery (MMS) in adults, little is known regarding the safety and efficacy of MMS in children and adolescents. METHODS: The authors searched all publications from 1993 to 2018 reporting on the use of MMS for the treatment of cutaneous neoplasms in patients aged 0 to 18 years. Patient demographics, surgical characteristics, outcomes, and complications were extracted from each report. RESULTS: Forty-one publications describing 58 patients were included in the final analysis. The mean age was 8.3 years, and the most commonly treated tumor was dermatofibrosarcoma protuberans. There were no recurrences noted at a mean follow-up of 2 years. Two (3.4%) patients experienced complications after MMS. CONCLUSION: In this systematic review, the authors present aggregate data demonstrating high safety and efficacy of MMS in children and adolescents. Further research is necessary to develop guidelines for the use of MMS in children and adolescents.

United States Stock Market Response to FDA Approval of New Dermatologic Drugs

BACKGROUND: The Food and Drug Administration (FDA) has approved several new dermatologic drugs in the last decade. The public response to their approval has not yet been evaluated. OBJECTIVE: To analyze the United States stock market response surrounding FDA approval of new dermatologic drugs between 2008 and 2018. METHODS: A list of 34 FDA approved dermatologic drugs for publicly traded companies was compiled from the CenterWatch New Dermatology Drugs List and the FDA Annual Reports on New Drugs. Company and stock market data was acquired from the Center for Research in Security Prices (CRSP) United States Stock database. Cumulative abnormal returns (CAR) were calculated as the difference between raw returns and expected value-weighted returns. Data analyses were performed using SAS 9.4 (Cary, NC). RESULTS: The average CAR for the 21-day window period surrounding FDA approval of new dermatologic drugs was +1.71%. Drugs approved for the treatment of hyperhidrosis (+17.7%), bacterial skin infections (+7.18%), and rosacea (+6.83%) added the most market value. LIMITATIONS: The market value added to private or internationally traded companies could not be assessed. CONCLUSION: FDA approval of dermatologic drugs generally has a positive market response. Information on market reaction may provide important insights for investors, pharmaceutical companies, and researchers. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5033.

Erosive pustular dermatosis of the scalp following surgical procedures: a systematic review.

Erosive pustular dermatosis of the scalp (EPDS) occurs in elderly individuals with significant actinic damage. EPDS also occurs in association with surgery; however, significant studies determining an association of EPDS with type of surgical closure is absent. This review examines whether the closure method following cutaneous surgery performed on the scalp is associated with development of EPDS. Databases were reviewed and studies describing EPDS after cutaneous surgery met inclusion criteria. Articles were excluded if EPDS developed after trauma or non-surgical procedures. Descriptive analyses were performed on the data. Thirteen case reports and 6 case series involving 32 patients met inclusion criteria. Fourteen articles (73.7%) stated that EPDS developed in the same location as, or near to, the closure site. Thirteen patients (40.6%) developed EPDS following skin grafting. Three patients (9.4%) developed EPDS following secondary intention healing, two patients (6.3%) following repair by primary intention, and one patient (3.1%) following repair with a local skin flap. Thirteen cases (40.6%) did not specify closure type. This review revealed that surgical procedures performed on the scalp utilizing skin grafts for closure may be increasingly associated with the development of EPDS compared to other closure types.

Low-dose naltrexone: a unique treatment for amyopathic dermatomyositis.

Gottron papules, a heliotrope rash, scalp and extremity erythema, pruritus, and fatigue are the characteristic signs and symptoms of amyopathic dermatomyositis (ADM). Amyopathic dermatomyositis is considered a distinct entity from dermatomyositis (DM) because the characteristic muscle weakness and muscle enzyme elevations of DM are absent in ADM. With respects to treatment, ADM treatments have traditionally included topical corticosteroids and/or systemic immunosuppressants and immunomodulators. Herein we present a patient with refractory ADM that was responsive to low-dose naltrexone therapy.

Over-the-counter light therapy for acne: a cross-sectional retrospective analysis.

Acne vulgaris affects a large portion of the population and drives many patients to seek over-the-counter (OTC) treatments. Light-emitting diode (LED) therapy has recently emerged as a potential therapeutic option for inflammatory acne. We used the U.S. Food and Drug Administration (FDA) 510(k) premarket submission database to assess the growth in OTC LED therapy devices for treatment of acne. We also used Google Trends data in searches for "acne light therapy mask" to characterize growth in consumer interest in these devices. Overall, 35 LED devices received pre-market approval from 2000 to 2018, with a peak in approvals in 2016. Similarly, there was a dramatic increase in public interest in these devices in 2016. Only two devices were associated with company-approved trials. The current regulatory process requires little evidence to substantiate specified uses and a better understanding of practice guidelines and the efficacy of this treatment modality is required.

Prescribing trends for biologic drugs among Ohio dermatologists.

The role of biologic therapies in the field of dermatology continues to evolve as newer drugs and biosimilars are introduced to the U.S. market. Prescribing patterns and expenditures regarding biologic drugs are not well described. To address this knowledge gap, a retrospective review was conducted using the Medicare Provider Utilization and Payment Data: Part D Prescriber dataset between January 1st, 2013 and December 31st, 2015. The primary outcome was claims per provider per calendar year. Secondary outcomes included drug cost, shared cost per dermatologist, and practice location. Median claims per provider remained stable between 2013 and 2014 (24 versus 23, respectively; P=0.64). The majority of 2015 claims were for adalimumab (50.1%) and etanercept (41.4%). Total spending from Medicare payment data for biologic drugs prescribed by Ohio dermatologists increased by $3 million during the study period. The Gini coefficient for provider contributions to overall costs was 0.47, indicating moderate inequality among Ohio dermatologists. Spending associated with biologic drugs used for dermatologic indications is increasing in Ohio. As the market changes, providers should be aware of these patterns to better care for patients in need of biologic therapies.