Rapidly Growing and Aggressive Squamous Cell Carcinoma of the Forearm: A Report of Successful Treatment With Mohs Surgery and Complex Reconstruction With Rhombic Triple Z-Plasty.

Reconstruction of complex post-surgical wounds requires functional and aesthetic considerations. We present a case of a complex radial-dorsal forearm defect in a patient who underwent Mohs surgery for an aggressive and rapidly growing squamous cell carcinoma. Following complete tumor excision, we utilized a modified rhombic flap for complete wound coverage with long-term conservation of extensor function. The rhombic flap modification included three Z-plasties at the flap base to add rotational components to the flap transposition. Long-term follow-up showed acceptable cosmesis, preserved extensor tendon function, and no evidence of tumor recurrence.

YouTube as a Source of Hidradenitis Suppurativa Patient Education: A Social Media Content Analysis.

Hidradenitis suppurativa (HS) is a chronic and painful skin condition that is difficult to treat. Patients commonly navigate YouTube's platform for insight into different treatment options; thus, we analyzed the content and quality of the top 100 HS videos to assess which treatment options were most favored. Our study indicated a growing number of informational videos on the platform over 10 years, with the majority of the content from the United States. Surgical videos had higher view counts than nonsurgical ones, even though the level of engagement measured by likes and comments was similar between the two. There were no differences in the presented tone between the two categories. Overall, YouTube videos have a moderate quality with no serious shortcomings based on a previously validated DISCERN instrument score. Healthcare professionals treating HS patients should continue to direct patients to evidenced-based sources of reliable information on their condition.

Evaluating publication bias for clinical trials supporting new dermatologic drug approvals from 2003 to 2018.

The degree of publication bias and impact of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which aimed to improve clinical trial transparency, has yet to be examined for recent dermatologic drugs. The objective of our study was to estimate the degree of publication bias for clinical trials supporting FDA approval of new dermatologic drugs. This retrospective cohort study examined all phase II and III efficacy trials supporting approval of new dermatologic drugs from 2003 to 2018. FDA drug approval documents were reviewed for supportive clinical trial information, and publications were matched using PubMed and Google Scholar searches. Ratios of relative risks (RRR) comparing positive versus non-positive trials before and after FDAAA enactment served to estimate publication bias. We found that the likelihood of publishing positive versus non-positive drug trials in dermatology was unchanged before and after FDAAA enactment (RRR 0.87, 95% CI 0.37-2.08), as was the likelihood of publishing without misleading interpretation (RRR 1.51, 95% CI 0.22-10.50). There was no measurable publication bias for efficacy trials supporting new drug approvals in dermatology over the past 15 years. Fewer pre-FDAAA trials (n = 21) compared to post-FDAAA trials (n = 106) met inclusion criteria. Though not analyzed in this study, safety and secondary efficacy results are other potential sources for publication bias.

The Treatment of a Multisubunit Defect of the Earlobe Involving an Exposed Parotid Gland.

Defects with multiple aesthetic subunits may need specific approaches for each subunit. We present a case of a post-surgical defect in a patient who underwent Mohs micrographic surgery for an invasive melanoma of the earlobe with an exposed parotid gland. We utilized a retroauricular-based rhomboid flap to provide full and immediate coverage for earlobe reconstruction in the setting of insufficient infra-auricular recruitable skin. The addition of Z-plasties at the base of an interpolation flap may reduce rotational restraint, thereby improving perfusion while enhancing flap extension for complete wound coverage where there is a lack of abundant donor tissue. The patient healed appropriately with no evidence of tumor recurrence.

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.

Trends in emergency department visits due to sunburn and factors associated with severe sunburns in the United States.

Little is known regarding the burden of sunburns leading to emergency department (ED) visits in the United States (US). The objectives of this research were to characterize the burden of sunburn ED visits, investigate predictors of severe sunburns, and evaluate risk factors for increased cost of care in patients presenting to the ED for sunburn. In this nationally representative cross-sectional study of the National Emergency Department Sample (NEDS, 2013-2015), multivariable models were created to evaluate adjusted odds for sunburn ED visits, seasonal/regional variation in sunburn ED visits, adjusted odds for second and third degree sunburns, and risk factors for increased ED expenditure. 82,048 sunburn ED visits were included in this study. On average, the cost of care for a sunburn ED visit was $1132.25 (± $28.69). The prevalence and cost of ED visits due to sunburn increased during the summer months. Controlling for sociodemographic factors, comorbidities, and hospital characteristics, patients presenting to the ED for all sunburns (and for severe sunburns) were most likely to be lower income young adult men. Older, higher income patients in metropolitan hospitals had more expensive ED visits. This research provides nationally representative estimates of visits to the ED due to sunburn in the US, as well as evaluates determinants for severe sunburns and more expensive sunburn ED visits. Ultimately, characterizing the national burden of ED visits due to sunburn is critical in the development of interventions to reduce the impact of sunburn ED visits on the US healthcare system.

Impact of congenital cutaneous hemangiomas on newborn care in the United States.

Little is known regarding the characteristics of newborns with congenital cutaneous hemangioma (CH) and the burden of CH on newborn care. The objective of this study is to describe the burden of CH on newborn inpatient stays in the United States. Specific aims include characterizing newborns with CH, assessing factors predictive of CH and procedures performed during hospitalization, determining characteristics associated with increased cost of care and length of stay in newborns with CH, and investigating trends in prevalence, length of stay, and cost of care. This is a nationally representative retrospective cohort study (National Inpatient Sample, 2009-2015). Sociodemographic factors associated with CH and risk factors for increased cost of care/length of stay were evaluated using weighted multivariable regression models. Overall prevalence of CH is 17.0 per 10,000 newborns. Cost of care and length of stay for newborns with CH are increasing over time. Controlling for all covariates, white (aOR 1.69), female (aOR 1.52) newborns from higher income families (aOR 1.44) were more likely to be born with CH (p < 0.001). Newborns with CH who were premature (aOR 3.88), underwent more procedures (aOR 8.81), and born in urban teaching hospitals (aOR 2.66) had the greatest cost of care (p < 0.001). Premature (aOR 3.74) newborns with CH in urban teaching hospitals (aOR 1.31) had the longest hospital stays (p < 0.001). The burden of CH in newborns is substantial and increasing over time. Understanding contributors to costly hospital stays is critical in developing evidence-based guidelines to reduce the growing impact of CH on newborn care.

Ultraviolet Light Gel Manicures: Is There a Risk of Skin Cancer on the Hands and Nails of Young Adults?

BACKGROUND: There appears to be limited research on whether the ultraviolet radiation used in nail lamps for gel manicures is increasing the incidence of skin cancer on the hands and nails of young adults. OBJECTIVE: We sought to assess evidence in the literature regarding the incidence of skin cancer on the hands and nails of young adults who receive gel manicures cured by ultraviolet light. METHODS: An extensive systematic literature review was conducted, focusing on patients aged 40 years or younger with a history of gel manicures diagnosed with nonmelanoma or melanoma skin cancers on the dorsum of their hands and nails. The Surveillance, Epidemiology and End-results Program (SEER) (SEER 9 and SEER 21) was chosen to analyze trends in the incidence of melanoma from 2007 to 2016. The SEER*Stat Client-serve Mode software was used to retrieve the incidence rates of melanoma of the skin among individuals aged 0 to 39 years from 1975 to 2016. RESULTS: There have been no cases reported of patients younger than the age of 40 years with a history of chronic gel manicures diagnosed with nonmelanoma skin cancer or melanoma on the dorsum of the hands or nail matrices. SEER revealed little to no change in the incidence of melanoma among patients under the age of 65 years. CONCLUSION: The literature is controversial regarding whether ultraviolet radiation from chronic gel manicures increases the risk of skin cancer on the hands and nails. A comprehensive literature search and the SEER database revealed that gel manicures have little to no carcinogenic risk.

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.

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.

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.

Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.

Introduction: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators.Methods: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage.Results: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers.Discussion: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.