Dermatology

The evaluation of pediatric patients with subcutaneous nodules remains a diagnostic challenge. Pediatric dermatologists are regularly confronted with patients who have a nonspecific nodule. Though most masses that require evaluation are ultimately benign, the possibility of a more aggressive process, including borderline or malignant neoplasms, underscores the pivotal role of the pediatric dermatologist in recognizing these lesions. The aim of this review is to provide an overview of lumps and bumps that are important to recognize to prevent delay in diagnosis or treatment of a serious underlying condition...

Acne vulgaris is among the most common skin disorders afflicting adolescents worldwide, and though well-established guidelines of care exist for acne management, these guidelines do not uniformly consider or address the unique psychosocial and medical needs of transgender and gender diverse (TGD) youth. Part 2 of this two-part review provides guidance on a stepwise approach to the medical treatment of acne in TGD youth, with an emphasis on safety, efficacy, and the delivery of medical care in a culturally humble, thoughtful, and gender-affirming manner...

Acne vulgaris is among the most common skin disorders afflicting adolescents worldwide, and though well-established guidelines of care exist for acne management, these guidelines do not uniformly consider or address the unique psychosocial and medical needs of transgender and gender diverse (TGD) youth. TGD youth may possess distinct goals of therapy when treating their acne; the use of medicines routinely employed to treat acne may also expose TGD adolescents receiving gender affirming medical therapy to greater risk of adverse events...

An increasing body of literature describes underreporting of race and ethnicity, and overrepresentation of White individuals in clinical trials. We aimed to evaluate the racial and ethnic diversity of US participants in clinical trials for acne, atopic dermatitis (AD), and psoriasis. We performed a comprehensive review of clinical trials for these common dermatologic diseases that were published between January 2014 and July 2019. Race and ethnicity reporting among all trials, and the racial and ethnic distribution of US participants were compared by skin disease, intervention type, and trial phase...

Lichen planus (LP) is an auto-inflammatory skin disorder identified by a presence of T-cell lymphocytes at the dermal-epidermal junction. It is hypothesized that the INF-γ/CXCL10 axis fulfills a major role in the onset and persistence of chronic inflammation in LP. Since Janus kinases (JAKs) are involved in the transduction of INF-γ signals, they may be good targets for LP treatment. Several case reports and case series described the safety and efficacy of upadacitinib (2 articles), tofacitinib (6 articles), baricitinib (4 articles), and Ruxolitinib (1 Article) in the treatment of LP variants...

BACKGROUND: Programmed cell death-1 (PD-1) inhibitors represent an effective treatment option for advanced cutaneous squamous cell carcinoma (cSCC). However, solid organ transplant (SOT) recipients with cSCC have traditionally been excluded from clinical trials. OBJECTIVE: To assess the safety and efficacy of PD-1 inhibitors for stage III-IV cSCC in SOT recipients. MATERIALS & METHODS: A systematic review was performed using the PubMed, EMBASE, and Scopus databases...

The widespread use of skin sensitizing preservatives is well-known. Contact allergy to preservatives is often caused by their presence in cosmetic products. Preservative use in non-cosmetic products is less well-known. We have reviewed European Union (EU) legislations on classification and labelling, biocides and cosmetics, concerning conditions for use of the most used sensitizing preservatives (including formaldehyde-releasing substances, isothiazolinones and parabens). We have analysed temporal trends in their use in non-cosmetic products (tonnes, number of products, concentrations), based on annual reports to the Swedish Products Register 1995-2018; and we discuss implications for stakeholders...

The use of masks for infection control was common in the COVID-19 pandemic. As numerous cross-sectional studies have suggested a link between the use of such masks and various facial dermatoses, a systematic review and meta-analysis of published studies was conducted to evaluate this association, as well as potential risk factors for the development of such facial dermatoses. Observational studies were searched for in MEDLINE, EMBASE and the Cochrane Central Register. Thirty-seven observational studies with a total of 29 557 study participants were identified...

In the United States, the Food and Drug Administration's (FDA's) regulatory authorities have significantly influenced the products available to treat dermatologic conditions, but at the same time, advances in dermatology have also influenced the FDA's approach, including the agency's evaluation of risks and its' communications to consumers, patients, and providers. This essay reviews significant milestones in the history of FDA's regulation of dermatologic products, with attention paid to significant products, impactful legal changes, and key personnel and organizational changes...

The mission of the Food and Drug Administration (FDA) is to ensure the safety and effectiveness of dermatologic drugs, as authorized by the Federal Food, Drug, and Cosmetic Act (FD&CA). In this article, we discuss how the FDA's policies and practices have continued to evolve to incorporate scientific advances and to facilitate approval for dermatologic drugs in a timely manner for a broad spectrum of patients. We provide several examples to highlight areas where the Division of Dermatology and Dentistry found common ground with stakeholders to increase the therapeutic options for dermatologic patients, while still maintaining regulatory standards required for approval...

Postmarket surveillance is critical for the identification of rare safety risks, which are unlikely to be identified during clinical trials and the drug development program. Rare adverse drug reactions with the potential for serious outcomes, including fatalities, include the severe cutaneous adverse reactions of Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. Dermatologists play an important role in the diagnosis of these serious drug reactions and contribute to drug safety by reporting cases of suspected cutaneous adverse drug reactions...

Approved generic drugs are therapeutically equivalent to a preidentified brand name product and are expected to have the same clinical effect and safety profile when administered to patients under conditions specified in the labeling. Availability of generic topical dermatologic drugs is expected to enhance patient access to such widely used drug products. Assessment of equivalence for a prospective generic product involves a systematic and rigorous comparative evaluation to ensure there is no significant difference in the rate and extent to which the active ingredients become available at the site of action for the prospective generic and corresponding brand name product...

Drug development regulation needs of the pediatric population were not addressed until later in the twentieth century. Because of legislation including the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), clinical trials and data analysis targeting the pediatric population have resulted in drug product labeling. Drug products with pediatric dermatology indications benefit from BPCA, PREA, exclusivity incentives, newer analytical methods, and Food and Drug Administration team review...

Medical devices became subject to the current framework of regulation and premarket review by the Food and Drug Administration (FDA) in 1976. Devices are distinguished from drugs by the means in which they achieve their primary intended purposes. All medical devices, regardless of risk, share certain regulatory requirements to assure quality, safety, and transparency. Moderate- to high-risk devices must additionally be cleared or approved by FDA before being introduced into interstate commerce. Dermatologic devices regulated by FDA range from high-power energy-based devices to wound dressings, and from complex electronic devices to topically applied barrier creams...

In the United States, cosmetics are regulated under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Accordingly, cosmetic ingredients, with the exception of color additives, are not subject to premarket approval. However, they must not be adulterated or misbranded. This article describes the statutes and regulations relevant to cosmetic regulation by the Food and Drug Administration (FDA). It also describes relevant domestic programs of the FDA (Voluntary Cosmetic Registration Program, Good Manufacturing Practice guidance, Adverse Event Reporting System, Recalls) and international efforts regarding cosmetics regulation...

The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. Pharmacokinetics-based approaches characterize the rate and extent to which an active ingredient becomes available at or near its site of action in the skin. Such methodologies are considered to be among the most accurate, sensitive, and reproducible approaches for determining the BA or BE of a product...

Incorporating the patient voice into drug development and regulatory review process allows for the science of drug development to be more patient-centered. Dermatology is one therapeutic area where patients have the potential to provide valuable perspectives on symptoms, functional impacts, and aesthetic outcomes. Patient-reported and observer-reported outcomes play an important role in capturing concerns related to the disease or condition and its treatment. Patient experience data from well-designed trials are critical for regulatory decision-making and ultimately enable prescribers and patients to make better informed treatment decisions at the point of care...

BACKGROUND: Acute Generalized Exanthematous Pustulosis (AGEP) is a rash with multiple sterile intraepidermal or sub corneal non-follicular pustules on edematous papules, with a sudden development and rapid evolution, triggered by drugs, vaccination, insect bites, exposure to mercury and allergens. OBJECTIVES AND METHODS: We describe a female patient who developed extensive and abnormally prolonged AGEP following exposure to terbinafine and Sars-COV Vaccine. A detailed review of terbinafine-induced-AGEP cases was performed, with the aim of evaluating if the AGEP criteria would follow a different pattern when the disease is triggered by this drug...

At present, there is still a lack of effective invasive fungal prophylaxis therapy in liver transplant recipients (LTRs). This study aimed to analysis the latest evidence on efficacy of current prophylactic anti-fungal therapy, and systematically compare between anti-fungal agents and placebo by a fixed-effects meta-analysis in all randomised controlled trials. A network meta-analysis was performed for invasive fungal infection (IFI) among different agents in 14 randomised controlled trials, in which 10 anti-fungal approaches were identified...

BACKGROUND: The Fungal Infections Definitions in Intensive Care Unit (ICU) patients (FUNDICU) project aims to provide standard sets of definitions for invasive fungal diseases in critically ill, adult patients. OBJECTIVES: To summarise the available evidence on the diagnostic performance of clinical scores and laboratory tests for invasive candidiasis (IC) in nonneutropenic, adult critically ill patients. METHODS: A systematic review was performed to evaluate studies assessing the diagnostic performance for IC of clinical scores and/or laboratory tests vs...