How Does the Food and Drug Administration Approve Topical Generic Drugs Applied to the Skin?
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 prospe...
Source: Dermatologic Clinics - June 1, 2022 Category: Dermatology Authors: Priyanka Ghosh, Sam G. Raney, Markham C. Luke Source Type: research
Dermatology Drugs for Children —U.S. Food and Drug Administration Perspective
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. Although legislation, clinical and pharmacological research, and analytical methods have evolved, proble...
Source: Dermatologic Clinics - June 1, 2022 Category: Dermatology Authors: Roselyn E. Epps Source Type: research
Regulation of Medical Devices for Dermatology
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 d...
Source: Dermatologic Clinics - June 1, 2022 Category: Dermatology Authors: Shlomit Halachmi, Laura Marquart Source Type: research
Measuring What Matters to Patients in Dermatology Drug Development
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 t...
Source: Dermatologic Clinics - June 1, 2022 Category: Dermatology Authors: Selena R. Daniels, Kendall A. Marcus, Robyn Bent, Elektra Papadopoulos Source Type: research
Clinical Relevance of the Microbiome in Pediatric Skin Disease: A Review
The human microbiome encompasses the microorganisms that live in and on the body. During the prenatal and infantile periods, foundations for the cutaneous and gut microbiomes are being established and refined concurrently with the development of immune function. Herein, we review the relevance of the microbiome to 5 conditions commonly encountered in pediatric dermatology: acne, alopecia areata, atopic dermatitis, psoriasis, and seborrheic dermatitis. Understanding the role microbes play in these conditions may establish the groundwork for future therapeutic interventions. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Reesa L. Monir, Jennifer J. Schoch Source Type: research
Evolving Landscape of Systemic Therapy for Pediatric Atopic Dermatitis
This article summarizes safe and effective use of systemic therapy for moderate-severe AD in pediatric patients, highlighting dupilumab and the most promising emerging treatments. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Mary Kate Lockhart, Elaine C. Siegfried Source Type: research
Clinical Decisions in Pediatric Psoriasis
Deciding when to start and selecting a specific systemic treatment for pediatric psoriasis patients can be a complex process involving many factors. Considerations include type of psoriasis, severity, potential genetic etiologies, comorbidities, triggering events and characteristics unique to each patient. The constellation of clinical features and drug related factors may prompt selection of a specific agent. Systemic treatments may be considered on the basis of those that are “tried and true” (acitretin, methotrexate, cyclosporine, phototherapy) and “new and novel” (the biologic agents). Conventional systemic age...
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Jennifer Ornelas, Kelly M. Cordoro Source Type: research
Hormonal Treatment of Acne and Hidradenitis Suppurativa in Adolescent Patients
Homeostasis of the cutaneous microenvironment is complex and depends on multiple intrinsic and extrinsic factors, including the influence of hormones. Hormones exert action on the hair follicle and associated sebaceous glands via both endocrine and intracrine mechanisms. The profound impact of hormonal action on follicular homeostasis can be leveraged in the treatment of disorders, such as acne and hidradenitis suppurativa. The clinician must have an intimate knowledge of the rationale for use, mechanism of action, and possible side effects of hormonal therapy when using these agents to treat adolescents with cutaneous dis...
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Ryan M. Svoboda, Nanjiba Nawaz, Andrea L. Zaenglein Source Type: research
Sweet Syndrome in the Pediatric Population
Pediatric Sweet syndrome (SS) is thought to be a hypersensitivity reaction to an underlying inflammatory or infectious state and typically is diagnosed using criteria created for adult patients. Although more studies are needed to understand the etiology and natural course of pediatric SS, guidelines for work-up and treatment have been suggested. Herein, the available literature is reviewed and guidelines summarized for the clinical evaluation and management of pediatric SS. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Danielle McClanahan, Tracy Funk, Alison Small Source Type: research
Morbilliform Eruptions in the Hospitalized Child
Morbilliform eruptions inspire a broad and varied differential spanning across inflammatory and infectious categories. The goal of this article is to help the clinician develop an approach toward the pediatric patient with a morbilliform eruption in the emergency room or hospital setting. The authors review several high-yield clinical scenarios with a focus on recently emerging and reemerging childhood diagnoses. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Jessica S. Haber, Sarah D. Cipriano, Vikash S. Oza Source Type: research
Supportive Oncodermatology in Pediatric Patients
Cutaneous reactions to targeted therapies are varied and common. Pediatric dermatology literature is emerging on the specific types and prevalence of cutaneous reactions to targeted therapies that hone in on membrane-bound receptors, intracellular signaling targets, and antiangiogenesis agents, as well as targeted immunotherapies. Data regarding the timing, severity, and treatment algorithms are most plentiful for BRAF, MEK, and EGFR inhibitors. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Danny W. Linggonegoro, Hannah Song, Jennifer T. Huang Source Type: research
Dermatologic Consequences of Substandard, Spurious, Falsely Labeled, Falsified, and Counterfeit Medications
This article explores dermatologic consequences of substandard, spurious, falsely labeled, falsified, and counterfeit (SSFFC) pharmaceutical products. Many of these SSFFC products are neither safe nor effective, and are more likely to cause adverse events than the proper preparations. These products also affect the health of populations by generating drug-resistant pathogens and failing to control the spread of disease. This article reviews classification systems for fraudulent medications, provides a general overview of medical and public health problems associated with substandard medications, provides examples of dermat...
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Gabrielle H. Schwartzman, Paige K. Dekker, Anna S. Silverstein, Natalia M. Fontecilla, Scott A. Norton Source Type: research
Systemic Therapy for Vascular Anomalies and the Emergence of Genotype-Guided Management
Improved understanding of the genetic basis of vascular anomalies has uncovered a growing need for targeted medical therapies. This is especially important for lesions not amenable to surgical interventions or interventional radiologic techniques. Recent studies and case reports have documented the effective use of tailored medical therapies in several distinct types of vascular anomalies. Sirolimus, mitogen-activated protein kinase inhibitors, and phosphoinositide 3-kinase inhibitors have emerged as potential therapies. Although this remains a growing field with significant knowledge gaps, a more optimistic outlook for pa...
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Cynthia L. Nicholson, Sheilagh M. Maguiness Source Type: research
Laser Surgery for Dermatologic Conditions in Pediatric Patients
Laser therapy is an effective treatment that can be used in a wide range of cutaneous conditions in pediatric dermatology. It is an important tool to have in one ’s armamentarium. The parameters within each laser can vary greatly by the make and model of the laser, making it difficult to make settings generalizable. The goal of this article is to provide some general guiding principles for laser choice, theory behind laser parameter choice, and education s urrounding tissue response which will guide treatment parameter changes. (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Deepti Gupta Source Type: research
Pediatric Dermatology Part II
DERMATOLOGIC CLINICS (Source: Dermatologic Clinics)
Source: Dermatologic Clinics - March 31, 2022 Category: Dermatology Authors: Kelly M. Cordoro Source Type: research
