Knowledge, Attitudes, and Perceptions of Skin Cancer Clinical Trials in the Hispanic Population.

OBJECTIVE: To determine the factors that might limit Hispanic patients from participating in dermatological clinical trials. METHODS: From January 2022 to July 2022, we administered a 31-item, in-person questionnaire to patients recruited in the waiting area of the Caridad Center, one of the largest free clinics in the United States with a predominately Hispanic population, and a nearby private primary care clinic. RESULTS: Overall, Hispanic patients agreed significantly more with statements in the domain of attitude and behavioral beliefs compared to non-Hispanic survey respondents. The Hispanic ethnicity was associated with increased odds of agreeing with the following statements: "My community would really benefit from skin cancer clinical trials" (OR=0.52; 95% CI 0.30, 0.92), "My participation in a skin cancer study would be very good" (OR=0.59; 95% CI 0.35, 0.99), and "I like to do good for others" (OR=0.41; 95% CI 0.22, 0.77). CONCLUSION: While the United States population is composed of 18.5% Hispanics, they only account for 1% of patients enrolled in clinical trials. This study helps identify potential motivational factors for Hispanic patients to participate in skin cancer clinical trials.

Management of Acute Wounds - Expert Panel Consensus Statement.

SIGNIFICANCE: The Wound Healing Foundation recognized the need for consensus-based unbiased recommendations for the treatment of wounds. As a first step, a consensus on the treatment of chronic wounds was developed and published in 2022.(1) The current publication on acute wounds represents the second step in this process. Acute wounds may result from any number of conditions, including burns, military and combat operations, and trauma to specific areas of the body. The management of acute wounds requires timely and evidence-driven intervention to achieve optimal clinical outcomes. This consensus statement provides the clinician with the necessary foundational approaches to the causes, diagnosis and therapeutic management of acute wounds. Presented in a structured format, this is a useful guide for clinicians and learners in all patient care settings. RECENT ADVANCES: Recent advances in the management of acute wounds have centered on stabilization and treatment in the military and combat environment, Specifically advancements in hemostasis, resuscitation, and the mitigation of infection risk through timely initiation of antibiotics and avoidance of high pressure irrigation in contaminated soft tissue injury. . CRITICAL ISSUES: Critical issues include infection control, pain management and the unique considerations for the management of acute wounds in pediatric patients. FUTURE DIRECTIONS: Future directions include new approaches to preventing the progression and conversion of burns through the use of the microcapillary gel, a topical gel embedded with the anti-inflammatory drug infliximab.(38) Additionally, the use of three-dimensional bioprinting and photo-modulation for skin reconstruction following burns is a promising area for continued discovery.

Atypical Fibroxanthoma Treated with a Topical Combination of Imiquimod, Tazarotene, and 5-Fluorouracil.

This case report describes an 80-year-old man who presented with a growing erythematous nodule with erosion, measuring 0.6 cm × 0.6 cm, on his right temple. This lesion was later diagnosed as atypical fibroxanthoma (AFX). Instead of undergoing Mohs surgery, the gold standard treatment, the patient opted to pursue a topical treatment regimen because of financial costs associated with surgical removal and repair. This topical regimen consisted of tazarotene cream, imiquimod cream, and 5-fluorouracil solution, applied for 30 days. The patient was directed to use this combination 5 days per week for 6 weeks. The specified dosage for each medication was a fifth of a packet of imiquimod 5% cream, an equivalent amount of tazarotene 0.1% cream, and a single drop of 5-fluorouracil 2% solution. These were combined on a bandage and placed on the lesion overnight. Following the treatment, a 3-week post-application examination revealed an erosion, 1.0 cm × 0.9 cm, amidst erythema. A subsequent incisional biopsy with histopathology and stains for CD10 and CD99, 3 weeks after treatment, and three punch biopsies with histopathology and stains for CD10 and CD99, 1-year post-treatment, confirmed the absence of AFX. AFX is a superficial variant of pleomorphic dermal sarcoma (PDS), which shares histologic similarities, yet the exact relationship between AFX/PDS and undifferentiated pleomorphic sarcoma is still not well understood. Previous studies have indicated a genomic similarity between AFX/PDS and cutaneous squamous cell carcinoma (cSCC), which suggests the potential efficacy of cSCC-targeted treatments for AFX/PDS. This case marks the first recorded instance of successful topical medical treatment of AFX, offering an alternative for patients who may opt out of surgical intervention. Continued research to assess the broader efficacy of this approach is encouraged.

Diabetic Foot Ulcers: A Review of Debridement Techniques.

Diabetic foot ulcers (DFUs) are a prevalent complication of diabetes mellitus (DM) and lead to significant morbidity and mortality. Patients with DM have a lifetime risk of DFUs as high as 34%. The pathogenesis of DFUs is multifactorial, and the most common underlying causes are poor glycemic control, peripheral neuropathy, peripheral vascular disease, foot deformity, and poor foot care. Diabetic lower-extremity complications are also a significant burden in terms of healthcare costs. In the United States alone, the direct cost of diabetic foot care has been estimated to be $8,659 per patient, with total annual medical costs for managing diabetic foot disease ranging from $9 to $13 billion. Given the risk of amputation and poor wound healing, the fast, accurate diagnosis and treatment of DFUs are critical. Measures to prevent DFUs include glycemic control and annual foot inspections. For patients with DFUs, off-loading and local wound care are critical for wound healing. Debridement is the standard of care for DFU wounds, and several techniques exist. In this review, we discuss the current practices of diabetic wound care, different methods of debridement and their practical use in DFUs, and novel debridement approaches with the potential for improving wound-healing outcomes.

Efficacy and safety of crisaborole ointment, 2%, in participants aged ≥45 years with stasis dermatitis: Results from a fully decentralized, randomized, proof-of-concept phase 2a study.

BACKGROUND: Crisaborole ointment, 2%, is a nonsteroidal topical phosphodiesterase 4 inhibitor approved for the treatment of mild-to-moderate atopic dermatitis. OBJECTIVE: To evaluate the efficacy and safety of crisaborole in stasis dermatitis (SD). METHODS: In this randomized, double-blind, vehicle-controlled, decentralized phase 2a study (NCT04091087), 65 participants aged ≥45 years with SD without active ulceration received crisaborole or vehicle (1:1) twice-daily for 6 weeks. The primary end point was percentage change from baseline in total sign score at week 6 based on in-person assessment. RESULTS: Crisaborole-treated participants had significantly reduced total sign score from baseline versus vehicle based on in-person (nondermatologist) assessment (-32.4% vs -18.1%, P = .0299) and central reader (dermatologists) assessment of photographs (-52.5% vs -10.3%, P = .0004). Efficacy according to success and improvement per Investigator's Global Assessment score and lesional percentage body surface area reached statistical significance based on central reader but not in-person assessments. Skin and subcutaneous tissue disorders were common all-causality treatment-emergent adverse events with crisaborole. LIMITATIONS: Small sample size and short treatment duration were key limitations. In-person assessment was not conducted by dermatologists. CONCLUSION: Crisaborole improved signs and symptoms of SD and was well tolerated. Central reader assessment represents a promising approach for siteless clinical research.

Improvement of Chronic Venous Insufficiency Related Leg Xerosis and Dermatitis With Ceramide-Containing Cleansers and Moisturizers: An Expert-Based Consensus.

INTRODUCTION: Chronic venous insufficiency (CVI) may lead to sustained elevated pressure (aka venous hypertension) in the dermal venous microcirculation. Risk factors include advanced age, obesity, female gender, pregnancy, and prolonged standing. CVI in the lower extremities may lead to cutaneous changes such as xerosis and venous leg dermatitis (VLD). This review explores skin barrier restoration using skincare for xerosis and VLD.    Methods: Prior to the meeting, a structured literature search yielded information on fourteen draft statements. During the meeting, a multi-disciplinary group of experts adopted five statements on xerosis and VLD supported by the literature and the authors’ clinical expertise.   Results: VLD and associated xerosis is a common condition requiring more attention from healthcare providers. Compression therapy is the standard CVI and should be combined with good-quality skincare to enhance adherence to treatment. Maintaining an intact skin barrier by preventing and treating xerosis using gentle cleansers and ceramide-containing moisturizers may improve the skin sequelae of CVI. Skincare is frequently lacking or overlooked as part of the treatment of patients with CVI and VLD. This skin treatment is an unmet need that can be addressed with ceramides-containing pH balanced cleansers and moisturizers. CONCLUSION: Compression therapy is the mainstay of treatment for CVI and VLD. Quality skincare can improve treatment adherence and the efficacy of compression therapy. Using a skincare agent may reduce friction and help patients avoid skin trauma while putting on compression garments. A ceramide-containing moisturizer sustained significant improvements in skin moisturization for 24 hours and may offer synergistic benefits together with compression treatment.  J Drugs Dermatol. 2024;23(2):61-66.     doi:10.36849/JDD.7588.

Current Status and Principles for the Treatment and Prevention of Diabetic Foot Ulcers in the Cardiovascular Patient Population: A Scientific Statement From the American Heart Association.

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

Consensus recommendations for optimizing the use of intact fish skin graft in the management of acute and chronic lower extremity wounds.

BACKGROUND: Since 2017, the clinical use of IFSG has increased substantially in the United States, with some use in Europe and Asia as well. However, scant consensus data have been published on such use. OBJECTIVE: The authors sought to develop consensus recommendations for the clinical use of IFSG in the management of acute and chronic LEWs. METHODS: A panel of 8 expert clinicians in the United States used a 2-cycle NFG process to develop consensus statements based on their own clinical practice and the literature. At their initial meeting in October 2021, panel members discussed the management of DFUs, VLUs, atypical LEWs, and traumatic LEWs in their practices. Consensus statements were drafted, voted on, and rated by relative importance. At the second meeting in October 2022, the panel discussed the initial survey results; a second survey was conducted, and panel members revised the recommendations and indicated the relative importance of each in the final report. A systematic literature review of English-language articles published from January 2016 through November 2022 was conducted as well, using the search terms: "fish skin," "piscine graft," "fish tissue," "intact fish skin graft," "Cod skin," "Omega 3 fatty acid graft." RESULTS: Forty-three statements were generated and grouped into 5 sections comprising general recommendations for LEWs and recommendations specific to DFUs, VLUs, atypical LEWs, and traumatic LEWs. The primary general recommendation is the need to determine wound etiology based on clinical evaluation and reviewing related test results. For DFUs and VLUs, the main recommendations are to adhere to first-line therapy (ie, standard of care, follow conventional guidelines [multilayer compression therapy], offloading, and assessment of wound perfusion) before introducing IFSG. CONCLUSIONS: Publications on and clinical experience in the use of IFSGs have increased substantially in the past several years. The 43 consensus recommendations are meant to guide physicians in the optimal use of IFSG in the management of acute and chronic LEWs.

Skin substitutes as treatment for chronic wounds: current and future directions.

Chronic wounds such as diabetic foot ulcers and venous leg ulcers place a significant burden on the healthcare system and in some cases, have 5-year mortality rates comparable to cancer. They negatively impact patients' quality of life due to pain, odor, decreased mobility, and social isolation. Skin substitutes are an advanced therapy recommended for wounds that fail to show decrease in size with standard care. The choice of substitute used should be based on evidence, which often differs based on wound etiology. There are more than 75 skin substitutes currently available, and that number is rising. In this review, we discuss current management and future directions of chronic wounds while providing a review of available randomized control trial data for various skin substitutes.

Keratinocyte Carcinoma Chemoprevention With a Combination of Imiquimod, 5-Fluorouracil, and Tretinoin.

BACKGROUND: The incidence of keratinocyte carcinomas (KCs), comprising basal and squamous cell carcinomas, is rising in the United States. Chemoprevention is one modality by which patients can reduce the incidence of KCs. METHODS: We performed a retrospective review of 327 patients who employed a combination of imiquimod 5% cream, 5-fluorouracil 2% solution, and tretinoin 0.1% cream in a field therapy regimen over the face/ears or scalp for chemoprevention. RESULTS: Patients had dramatically lower odds of having KCs in the treatment location (face/ears or scalp) in the one-year period after field treatment than in the one-year period preceding field treatment (OR=0.06, 95% CI: [0.02, 0.15]). Patients were also at lower odds of having KCs in non-treated areas the year after field treatment than in the year preceding it (OR=0.25, 95% CI: [0.14, 0.42]). Additionally, fewer cryotherapy sessions were performed for actinic keratoses in the treatment areas in the year after treatment (mean=1.5, SD=1.21) than the year preceding treatment (mean=2.3, SD=0.99; t=11.68, P<0.001). CONCLUSIONS: A combination of imiquimod 5% cream, 5-fluorouracil 2% solution, and tretinoin 0.1% cream were effective at reducing the incidence of new KCs for at least one year. Individualized treatment application frequency allowed for increased patient adherence. Prospective studies evaluating combination topical treatments for chemoprevention of KCs are needed to further assess the treatment effects found in this study. J Drugs Dermatol. 2023;22(5): doi:10.36849/JDD.7334.

Algorithm to Improve Patient Comfort and Treat Diabetes Mellitus-Related Xerosis.

BACKGROUND: Diabetes mellitus (DM)-related cutaneous disorders such as xerosis frequently occur in patients with type 1 and type 2 diabetes. Gentle cleansers and moisturizers are underused to prevent xerosis or provide effective early treatment and maintenance. METHODS: The project used a modified Delphi hybrid process comprising face-to-face discussions followed by an online review process. A panel of physicians who treat patients with diabetes with DM used information from literature searches coupled with expert opinions and their experience to develop a practical algorithm to improve outcomes for patients with DM-related xerosis. RESULTS: The algorithm for DM-related xerosis aims to inform dermatologists and other health care professionals caring for patients with DM. The first section of the algorithm addresses education and behavioral measures. Treatment adherence is a considerable challenge in people with DM, making education essential. The second section discusses the assessment of the skin condition. The third section reports on an interdisciplinary team-based approach to patients with DM-related xerosis. The algorithm describes treatment and maintenance approaches using cleansers and moisturizers for mild, moderate, and severe xerosis, distinguishing between the body, face, hands, and feet. CONCLUSION: The algorithm supports educating health care professionals and patients on xerosis prevention and treatment using ceramides-containing gentle cleansers and moisturizers to improve patient comfort and prevent complications. J Drugs Dermatol. 2023;22(4): doi:10.36849/JDD.7177 Citation: Kirsner RS, Andriessen A, Hanft JR, et al. Algorithm to improve patient comfort and treat diabetes mellitus-related xerosis. J Drugs Dermatol. 2023;22(4):356-363. doi:10.36849/JDD.7177.

Narrative Review of the Pathogenesis of Stasis Dermatitis: An Inflammatory Skin Manifestation of Venous Hypertension.

INTRODUCTION: Stasis dermatitis (SD), also known as venous dermatitis, is a form of inflammatory dermatitis of the lower extremities that typically occurs in older individuals and represents a cutaneous manifestation of venous hypertension. Venous hypertension (also known as sustained ambulatory venous pressure) is most often due to retrograde blood flow, which occurs due to calf muscle pump failure. This failure is most commonly secondary to incompetent venous valves, valve destruction, or obstruction of the venous system. Many of the common symptoms associated with SD are caused by inflammatory processes. METHODS: This review summarizes the pathogenesis and key role of inflammation in SD by reviewing inflammatory biomarkers associated with SD. The literature was selected though a high-level PubMed search focusing on keywords relating to inflammation associated with SD. RESULTS: Venous reflux at the lower extremities causes venous hypertension, which leads to chronic venous insufficiency. High venous pressure due to venous hypertension promotes the local accumulation and extravasation of inflammatory cells across the vascular endothelium. Leukocyte trapping in the microcirculation and perivascular space is associated with trophic skin changes. Cell adhesion molecules are linked with the perpetuated influx of activated leukocytes into inflammatory sites. Here, inflammatory cells may influence the remodeling of the extracellular matrix by inducing the secretion of proteinases such as matrix metalloproteinases (MMPs). The increased expression of MMPs is associated with the formation of venous leg ulcers and lesions. Phosphodiesterase 4 activity has also been shown to be elevated in individuals with inflammatory dermatoses compared to healthy individuals. DISCUSSION: Because inflammation is a key driver of the signs and symptoms of SD, several of the highlighted biomarkers of inflammation represent potential opportunities to target and interrupt molecular pathways of cutaneous inflammation and, therefore, remediate the signs and symptoms of SD. CONCLUSION: Understanding the pathogenesis of SD may help clinicians identify drivers of inflammation to use as potential targets for the development of new treatment options.

Stasis dermatitis is a skin disease that affects the legs, most often of older people, with chronic venous insufficiency. Chronic venous insufficiency is when veins cannot return blood from the legs back to the heart. This leads to high blood pressure in veins and causes blood in those veins to flow backwards. If stasis dermatitis is left untreated, complications, including skin ulcers, can result. Other skin symptoms of stasis dermatitis include itchiness, scaling, and discoloration. Such skin symptoms can have a negative effect on a person's quality of life. Inflammation that lasts a long time is likely the main link between the skin changes seen in people with stasis dermatitis and the increased pressure in leg veins. Several molecules are associated with the inflammation observed in stasis dermatitis, including white blood cells, matrix metalloproteinases, phosphodiesterase 4, and interleukin-31. Treatment for stasis dermatitis should focus both on the underlying chronic venous insufficiency and the associated skin issues. Identifying inflammatory markers and pathways could help treat the signs and symptoms associated with stasis dermatitis, including the skin symptoms.

Periorbital Pyoderma Gangrenosum Associated With a Cocaine-Induced Midline Destructive Lesion: Case Report and Review of the Literature.

A 72-year-old woman with a history of chronic cocaine use presented 9 months after a dog bite with a large facial ulceration and absent sinonasal structures. Biopsies were negative for infectious, vasculitic, or neoplastic pathologies. The patient was lost to follow up for 15 months and returned with a significantly larger lesion despite abstinence from cocaine. Additional inflammatory and infectious workup was negative. Intravenous steroids were administered with clinical improvement. Therefore, she was diagnosed with pyoderma gangrenosum and cocaine-induced midline destructive lesion due to cocaine/levamisole. Pyoderma gangrenosum is a rare dermatologic condition that uncommonly involves the eye and ocular adnexa. Diagnosis involves clinical examination, response to steroids, exclusion of infectious or autoimmune conditions, and identifying potential triggers including cocaine/levamisole. This report highlights a rare presentation of periorbital pyoderma gangrenosum causing cicatricial ectropion associated with concomitant cocaine-induced midline destructive lesion and reviews important aspects of clinical manifestations, diagnosis, and management of pyoderma gangrenosum and cocaine/levamisole autoimmune phenomenon.

Supplement Individual Article: The Importance of a Healthy Skin Barrier From the Cradle to the Grave Using Ceramide-Containing Cleansers and Moisturizers: A Review and Consensus.

INTRODUCTION: Inflammatory skin disorders compromise skin barrier health. Early and daily skincare use aims to maintain a life-long healthy skin barrier. Racial/ethnic and age variations in skin barrier properties, cultural differences, and clinical presentation of the inflammatory skin disorder influence the choice of treatment and skin care. Ceramide-containing skin care may play a role in restoring and maintaining a healthy skin barrier. METHODS: A panel of 6 dermatologists met to develop consensus statements based on their 8 previous publications on promoting skin barrier health throughout life using ceramide-containing skin care. The publications covered skin barrier integrity in the newborn and infant, and the role of the skin barrier in mitigating atopic dermatitis (AD); racial/ethnic variations in the skin barrier and implications for skin care; the role of the skin barrier in inflammatory skin conditions including acne, AD and psoriasis in skin of color (SOC) populations; skin barrier integrity in patients with rosacea; and xerosis in patients with diabetes mellitus. The panel synthesized the 8 publications, selected information from a literature review, and their expert opinions and experiences to create the statements. The consensus was reached through a modified Delphi method where the panel met face-to-face and followed up virtually. RESULTS: The panel adopted 6 consensus statements highlighting the importance of skin care in restoring/maintaining a healthy skin barrier in the populations mentioned above. Skin care suited to this role is gentle, has near-physiologic pH, is pleasant to use, and contains ceramides. This type of skin care can promote a healthy skin barrier and attenuate or delay inflammatory skin conditions. CONCLUSIONS: Adjunctive daily skin care throughout life promotes a healthy skin barrier and is beneficial in managing various inflammatory skin disorders in all populations. However, when choosing optimal treatment and skin care, physicians should consider variations in age, skin properties, presentation of the condition, and cultural differences. J Drugs Dermatol. 2023;22:2(Suppl 1):s3-14.