American Journal of Clinical Dermatology最新文献

Background: The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD).

Objectives: To evaluate long-term effects of roflumilast foam 0.3% in patients with SD.

Methods: A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed.

Results: Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear.

Conclusions: Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks.

Clinicaltrials:

Gov listing: NCT04445987.

Background: Acne vulgaris (acne) is a common dermatological condition that can profoundly affect psychosocial well-being. Health-related quality of life (HRQoL) is an important outcome measure to assess the burden of acne in research and clinical practice.

Objective: This systematic review aimed to identify, critically appraise, and synthesize current evidence on the effects of acne on HRQoL and other psychosocial outcomes.

Methods: Structured searches of PubMed and Web of Science were conducted to identify studies measuring any HRQoL or psychosocial outcome in patients with acne vulgaris (all ages). Eligible studies were those that included ≥ 50 patients with acne, measured HRQoL or psychosocial outcomes as primary endpoints, were conducted in Europe and North America, and were published in English from 1 January 2014 to 30 April 2024. Risk of bias was assessed using the Joanna Briggs Institute (JBI) critical appraisal tools.

Results: In total, 101 studies were deemed eligible for inclusion. They varied widely in terms of study design, population, outcomes, and quality, but overall demonstrated the adverse impacts of acne on HRQoL, mental health outcomes, and the lived experiences of people with acne. Despite their heterogeneity, studies frequently found that acne predominantly affected the emotional and psychological domains of HRQoL, and was particularly burdensome to adults, females, and those with more severe acne.

Conclusions: This review collated the spectrum of impacts that acne vulgaris can impose on psychosocial well-being, and highlighted the need for consensus outcome measures to streamline future research and improve clinical practice.

Prospero registration: CRD42024539174.

Low-dose oral minoxidil has gained recognition as an off-label treatment for hair loss disorders, including androgenetic alopecia, telogen effluvium, and alopecia areata. Originally developed to treat hypertension, its hair growth-promoting effects are attributed to multiple mechanisms: primarily through direct KATP channel activation in dermal papilla cells, with additional effects from Wnt/β-catenin signaling, enhanced cysteine incorporation, and modulation of inflammatory and androgenic pathways. Clinical studies demonstrate comparable efficacy to topical minoxidil, with the added advantages of improved adherence, lower cost, and reduced application-related side effects. Common adverse effects include dose-dependent hypertrichosis (24% incidence), transient shedding (16-22%), and mild peripheral edema (2%), while serious complications, including pericardial effusion, are rare at doses used for alopecia. International Delphi consensus supports standardized dosing: 1.25 mg/day starting dose for women (range 0.625-5 mg/day) and 2.5 mg/day for men (range 1.25-5 mg/day), with lower doses recommended for adolescents and caution advised in renal/hepatic impairment. Contraindications include pericardial disease, uncontrolled hypertension, and pregnancy. While current evidence supports its safety and efficacy, further research is needed to establish long-term outcomes and optimal use in pediatric populations. With appropriate monitoring, oral minoxidil represents a promising therapeutic option in the management of hair loss disorders.

Background: Differences in atopic dermatitis (AD) prevalence, clinical presentation, and pathophysiology have been reported in different ethnic/racial groups; however, clinical trial data for patients with skin of color are limited. Tralokinumab is a monoclonal antibody that specifically targets interleukin-13, a key driver of AD.

Objectives: To investigate the efficacy and safety of tralokinumab, and examine AD biomarker expression at baseline and week 16, by self-reported racial subgroup (Asian, Black, and White) in patients with moderate-to-severe AD.

Methods: Post hoc analyses were conducted by racial subgroup using data from four phase 3 trials: placebo-controlled parent trials ECZTRA 1, 2, and 3 and the open-label extension trial ECZTEND. Endpoints included Investigator's Global Assessment (IGA) 0/1, 75% improvement in Eczema Area and Severity Index (EASI-75), and adverse events. In ECZTRA 1, serum and skin samples were analyzed for biomarker expression by immunoassay and Staphylococcus aureus (S. aureus) abundance by quantitative polymerase chain reaction (qPCR).

Results: A total of 1876 patients pooled from ECZTRA 1/2/3 (Asian/Black/White N = 407/134/1335) and 1392 patients from ECZTEND (Asian/Black/White N = 203/108/1081) were included. Baseline characteristics were largely balanced between treatment groups and racial subgroups, although AD severity was more moderate in Black patients and regional differences were observed. At week 16 of ECZTRA 1/2/3, tralokinumab improved efficacy outcomes, including IGA 0/1 and EASI-75, relative to placebo across all subgroups. Further improvements beyond week 16 were observed with continued tralokinumab treatment, including 78%, 88%, and 83% of Asian, Black, and White patients, respectively, achieving EASI-75 at week 56 of ECZTEND (corresponding to up to 2 years total tralokinumab treatment). At baseline, serum biomarker levels were elevated in Asian patients from Japan compared with other subgroups, while Asian patients from USA/Europe had lower S. aureus abundance, when adjusting for IGA. The safety profile of tralokinumab was comparable to placebo, and serious adverse events and adverse events leading to treatment discontinuation were rare, across racial subgroups.

Conclusions: Tralokinumab was well-tolerated and improved signs, symptoms, and biomarkers in patients with moderate-to-severe AD at 16 weeks across the racial subgroups studied, with further improvement in response rates up to 2 years of treatment.

Clinical trial registration: ClinicalTrials.gov identifiers: NCT03131648 (registered 24 April 2017), NCT03160885 (registered 18 May 2017), NCT03363854 (registered 01 December 2017), and NCT03587805 (registered 03 July 2018).

Enthesitis represents a hallmark feature and central pathological process in psoriatic arthritis and has been proposed as a potential early indicator in patients with psoriasis prior to the onset of clinically apparent psoriatic arthritis. Given the risks associated with delayed diagnosis, there is growing interest in identifying at-risk patients early to enable timely interventions and personalized treatment approaches. In clinical practice, dermatologists are often the first to encounter these patients, highlighting the need for effective screening strategies in their setting. In recent years, efforts have been made to develop validated screening tools for the early detection of musculoskeletal symptoms in patients with psoriasis. Additionally, there has been a greater focus on improving assessments through imaging techniques such as ultrasound and magnetic resonance imaging. However, a universally accepted referral pathway has yet to be established, potentially creating gaps in care during the transition from psoriasis to psoriatic arthritis. This review synthesizes current evidence on the role of enthesitis in psoriatic disease, focusing on its underlying mechanisms, diagnostic approaches, and therapeutic strategies. Importantly, we propose a practical screening and referral pathway designed to support dermatologists in early recognition of at-risk patients, with the goal of facilitating timely rheumatology referral and multidisciplinary management. By emphasizing the complementary roles of questionnaires, clinical assessment, and targeted imaging, our approach aims to bridge existing gaps in care and optimize patient outcomes.

This is a summary of the original article: "Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials". Chronic Hand Eczema (CHE) is a heterogeneous, multifactorial, fluctuating, and chronic inflammatory disease associated with pain, itch, and a significant quality-of-life burden for patients. The phase 3 DELTA 1 and DELTA 2 trials assessed the efficacy and safety of twice-daily delgocitinib cream 20 mg/g, a pan-Janus kinase inhibitor, compared with cream vehicle in adults with moderate to severe CHE. Delgocitinib cream demonstrated superior efficacy versus cream vehicle in outcomes reported by clinicians (e.g., Investigator's Global Assessment for CHE [IGA-CHE] treatment success [IGA-CHE 0 (clear)/1 (almost clear)] and ≥75/90% improvement in Hand Eczema Severity Index) and patients (e.g., itch, pain, and Dermatology Life Quality Index). Delgocitinib cream exhibited a favorable safety profile in both trials. These results suggest that delgocitinib cream is a treatment option for the relief of clinical signs and symptoms among patients with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.

Background: Data are limited regarding the performance of staging systems for non-head and neck cutaneous squamous cell carcinomas (non-HNCSCCs).

Objective: The aim of this study was to evaluate the performance of the Brigham and Women's Hospital (BWH) and American Joint Committee on Cancer 8th edition (AJCC8) staging system in predicting poor outcomes in non-HNCSCCs.

Patients and methods: Demographics, tumor features and stages, and outcomes for non-HNCSCCs were collected retrospectively from 11 institutions in two countries. Poor outcomes included local recurrence, metastasis, and disease-specific death; major poor outcomes excluded local recurrence. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), concordance index (c-index), and 3-year cumulative incidence were calculated. Cumulative incidence function (CIF) plots were created.

Results: 9300 non-HNCSCCs were included. Ninety-five tumors (1%) resulted in major poor outcomes; 250 (2.7%) resulted in poor outcomes. The rate of local recurrence was 1.9%, and the rate of nodal metastasis was 0.74%. Major poor outcomes were predicted with sensitivities 0.48/0.49, specificities 0.98/0.96, PPVs 0.17/0.13, NPVs 0.99/0.99, and c-indices 0.73/0.74 for BWH/AJCC8. Poor outcomes were predicted with sensitivities 0.24/0.26, specificities 0.98/0.97, PPVs 0.22/0.17, NPVs 0.98/0.98, and c-indices 0.61/0.61 for BWH/AJCC8.

Conclusions: Both systems performed similarly in predicting poor outcomes in non-HNCSCCs. Specificity and NPV were high, sensitivity and PPV were low, and c-indices were moderately high. As the c-indices were comparable to those seen in the HNCSCC literature, it is reasonable to use the BWH and AJCC8 staging systems for tumors located off the head and neck. However, further refinement of CSCC staging systems is needed to improve prognostication.