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Experiences of Cutaneous Immune-Related Adverse Events: A Qualitative Study in Patients With Cancer Receiving Immune Checkpoint Inhibitors 皮肤免疫相关不良事件的经验:接受免疫检查点抑制剂的癌症患者的定性研究
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-06-11 DOI: 10.1155/dth/7119579
Zhihui Yang, Ruiqi Lu, Xingwen Li, Suting Liu, Yuanyuan Luo, Ziqi Wang, Yang Zhao, Lili Zhang

Background: Cutaneous immune-related adverse events (cirAEs) represent a prevalent manifestation of adverse reactions linked to immune checkpoint inhibitors (ICIs) therapy, substantially affecting patients’ quality of life.

Objective: To describe the symptomatic experience of cirAEs in patients with cancer receiving ICIs.

Design: Qualitative interviews on experiences were conducted from the perspective of patients with cancer.

Methods: A purposive sample of 18 patients with cirAEs participated in this semistructured interview. Transcripts were entered into Nvivo 11.0. Qualitative content analysis was used to analyze the data for significant statements and phrases, which were organized into themes and subthemes.

Results: Three main themes were identified in the data: (i) multiple emotions coexist, affecting the quality of life; (ii) insufficient coping capacity for cirAEs management; and (iii) exploring needs and expectations for management with cirAEs.

Conclusions: The results of this study enable healthcare providers to better understand and empathize with the patient’s experience, to truly practice the essence of patient-centered care, and to provide a basis for the development of standardized symptom management programs in the future.

Implications for Clinical Practice: To strengthen patient education by clarifying knowledge of cirAEs and providing evidence-based coping strategies, formulate personalized management plans supported by multidisciplinary collaboration when necessary, establish standardized symptom management protocols incorporating regular monitoring and dynamic strategy adjustments, and promote patient participation in decision-making while building support networks to enhance self-efficacy, thereby laying the foundation for future standardized management protocols through patient-centered integrated management approaches.

背景:皮肤免疫相关不良事件(cirae)是与免疫检查点抑制剂(ICIs)治疗相关的不良反应的普遍表现,严重影响患者的生活质量。目的:描述接受体外循环治疗的癌症患者发生cirae的症状体验。设计:从癌症患者的角度对经历进行定性访谈。方法:有目的的18例cirae患者参加了半结构化访谈。转录本输入Nvivo 11.0。采用定性内容分析法对重要语句和短语进行数据分析,并将其组织成主题和副主题。结果:在数据中确定了三个主要主题:(i)多种情绪并存,影响生活质量;(二)cirae管理应对能力不足;(三)探索对cirae管理的需求和期望。结论:本研究结果使医护人员能够更好地理解和体会患者的感受,真正践行以患者为中心的护理精神,为今后制定规范化的症状管理方案提供依据。对临床实践的启示:通过宣讲cirae知识、提供循证应对策略等方式加强患者教育,必要时制定个性化的多学科协作管理方案,建立规范化的症状管理方案,定期监测、动态调整策略,促进患者参与决策,构建支持网络,提升自我效能感。从而通过以患者为中心的综合管理方法为未来的标准化管理方案奠定基础。
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引用次数: 0
Pruritus and Its Association With Cancer and Mortality in Dermatomyositis and Polymyositis: A Nationwide Cohort Study in Taiwan From 2005 to 2022 皮肤肌炎及多发性肌炎患者瘙痒及其与癌症及死亡率的关系:台湾2005年至2022年的全国性队列研究
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-06-09 DOI: 10.1155/dth/9963667
Der-Jr Huang, Yu-Hsuan Joni Shao, Yi-Hsien Shih, Woan-Ruoh Lee, Ling-Ya Huang, Yu-Min Kuo, Quoc Thao Trang Pham, Hao-Jui Weng

Background: Pruritus is the most common initial symptom reported by patients with dermatomyositis (DM) and polymyositis (PM). However, there is limited data regarding the impact of pruritus on cancer and mortality in patients with DM and PM. In this study, we aimed to investigate how pruritus is associated with cancer and mortality in patients with DM and PM.

Methods: This nationwide, population-based retrospective cohort study included adult DM and PM patients from Taiwan’s National Health Insurance Research Database between 2005 and 2022. Sex- and age-matched pruritic patients, identified by over 6 weeks of antipruritic medication use, and nonpruritic patients were analyzed. The primary outcome was cancer occurrence or all-cause mortality. The association between pruritus and these outcomes was estimated using Cox proportional hazards models.

Results: Among 919 matched pairs of pruritic and nonpruritic patients, cancer was observed in 19.96% in the long-term pruritic group (LPG), 14.63% in the short-term pruritic group (SPG), and 10.34% in the non-pruritic group (NPG) (p < 0.0001). All-cause mortality was documented as 30.37% in the LPG, 29.69% in the SPG, and 37.76% in the NPG (p < 0.0001). After adjusting for sex, age, and other comorbidities, pruritus was associated with an increased risk of cancer (hazard ratio (HR) 1.708, 95% confidence interval (CI) 1.229–2.374) and a lower risk of all-cause mortality (HR 0.483, 95% CI 0.409–0.569).

Conclusion: This population-based study revealed that pruritus appeared to be associated with increased risks of cancer and decreased all-cause mortality. Thus, pruritus may serve as a pragmatic factor for risk stratification and tailored treatment strategies in DM and PM. Cancer screening, particularly for nasopharyngeal and breast cancers in East Asian populations, is recommended for patients with DM or PM, especially those presenting with pruritus. Meanwhile, patients without pruritus may require vigilant management for potentially life-threatening complications and comorbidities.

背景:瘙痒是皮肌炎(DM)和多发性肌炎(PM)患者最常见的首发症状。然而,关于瘙痒对糖尿病和PM患者的癌症和死亡率的影响的数据有限。在这项研究中,我们旨在探讨瘙痒与糖尿病和PM患者的癌症和死亡率之间的关系。方法:这项全国性的、以人群为基础的回顾性队列研究纳入了2005年至2022年间来自台湾全民健康保险研究数据库的成年糖尿病和PM患者。分析了性别和年龄匹配的瘙痒患者,通过使用6周以上的止痒药物来确定,以及非瘙痒患者。主要结局是癌症发生率或全因死亡率。使用Cox比例风险模型估计瘙痒与这些结果之间的关系。结果:在919对瘙痒性和非瘙痒性患者中,长期瘙痒组(LPG)的癌症发生率为19.96%,短期瘙痒组(SPG)的癌症发生率为14.63%,非瘙痒性组(NPG)的癌症发生率为10.34% (p <;0.0001)。LPG组的全因死亡率为30.37%,SPG组为29.69%,NPG组为37.76% (p <;0.0001)。在对性别、年龄和其他合共病进行校正后,瘙痒与癌症风险增加(风险比(HR) 1.708, 95%可信区间(CI) 1.229-2.374)和全因死亡风险降低(HR 0.483, 95% CI 0.409-0.569)相关。结论:这项基于人群的研究显示,瘙痒似乎与癌症风险增加和全因死亡率降低有关。因此,瘙痒可以作为DM和PM的风险分层和定制治疗策略的实用因素。对于糖尿病或PM患者,特别是伴有瘙痒的患者,建议进行癌症筛查,特别是东亚人群的鼻咽癌和乳腺癌筛查。同时,没有瘙痒的患者可能需要警惕潜在的危及生命的并发症和合并症的管理。
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引用次数: 0
Phospholipid Detection From Surgical Smoke Distinguishes Basal Cell Carcinoma: A Proof-of-Principle Study 从手术烟雾中检测磷脂可区分基底细胞癌:一项原理证明研究
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-06-08 DOI: 10.1155/dth/6179799
Anni Salminen, Patrik Sioris, Juha Jernman, Nele Veide, Anton Kontunen, Meri Mäkelä, Markus Karjalainen, Minna Kelloniemi, Niku Oksala, Antti Roine

Background: Basal cell carcinoma (BCC) is a nonmelanocytic skin cancer and the most common malignancy in Caucasians. Diagnostics and treatment of BCC cause significant health-related stress for many patients and costs for public health care systems. Differential mobility spectrometry (DMS) is a sensitive method for detection of gaseous molecules. The DMS-derived automatic tissue analysis system (ATAS) utilises diathermy-generated surgical smoke to distinguish cancerous tissue from normal tissue based on lipid profiling between the tissues.

Objectives: The aim of this study was to create a surrogate porcine model to test the feasibility of the ATAS in lipid detection of skin. Another objective was to determine whether BCC of human skin could be identified from healthy skin using lipid profiling.

Methods: Porcine ear skin was used to establish a three-group porcine model for lipid profile detection. Lecithin was chosen as a marker to demonstrate elevated phospholipid levels in one of the groups. We also recruited five BCC patients to collect BCC tumour biopsies and healthy skin biopsies to test the model in human samples. In both models, all samples were processed with the ATAS to test the accuracy of lipid profiling and resolution between the groups.

Results: In the porcine model, the classification accuracy was 74.5% for three groups (unprocessed porcine skin, fine-grained porcine skin, and lecithin-marked fine-grained porcine skin) and 91.8% for two groups (unprocessed porcine skin and fine-grained porcine skin combined into one group in comparison to lecithin-marked fine-grained porcine skin). The support vector machine (SVM) classifier model trained on porcine surrogate samples was then used to analyse a small number of human BCC and healthy skin samples with 95% accuracy.

Conclusion: DMS-based differentiation of porcine skin samples based on surgical smoke is possible. This study is a step towards a method to distinguish human BCC from healthy skin from surgical smoke by the ATAS. The presented skin identification of DMS analysis of surgical smoke opens the possibility to research the method in a larger sample number of human BCC and healthy skin samples as well as develop the method and ATAS towards a clinical tool for margin assessment.

背景:基底细胞癌(BCC)是一种非黑素细胞性皮肤癌,是白种人中最常见的恶性肿瘤。BCC的诊断和治疗给许多患者带来了重大的健康相关压力,并增加了公共卫生保健系统的成本。差分迁移率光谱法(DMS)是一种灵敏的气体分子检测方法。dms衍生的自动组织分析系统(ATAS)利用透热产生的手术烟雾根据组织之间的脂质谱来区分癌组织和正常组织。目的:建立替代猪模型,验证ATAS在皮肤脂质检测中的可行性。另一个目的是确定是否可以通过脂质分析从健康皮肤中识别人类皮肤的BCC。方法:采用猪耳皮建立三组猪模型进行脂质谱检测。选择卵磷脂作为标记来证明其中一组的磷脂水平升高。我们还招募了5名BCC患者,收集BCC肿瘤活检和健康皮肤活检,以在人体样本中测试模型。在这两种模型中,所有样品都用ATAS处理,以测试脂质分析的准确性和组间分辨率。结果:在猪模型中,与卵磷脂标记的细粒猪皮相比,三组(未加工猪皮、细粒猪皮和卵磷脂标记的细粒猪皮)的分类准确率为74.5%,两组(未加工猪皮和细粒猪皮合并一组)的分类准确率为91.8%。然后,使用在猪替代样本上训练的支持向量机(SVM)分类器模型对少量人类BCC和健康皮肤样本进行分析,准确率为95%。结论:基于手术烟雾的猪皮肤样本的dms鉴别是可行的。本研究是利用ATAS区分人类基底细胞癌、健康皮肤和手术烟雾的一步。所提出的手术烟雾DMS皮肤识别分析为在更大样本数量的人类基底细胞癌和健康皮肤样本中研究该方法提供了可能性,并将该方法和ATAS发展为边缘评估的临床工具。
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引用次数: 0
Nonablative Er:YAG Laser Treatment of Androgenetic Alopecia: A Clinical Observation 非消融性Er:YAG激光治疗雄激素性脱发的临床观察
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-06-02 DOI: 10.1155/dth/2419414
Qiongyu Zhang, Enpin Yang, Lin Cong, Xuesong Yang, Jianzhou Ye, Wenbin Zhao, Guilan Hu, Iva Talaber

Background and Aim: Androgenetic alopecia (AGA) is a common hair disorder with a low cure rate. Nonablative Er:YAG laser therapy is a novel treatment modality for AGA, representing an alternative to pharmacological and surgical treatment. To date, several small scale studies employing this laser treatment have demonstrated good results but the evidence is still limited. The aim of this study was to evaluate effectiveness and safety of a nonablative 2940 nm Er:YAG laser for treating AGA in female and male patients with both early and advanced stages of AGA.

Methods: Patients (22 male and 10 female) with active AGA were treated with 2940 nm nonablative Er:YAG laser (SMOOTH™ mode, 7 mm spot size, 7.5–10 J/cm2, and frequency 2.5 Hz). Efficacy of treatment was evaluated clinically on a scale of 0–10 and with blind evaluation of hair appearance as seen in global photographs. Global photographs were taken before treatment and at 1-month follow-up and evaluated on a 5-point scale. Patient satisfaction was evaluated with a questionnaire on a scale from 0 to 3 and pain during treatment was evaluated with a pain scale from 0 to 10.

Results: Median clinical improvement was 6 (1–9), median satisfaction score was 3 (0–3), and median pain degree was 3 (0–10). According to blind evaluation, hair appearance at the 1-month FU was better in 63% and much better in 9% of the patients compared with the baseline. No adverse reactions were reported.

Conclusions: The results of this study corroborate the effectiveness of treatment with nonablative Er:YAG laser therapy for AGA. Six biweekly sessions resulted in general patient satisfaction and visible improvement in hair appearance.

背景与目的:雄激素性脱发(AGA)是一种常见的头发疾病,治愈率低。非消融Er:YAG激光治疗是AGA的一种新型治疗方式,代表了药物和手术治疗的替代方案。迄今为止,几项采用这种激光治疗的小规模研究已经显示出良好的效果,但证据仍然有限。本研究的目的是评估非烧蚀性2940 nm Er:YAG激光治疗早期和晚期AGA女性和男性患者的有效性和安全性。方法:采用2940 nm非烧蚀性Er:YAG激光(SMOOTH™模式,光斑尺寸7 mm, 7.5-10 J/cm2,频率2.5 Hz)治疗活动性AGA患者(男22例,女10例)。临床评估治疗效果,评分为0-10分,并对头发外观进行盲评,如全球照片所示。在治疗前和随访1个月时拍摄全球照片,并以5分制进行评估。采用0 - 3分的调查问卷对患者满意度进行评估,并采用0 - 10分的疼痛量表对治疗期间的疼痛进行评估。结果:临床改善中位数为6(1-9),满意度中位数为3(0-3),疼痛程度中位数为3(0-10)。根据盲法评估,与基线相比,1个月FU时,63%的患者头发外观更好,9%的患者更好。无不良反应报告。结论:本研究结果证实了非烧蚀Er:YAG激光治疗AGA的有效性。6次每两周一次的治疗使患者总体满意,头发外观也有了明显的改善。
{"title":"Nonablative Er:YAG Laser Treatment of Androgenetic Alopecia: A Clinical Observation","authors":"Qiongyu Zhang,&nbsp;Enpin Yang,&nbsp;Lin Cong,&nbsp;Xuesong Yang,&nbsp;Jianzhou Ye,&nbsp;Wenbin Zhao,&nbsp;Guilan Hu,&nbsp;Iva Talaber","doi":"10.1155/dth/2419414","DOIUrl":"https://doi.org/10.1155/dth/2419414","url":null,"abstract":"<div>\u0000 <p><b>Background and Aim:</b> Androgenetic alopecia (AGA) is a common hair disorder with a low cure rate. Nonablative Er:YAG laser therapy is a novel treatment modality for AGA, representing an alternative to pharmacological and surgical treatment. To date, several small scale studies employing this laser treatment have demonstrated good results but the evidence is still limited. The aim of this study was to evaluate effectiveness and safety of a nonablative 2940 nm Er:YAG laser for treating AGA in female and male patients with both early and advanced stages of AGA.</p>\u0000 <p><b>Methods:</b> Patients (22 male and 10 female) with active AGA were treated with 2940 nm nonablative Er:YAG laser (SMOOTH™ mode, 7 mm spot size, 7.5–10 J/cm<sup>2</sup>, and frequency 2.5 Hz). Efficacy of treatment was evaluated clinically on a scale of 0–10 and with blind evaluation of hair appearance as seen in global photographs. Global photographs were taken before treatment and at 1-month follow-up and evaluated on a 5-point scale. Patient satisfaction was evaluated with a questionnaire on a scale from 0 to 3 and pain during treatment was evaluated with a pain scale from 0 to 10.</p>\u0000 <p><b>Results:</b> Median clinical improvement was 6 (1–9), median satisfaction score was 3 (0–3), and median pain degree was 3 (0–10). According to blind evaluation, hair appearance at the 1-month FU was better in 63% and much better in 9% of the patients compared with the baseline. No adverse reactions were reported.</p>\u0000 <p><b>Conclusions:</b> The results of this study corroborate the effectiveness of treatment with nonablative Er:YAG laser therapy for AGA. Six biweekly sessions resulted in general patient satisfaction and visible improvement in hair appearance.</p>\u0000 </div>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2025 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/2419414","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of Night Peeling With Azelaic Acid on Mature Facial Skin Parameters After 28 Days of Use: Preliminary Report 杜鹃花酸夜间脱皮对使用28天后成熟面部皮肤参数的影响:初步报告
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-05-30 DOI: 10.1155/dth/9941546
M. Drozdova-Statkevičienė, R. Rauluševičienė

The aim of this study was to determine the effect of night peeling with azelaic acid (AA) on the parameters of mature facial skin after 28 days of use. The sample consisted of 28 participants (six participants did not complete the study for reasons unrelated to cosmetic intolerance), aged 40–68 years old, including both men and women, with dry and/or normal skin types, closed comedones, and visible signs of aging. The study lasted 28 days, during which all participants were evaluated before and after the treatment with the night peeling containing AA. The results showed that not all parameters changed significantly. Significant changes was observed in the skin moisture level (increased by 4%), skin elasticity (improved by 11%), and wrinkle length (reduced by 4%). In addition, it reduced wrinkle count by an average of 15%, wrinkle volume by an average of 8%, and wrinkle area by an average of 5%. These findings indicate a successful response to the night peeling treatment with AA. However, the study was relatively small in size and could be extended to include more subjects and investigate the use of the product over a longer period of time.

本研究旨在探讨杜鹃花酸夜间脱皮对面部成熟皮肤使用28天后各项参数的影响。样本包括28名参与者(6名参与者由于与化妆品不耐受无关的原因没有完成研究),年龄在40-68岁之间,包括男性和女性,皮肤类型干燥和/或正常,粉刺闭合,并有明显的衰老迹象。研究持续28天,在此期间,所有参与者在使用含AA的夜间脱皮治疗前后进行评估。结果表明,并非所有参数都发生了显著变化。在皮肤水分水平(增加了4%)、皮肤弹性(改善了11%)和皱纹长度(减少了4%)方面观察到显著变化。此外,它还能平均减少15%的皱纹计数,平均减少8%的皱纹体积,平均减少5%的皱纹面积。这些发现表明AA对夜间脱皮治疗有成功的反应。然而,这项研究的规模相对较小,可以扩大到包括更多的受试者,并在更长的时间内调查产品的使用情况。
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引用次数: 0
Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study 通过对银屑病、银屑病关节炎和强直性脊柱炎患者9年的临床研究评估Secukinumab的长期真实世界安全性:来自一项多中心回顾性研究的结果
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-05-24 DOI: 10.1155/dth/9618241
Elena Ippoliti, Gennaro Marco Falco, Tiago Torres, Eleonora De Luca, Clara De Simone, Giacomo Caldarola, Augusta Ortolan, Arianna Guaita, Andrea Chiricozzi, Giusy Peluso, Ketty Peris, Maria Antonietta D’Agostino

Secukinumab is a biologic agent known for its durable efficacy in chronic plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Monitoring the safety of secukinumab is a priority to ensure its long-term usage. We aimed to provide an extended safety assessment of secukinumab treatment in a real-world setting. This bicentric observational study enrolled 332 patients with PsO, PsA and AS who received subcutaneous injections of secukinumab for up to 9 years. Adverse events (AEs) were reported annually as exposure-adjusted incidence rates (EAIRs) per 100 patient-years (pt-y). The total secukinumab exposure was 1129 pt-y. The retention rate was 73%, with 16 (4.8%) of patients discontinuing due to AEs. Despite most AEs being reported within the first 2 years, their incidence was low and decreased over time. The EAIR of any AEs was the highest in the initial 6 months (32.72/100 pt-y), followed by year 1 (7.62/100 pt-y), and year 2 of treatment (3.01/100 pt-y). Common AEs included respiratory and urinary tract infections, candidiasis, and diarrhoea. Secukinumab showed sustained safety over an extended 9-year treatment period, supporting its use for the long-term management of these immune-inflammatory disorders.

Secukinumab是一种生物制剂,以其对慢性斑块型银屑病(PsO),银屑病关节炎(PsA)和强直性脊柱炎(AS)的持久疗效而闻名。监测secukinumab的安全性是确保其长期使用的首要任务。我们的目标是在现实环境中对secukinumab治疗进行扩展的安全性评估。这项双中心观察性研究纳入了332例PsO、PsA和AS患者,这些患者接受皮下注射secukinumab长达9年。不良事件(ae)每年以每100患者年(pt-y)的暴露调整发生率(eair)报告。总暴露量为1129pt -y。保留率为73%,16例(4.8%)患者因不良反应而停止治疗。尽管大多数ae是在头2年内报告的,但它们的发生率很低,并随着时间的推移而下降。所有ae的EAIR在前6个月最高(32.72/100 pt-y),其次是治疗第1年(7.62/100 pt-y)和第2年(3.01/100 pt-y)。常见的ae包括呼吸道和尿路感染、念珠菌病和腹泻。Secukinumab在延长的9年治疗期内显示出持续的安全性,支持其用于这些免疫炎性疾病的长期治疗。
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引用次数: 0
A Randomized Controlled Study of the Efficacy of a Topical Antifungal, Antimicrobial, Anti-Inflammatory, and Antiseborrheic Cream in Treating Mild to Moderate Facial Seborrheic Dermatitis 局部抗真菌、抗菌、抗炎和抗脂溢性乳膏治疗轻度至中度面部脂溢性皮炎疗效的随机对照研究
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-05-15 DOI: 10.1155/dth/8887280
Kridipop Charoenchaipiyakul, Patcharapong Rujirawan, Nopadon Noppakun, Yuda Chongpison, Chanat Kumtornrut

Seborrheic dermatitis (SD) presents treatment challenges due to its complex pathogenesis. A nonsteroidal cream (NSC) with antifungal, antimicrobial, anti-inflammatory, and antiseborrheic properties containing piloctone olamine, biosaccharide gum-2, stearyl glycyrrhetinate, and zinc PCA has shown promise in previous studies with the design that lacked control groups and demographic diversity. To validate its efficacy, this randomized, assessor-blinded, controlled trial included 50 Thai subjects with mild-to-moderate facial SD. Participants were randomized 1:1 to apply either NSC or a hydrophilic cream (control) twice daily for 8 weeks. Assessments at week (W) 0, 4, 8, and 12 (4 weeks posttreatment) included severity scores (mSDASI), Investigator Global Assessment (IGA), pruritus, and skin biophysics (erythema index, hydration, TEWL, and sebum levels). The use of triamcinolone acetonide 0.02% cream as rescue medication was recorded. Both NSC (n = 25) and control (n = 25) groups showed clinical improvement from W4, peaking at W8 and continuing to W12. The NSC group’s mSDASI significantly differed from controls at W8 (p = 0.043). The proportion of subjects achieving successful IGA (> 80% improvement) was significantly higher in the NSC group at W8 (44% vs. 16%, p = 0.048). NSC also significantly reduced erythema index at all visits and sebum levels at W4, with lower trends toward pruritus and rescue medication use during treatment. No adverse effects were reported. Overall, NSC demonstrated positive therapeutic effects for mild to moderate facial SD in Southeast Asians, highlighting its potential as a treatment option.

Trail Registration: Thai Clinical Trials Registry: TCTR20230811003

脂溢性皮炎(SD)由于其复杂的发病机制,提出了治疗挑战。一种非甾体乳膏(NSC)具有抗真菌、抗菌、抗炎和抗脂溢性质的特性,其中含有匹洛酮olamine、生物糖gum-2、硬脂酰甘草酸酯和锌PCA,在先前缺乏对照组和人口多样性的研究中显示出前景。为了验证其有效性,这项随机、评估盲法、对照试验纳入了50名患有轻度至中度面部SD的泰国受试者。参与者按1:1随机分配,每天两次使用NSC或亲水性乳霜(对照组),持续8周。治疗后第0、4、8和12周(治疗后4周)的评估包括严重程度评分(mssdasi)、研究者总体评估(IGA)、瘙痒和皮肤生物物理(红斑指数、水合作用、TEWL和皮脂水平)。记录使用0.02%曲安奈德乳膏作为抢救用药。NSC组(n = 25)和对照组(n = 25)从W4开始临床改善,在W8达到顶峰,并持续到W12。NSC组的mssdasi在W8时与对照组有显著差异(p = 0.043)。成功完成IGA的受试者比例(>;80%的改善)在W8时NSC组明显更高(44% vs. 16%, p = 0.048)。NSC还显著降低了所有就诊时的红斑指数和W4时的皮脂水平,治疗期间出现瘙痒和抢救用药的趋势较低。无不良反应报告。总的来说,NSC对东南亚轻度至中度面部SD有积极的治疗效果,突出了其作为治疗选择的潜力。试验注册:泰国临床试验注册:TCTR20230811003
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引用次数: 0
Examining Recruitment and Retention Strategies in Hidradenitis Suppurativa Clinical Trials: A Cross-Sectional Study 研究化脓性汗腺炎临床试验的招募和保留策略:一项横断面研究
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-05-07 DOI: 10.1155/dth/9974685
Jeanie Marchbanks, Eddy Bagaruka, Merhawit Ghebrehiwet, Andrew Wilson, Josh Autaubo, Payton Clark, Chase Pitchford, Alicia Ito Ford, Matt Vassar

Background: To ensure equitable and successful treatment outcomes for hidradenitis suppurativa (HS), the recruitment and retention of diverse participants in clinical trials is critical. However, current approaches may neglect under-represented populations, potentially limiting the result application.

Objective: This study aimed to evaluate existing recruitment and retention strategies in HS trials, identifying gaps and proposing methods to improve inclusivity and participant retention.

Methods: We conducted a cross-sectional analysis of 36 HS clinical trials from January 2018 to December 2023, following PRISMA guidelines. Trial characteristics and specific recruitment/retention approaches were assessed through data extraction and Stata 18 SE statistical analysis.

Results: Of the 36 trials, 18/36 (50.0%) reported use of specific retention strategies, while 1/36 (2.8%) of the trials documented recruitment strategies for under-represented groups. Diversity goals were also unreported in recruitment processes. Most trials (63.9%) received industry funding, and therapeutic intervention was the most common treatment type (97.2%).

Limitations: Only articles from 2018 to 2023 were analyzed, limiting the finding generalizability over broader timeframes.

Conclusion: This study reveals significant gaps in recruitment/retention strategies within HS trials, which is important for enhancing result relevance and inclusivity, particularly among historically marginalized populations. Implementing specific approaches and innovative methods is critical for improving HS treatment efficacy and reducing health inequities.

背景:为了确保化脓性汗腺炎(HS)的公平和成功的治疗结果,招募和保留不同的临床试验参与者是至关重要的。然而,目前的方法可能忽略了代表性不足的人群,潜在地限制了结果的应用。目的:本研究旨在评估HS试验中现有的招募和保留策略,找出差距,并提出提高包容性和参与者保留的方法。方法:我们按照PRISMA指南,对2018年1月至2023年12月的36项HS临床试验进行了横断面分析。通过数据提取和Stata 18 SE统计分析评估试验特征和具体的招募/保留方法。结果:在36项试验中,18/36(50.0%)的试验报告使用了特定的保留策略,而1/36(2.8%)的试验记录了代表性不足群体的招募策略。在招聘过程中也没有报告多样性目标。大多数试验(63.9%)获得行业资助,治疗干预是最常见的治疗方式(97.2%)。局限性:仅分析了2018年至2023年的文章,限制了研究结果在更广泛时间范围内的普遍性。结论:本研究揭示了HS试验中招募/保留策略的显著差距,这对于提高结果的相关性和包容性非常重要,特别是在历史上被边缘化的人群中。实施具体办法和创新方法对于提高卫生保健治疗效果和减少卫生不公平现象至关重要。
{"title":"Examining Recruitment and Retention Strategies in Hidradenitis Suppurativa Clinical Trials: A Cross-Sectional Study","authors":"Jeanie Marchbanks,&nbsp;Eddy Bagaruka,&nbsp;Merhawit Ghebrehiwet,&nbsp;Andrew Wilson,&nbsp;Josh Autaubo,&nbsp;Payton Clark,&nbsp;Chase Pitchford,&nbsp;Alicia Ito Ford,&nbsp;Matt Vassar","doi":"10.1155/dth/9974685","DOIUrl":"https://doi.org/10.1155/dth/9974685","url":null,"abstract":"<div>\u0000 <p><b>Background:</b> To ensure equitable and successful treatment outcomes for hidradenitis suppurativa (HS), the recruitment and retention of diverse participants in clinical trials is critical. However, current approaches may neglect under-represented populations, potentially limiting the result application.</p>\u0000 <p><b>Objective:</b> This study aimed to evaluate existing recruitment and retention strategies in HS trials, identifying gaps and proposing methods to improve inclusivity and participant retention.</p>\u0000 <p><b>Methods:</b> We conducted a cross-sectional analysis of 36 HS clinical trials from January 2018 to December 2023, following PRISMA guidelines. Trial characteristics and specific recruitment/retention approaches were assessed through data extraction and Stata 18 SE statistical analysis.</p>\u0000 <p><b>Results:</b> Of the 36 trials, 18/36 (50.0%) reported use of specific retention strategies, while 1/36 (2.8%) of the trials documented recruitment strategies for under-represented groups. Diversity goals were also unreported in recruitment processes. Most trials (63.9%) received industry funding, and therapeutic intervention was the most common treatment type (97.2%).</p>\u0000 <p><b>Limitations:</b> Only articles from 2018 to 2023 were analyzed, limiting the finding generalizability over broader timeframes.</p>\u0000 <p><b>Conclusion:</b> This study reveals significant gaps in recruitment/retention strategies within HS trials, which is important for enhancing result relevance and inclusivity, particularly among historically marginalized populations. Implementing specific approaches and innovative methods is critical for improving HS treatment efficacy and reducing health inequities.</p>\u0000 </div>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2025 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/9974685","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143914450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comprehensive Analysis of the Chemokine/Cytokine Profiles in Advanced Mycosis Fungoides and Atopic Dermatitis 晚期蕈样真菌病和特应性皮炎趋化因子/细胞因子谱的综合分析
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-05-03 DOI: 10.1155/dth/6603966
Manami Takahashi-Watanabe, Taku Fujimura, Emi Yamazaki, Ryo Amagai, Kenta Oka, Yumi Kambayashi, Maki Ozawa, Tomoko Chiba, Mayuko Onodera-Amagai, Toshiya Takahashi, Yoshihide Asano

Mycosis fungoides (MF) is an indolent form of cutaneous T-cell lymphoma. Its early lesions are important to be distinguished from atopic dermatitis (AD) because of their similar immune microenvironment. We have previously demonstrated that several chemokines are involved in the pathogenesis of advanced MF. Therefore, we sought to comprehensively analyze the changes in the immune environment during the advanced phase of MF by focusing on serum cytokines and chemokines and to identify potential biomarkers for the early detection of the transition to the advanced phase of MF. Sera from 11 cases of advanced-stage MF, 16 cases of mild AD (median EASI score = 5.75), 16 cases of severe AD (median EASI score = 28.1), and 21 healthy volunteers were analyzed using the Bio-Plex 40 multiplex immunoassay system. The results revealed significant increases in immunosuppressive macrophage-related factors (IL-4, MIF, CCL3) in MF patients compared to those with AD and healthy controls. In contrast, IL-2, CCL1, CCL7, CCL21, CCL25, and CCL26 were significantly increased in severe AD patients compared to MF patients and healthy controls. Our findings suggest that several chemokines and cytokines contribute to an immunosuppressive environment favorable for tumor growth, distinguishing MF from AD. Moreover, T-cell proliferation and migration factors, which are mainly involved in maintaining inflammation, are elevated in severe AD compared to MF. In addition to elucidating the differences in the pathogenesis of these diseases, these factors may be important in the differential diagnosis of early MF and AD. Further studies are warranted to confirm these findings.

蕈样真菌病(MF)是皮肤t细胞淋巴瘤的一种惰性形式。由于其免疫微环境相似,其早期病变与特应性皮炎(AD)的区别非常重要。我们之前已经证明了几种趋化因子参与晚期MF的发病机制。因此,我们试图通过关注血清细胞因子和趋化因子来全面分析MF晚期免疫环境的变化,并确定早期检测过渡到MF晚期的潜在生物标志物。采用Bio-Plex 40多重免疫分析系统对11例晚期MF、16例轻度AD (EASI评分中位数为5.75)、16例重度AD (EASI评分中位数为28.1)和21例健康志愿者的血清进行分析。结果显示,与AD患者和健康对照相比,MF患者的免疫抑制巨噬细胞相关因子(IL-4、MIF、CCL3)显著增加。相比之下,与MF患者和健康对照相比,严重AD患者的IL-2、CCL1、CCL7、CCL21、CCL25和CCL26显著升高。我们的研究结果表明,几种趋化因子和细胞因子有助于形成有利于肿瘤生长的免疫抑制环境,从而将MF与AD区分开来。此外,与MF相比,严重AD中主要参与维持炎症的t细胞增殖和迁移因子升高。除了阐明这些疾病的发病机制差异外,这些因素可能对早期MF和AD的鉴别诊断很重要。需要进一步的研究来证实这些发现。
{"title":"Comprehensive Analysis of the Chemokine/Cytokine Profiles in Advanced Mycosis Fungoides and Atopic Dermatitis","authors":"Manami Takahashi-Watanabe,&nbsp;Taku Fujimura,&nbsp;Emi Yamazaki,&nbsp;Ryo Amagai,&nbsp;Kenta Oka,&nbsp;Yumi Kambayashi,&nbsp;Maki Ozawa,&nbsp;Tomoko Chiba,&nbsp;Mayuko Onodera-Amagai,&nbsp;Toshiya Takahashi,&nbsp;Yoshihide Asano","doi":"10.1155/dth/6603966","DOIUrl":"https://doi.org/10.1155/dth/6603966","url":null,"abstract":"<div>\u0000 <p>Mycosis fungoides (MF) is an indolent form of cutaneous T-cell lymphoma. Its early lesions are important to be distinguished from atopic dermatitis (AD) because of their similar immune microenvironment. We have previously demonstrated that several chemokines are involved in the pathogenesis of advanced MF. Therefore, we sought to comprehensively analyze the changes in the immune environment during the advanced phase of MF by focusing on serum cytokines and chemokines and to identify potential biomarkers for the early detection of the transition to the advanced phase of MF. Sera from 11 cases of advanced-stage MF, 16 cases of mild AD (median EASI score = 5.75), 16 cases of severe AD (median EASI score = 28.1), and 21 healthy volunteers were analyzed using the Bio-Plex 40 multiplex immunoassay system. The results revealed significant increases in immunosuppressive macrophage-related factors (IL-4, MIF, CCL3) in MF patients compared to those with AD and healthy controls. In contrast, IL-2, CCL1, CCL7, CCL21, CCL25, and CCL26 were significantly increased in severe AD patients compared to MF patients and healthy controls. Our findings suggest that several chemokines and cytokines contribute to an immunosuppressive environment favorable for tumor growth, distinguishing MF from AD. Moreover, T-cell proliferation and migration factors, which are mainly involved in maintaining inflammation, are elevated in severe AD compared to MF. In addition to elucidating the differences in the pathogenesis of these diseases, these factors may be important in the differential diagnosis of early MF and AD. Further studies are warranted to confirm these findings.</p>\u0000 </div>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2025 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/6603966","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143900921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is Safety Profile of Apremilast in Elderly Patients Same With That in Young and Middle-Aged Patients? A Real-World Disproportionality Analysis of the FDA Adverse Event Reporting System 阿普米司特在老年患者中的安全性与中青年患者相同吗?FDA不良事件报告系统的实际歧化分析
IF 3.7 4区 医学 Q1 DERMATOLOGY Pub Date : 2025-04-25 DOI: 10.1155/dth/8851158
Chenyang Yu, Jinxin Qi, Wei Yan, Xian Jiang

Background and Objective: Elderly individuals face heightened risks of infections, thrombosis, cardiovascular issues, and neoplasms, necessitating increased vigilance regarding adverse drug events (ADEs). The safety of apremilast in elderly patients has not been adequately explored in clinical trials. This study was to evaluate the safety profile of apremilast in young and middle-aged patients and elderly patients separately, through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods: Reports in the FAERS from the third quarter of 2014 to the second quarter of 2023 were collected and analyzed. Disproportionality analyses (the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms) were employed to quantify the ADE signals of apremilast in the age groups of 18–65 years and over 65 years.

Results: After data cleaning, a total of 54,926 and 14,156 ADE reports were retrieved, with 66 and 61 ADE signals identified in young and middle-aged patients and in elderly patients, respectively. Several unexpected ADE signals not listed in the drug labeling information were detected, including pericarditis, increased cholesterol levels, liver injury, postoperative thrombosis, serum calcium, and parathyroid abnormalities. Furthermore, weight loss, psychiatric abnormalities, and infections in particular sites (ear, bursa mucosa, and central nervous system) were more significant in elderly patients.

Conclusions: The study indicated several unexpected ADEs through disproportionality analysis and highlighted unique safety features in the elderly group. These findings may assist clinicians in managing psoriasis with apremilast.

背景和目的:老年人面临感染、血栓形成、心血管问题和肿瘤的高风险,需要提高对药物不良事件(ADEs)的警惕。阿普米司特在老年患者中的安全性尚未在临床试验中得到充分的探讨。本研究通过美国食品和药物管理局不良事件报告系统(FAERS)的数据挖掘,分别评价阿普米司特在中青年和老年患者中的安全性。方法:收集2014年第三季度至2023年第二季度FAERS报告并进行分析。采用歧化分析(报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽玛泊松收缩器(MGPS)算法)量化18-65岁和65岁以上年龄组阿普雷米拉斯特ADE信号。结果:经过数据清理,共检索到54,926份ADE报告和14,156份ADE报告,分别在中青年患者和老年患者中发现了66份和61份ADE信号。检测到一些未在药物标签信息中列出的意外ADE信号,包括心包炎、胆固醇水平升高、肝损伤、术后血栓形成、血清钙和甲状旁腺异常。此外,体重下降、精神异常和特定部位(耳部、滑囊粘膜和中枢神经系统)感染在老年患者中更为显著。结论:通过歧化分析,本研究发现了一些意想不到的不良事件,并突出了老年人群独特的安全性特征。这些发现可能有助于临床医生用阿普米司特治疗牛皮癣。
{"title":"Is Safety Profile of Apremilast in Elderly Patients Same With That in Young and Middle-Aged Patients? A Real-World Disproportionality Analysis of the FDA Adverse Event Reporting System","authors":"Chenyang Yu,&nbsp;Jinxin Qi,&nbsp;Wei Yan,&nbsp;Xian Jiang","doi":"10.1155/dth/8851158","DOIUrl":"https://doi.org/10.1155/dth/8851158","url":null,"abstract":"<div>\u0000 <p><b>Background and Objective:</b> Elderly individuals face heightened risks of infections, thrombosis, cardiovascular issues, and neoplasms, necessitating increased vigilance regarding adverse drug events (ADEs). The safety of apremilast in elderly patients has not been adequately explored in clinical trials. This study was to evaluate the safety profile of apremilast in young and middle-aged patients and elderly patients separately, through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).</p>\u0000 <p><b>Methods:</b> Reports in the FAERS from the third quarter of 2014 to the second quarter of 2023 were collected and analyzed. Disproportionality analyses (the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms) were employed to quantify the ADE signals of apremilast in the age groups of 18–65 years and over 65 years.</p>\u0000 <p><b>Results:</b> After data cleaning, a total of 54,926 and 14,156 ADE reports were retrieved, with 66 and 61 ADE signals identified in young and middle-aged patients and in elderly patients, respectively. Several unexpected ADE signals not listed in the drug labeling information were detected, including pericarditis, increased cholesterol levels, liver injury, postoperative thrombosis, serum calcium, and parathyroid abnormalities. Furthermore, weight loss, psychiatric abnormalities, and infections in particular sites (ear, bursa mucosa, and central nervous system) were more significant in elderly patients.</p>\u0000 <p><b>Conclusions:</b> The study indicated several unexpected ADEs through disproportionality analysis and highlighted unique safety features in the elderly group. These findings may assist clinicians in managing psoriasis with apremilast.</p>\u0000 </div>","PeriodicalId":11045,"journal":{"name":"Dermatologic Therapy","volume":"2025 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/dth/8851158","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143875627","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Dermatologic Therapy
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