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Methodologic considerations in evaluating early clinical outcomes of GT20029 for androgenetic alopecia. 评价GT20029治疗雄激素性脱发早期临床结果的方法学考虑。
IF 3.9 Pub Date : 2026-12-01 Epub Date: 2026-01-15 DOI: 10.1080/09546634.2026.2616552
Samuel Tringali
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引用次数: 0
Clinical outcomes of intense pulsed light combined with non-crosslinked sodium hyaluronate, tranexamic acid, and vitamin C mesotherapy for facial photoaging: a retrospective study. 强脉冲光联合非交联透明质酸钠、氨甲环酸和维生素C治疗面部光老化的临床结果:一项回顾性研究。
IF 3.9 Pub Date : 2026-12-01 Epub Date: 2026-01-05 DOI: 10.1080/09546634.2025.2609454
Houhuang Qiu, Jialu Xu, Xixin Wu, Yutong Wu, Xi Chen, Ping Zhong, Fangfang Wang, Qiusheng Lin, Fei Li, Tianhua Xu

Background: Facial photoaging involves structural and functional deterioration across multiple skin layers. Single-modality treatments rarely address pigmentary, vascular, and dermal matrix changes concurrently. Intense pulsed light (IPL) is widely used for the treatment of dyschromia and vascular lesions. Mesotherapy incorporating non-crosslinked sodium hyaluronate (NCSH), tranexamic acid (TXA), and vitamin C (VC) has been introduced to improve skin hydration and related dermal parameters. The present study assessed the efficacy and safety of combining these modalities for facial rejuvenation.

Methods: Eighty-four patients underwent three sessions of IPL with mesotherapy. Standardized VISIA imaging was conducted before each treatment (T0, T1, T2) and at 1-2 months (T3) and 3-6 months (T4) post-treatment. Efficacy was assessed using the Modified Fitzpatrick Wrinkle Scale (MFWS) and Global Aesthetic Improvement Scale (GAIS); adverse events and satisfaction were recorded.

Results: All six VISIA parameters and MFWS scores improved significantly (p <0.001), peaking at T3 with mild non-significant rebound at T4. GAIS and satisfaction assessments confirmed consistent aesthetic improvement. No severe adverse events occurred; transient burning, papular reactions, and erythema were most common. The overall satisfaction rate was 82.15%.

Conclusions: IPL combined with NCSH/TXA/VC mesotherapy provided safe, effective, and well-tolerated improvement in facial photoaging, representing a promising multimodal rejuvenation approach.

背景:面部光老化涉及多个皮肤层的结构和功能退化。单模态治疗很少同时处理色素、血管和真皮基质的改变。强脉冲光(IPL)广泛用于治疗色差和血管病变。引入非交联透明质酸钠(NCSH)、氨甲环酸(TXA)和维生素C (VC)的美索疗法可以改善皮肤水合作用和相关皮肤参数。本研究评估了结合这些方式进行面部年轻化的有效性和安全性。方法:84例患者分别进行了3次IPL和化疗。在每次治疗前(T0、T1、T2)以及治疗后1-2个月(T3)和3-6个月(T4)进行标准化VISIA成像。采用改良Fitzpatrick皱纹量表(MFWS)和全球美容改善量表(GAIS)评估疗效;记录不良事件和满意度。结果:所有6项VISIA参数和MFWS评分均显著改善(p 0.001), T3达到峰值,T4轻度无显著反弹。GAIS和满意度评估证实了持续的美学改善。未发生严重不良事件;短暂的灼烧、丘疹反应和红斑最为常见。总体满意度为82.15%。结论:IPL联合NCSH/TXA/VC化疗可安全、有效且耐受性良好地改善面部光老化,是一种有前途的多模式年轻化方法。
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引用次数: 0
From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases. 从信号到策略:FAERS中dupilumab相关酒痤疮的歧化分析,并总结了已报道的临床病例。
IF 3.9 Pub Date : 2026-12-01 Epub Date: 2026-01-05 DOI: 10.1080/09546634.2025.2605426
Sitong Li, Jiacheng Lin, Xuefan Yang, Xinlan Qiu, Dandan Ruan, Jiaqi Li, Xiang Chen, Xiaohui Mo, Qiang Ju

Purpose: Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.

Materials and methods: We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.

Results: A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.

Conclusions: DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.

目的:新出现的证据表明酒糟是杜匹单抗治疗期间可识别的不良事件。本研究旨在利用药物警戒数据调查杜匹单抗与酒渣鼻之间的潜在关联,并通过对已报道病例的回顾来表征杜匹单抗相关酒渣鼻(DAR)的临床特征。材料和方法:我们利用FDA不良事件报告系统(FAERS)数据库(2017-2024),采用报告优势比(ROR)、比例报告比(PRR)、信息成分(IC)和经验贝叶斯几何平均(EBGM)四种方法识别歧化信号。为了将这些发现置于背景中,我们对8份出版物进行了集中的叙述性回顾,其中包括10例具有可提取个人数据的DAR病例。结果:在所有四种方法中都发现了显著的歧化信号(ROR 3.873; PRR 3.872; IC 1.865, IC025 1.653; EBGM 3.642),报告主要发生在成人和女性中。在病例回顾中,出现了一致的表型:丘疹疱持续的面部中心性红斑伴频繁灼烧;面部优势,偶尔延伸至颈部、头皮或躯干上部;频繁通过刮痧、KOH或活体成像检测蠕形螨;偶见肉芽肿组织学。发病时间约为2周到21个月,包括1例停药后病例。大多数患者通过酒渣鼻定向治疗(局部伊维菌素或甲硝唑;抗炎剂量强力霉素)改善。然而,在一个亚群中,解除挑战或重新挑战模式以及需要延长剂量间隔、暂时中断或切换生物(例如,lebrikizumab, upadacitinib)支持报告水平的药物相关模式。结论:DAR与杜匹单抗相关的头颈部皮炎不同,后者是湿疹,通常对抗真菌药物或钙调磷酸酶抑制剂有反应。虽然歧化信号表明相关性,而不是发病率或因果关系,并受到报告偏倚的影响,临床医生应该意识到这种潜在的不良事件,以确保适当的管理。
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引用次数: 0
Dose-dependent effectiveness and patient-reported outcomes with JAK1 inhibitors in atopic dermatitis: a 36-week multicenter real-world cohort. JAK1抑制剂治疗特应性皮炎的剂量依赖性疗效和患者报告的结果:一项为期36周的多中心现实世界队列研究
IF 3.9 Pub Date : 2026-12-01 Epub Date: 2026-01-08 DOI: 10.1080/09546634.2025.2605834
Abdullah Demirbaş, Mustafa Esen, Esin Diremsizoglu, Gözde Ulutaş Demirbaş

Background: Dose-stratified real-world data for JAK1 inhibitors in AD are limited.

Objective: To compare effectiveness and safety of standard vs high doses of abrocitinib and upadacitinib in routine care.

Methods: Multicenter, retrospective cohort study. The primary endpoint was Week-12 achievement of Eczema Area and Severity Index (EASI)-75. Secondary outcomes included patient-reported improvements at Minimal Clinically Important Difference (MCID) thresholds, Minimal Disease Activity (MDA) at Week 36, time-to-EASI-75, and treatment-emergent adverse events(TEAE).

Results: A total of 124 patients were analyzed (abrocitinib 100 mg, n = 28; abrocitinib 200 mg, n = 32; upadacitinib 15 mg, n = 30; upadacitinib 30 mg, n = 34). At Week 12, EASI-75 was achieved in 20/32 (62.5%) versus 10/28 (35.7%) for abrocitinib (OR 2.94, 95% CI 1.06-8.15; p = 0.036) and in 22/34 (64.7%) versus 14/30 (46.7%) for upadacitinib (OR 2.92, 95% CI 1.16-7.38; p = 0.021), favoring the higher-dose regimens. Itch improvement was more frequent with higher doses. By Week 36, full minimal disease activity was observed in 30.2% of patients receiving abrocitinib 200 mg and 26.7% receiving upadacitinib 30 mg, compared with 18.4% and 20.0% in the lower-dose groups. Kaplan-Meier analysis showed faster responses with high doses (median 12 vs 36 weeks; log-rank p < 0.01). Safety was comparable across groups.

Conclusion: High-dose JAK1 regimens achieve faster, numerically greater disease control without short-term safety tradeoffs, supporting escalation in suboptimal responders.

背景:JAK1抑制剂治疗AD的剂量分层真实数据有限。目的:比较常规护理中标准剂量与大剂量阿布替尼和更新他替尼的有效性和安全性。方法:多中心、回顾性队列研究。主要终点是第12周达到湿疹面积和严重程度指数(EASI)-75。次要结局包括患者报告的最小临床重要差异(MCID)阈值的改善,第36周的最小疾病活动度(MDA),到easi -75的时间和治疗出现的不良事件(TEAE)。结果:共分析124例患者(abrocitinib 100 mg, n = 28; abrocitinib 200 mg, n = 32; upadacitinib 15 mg, n = 30; upadacitinib 30 mg, n = 34)。在第12周,EASI-75在阿布替尼的20/32(62.5%)和10/28(35.7%)中达到(OR 2.94, 95% CI 1.06-8.15; p = 0.036),在upadacitinib的22/34(64.7%)和14/30(46.7%)中达到(OR 2.92, 95% CI 1.16-7.38; p = 0.021),更倾向于高剂量方案。剂量越高,瘙痒改善越频繁。到第36周,30.2%接受阿布西替尼200mg的患者和26.7%接受upadacitinib 30mg的患者观察到完全最小的疾病活动,而低剂量组为18.4%和20.0%。Kaplan-Meier分析显示,高剂量治疗反应更快(中位数为12周vs 36周;logrank p)。结论:高剂量JAK1治疗方案在没有短期安全性权衡的情况下实现更快、更大的疾病控制,支持次优反应的升级。
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引用次数: 0
Expanding the therapeutic horizons of spesolimab: a review of off-label applications for inflammatory skin diseases. 扩大司匹利单抗的治疗范围:对炎症性皮肤病说明书外应用的回顾。
Pub Date : 2025-12-01 Epub Date: 2025-02-16 DOI: 10.1080/09546634.2025.2460582
Hanlin Zhang, Jia Zhou, Keyun Tang, Xinyi Zhang, Hongzhong Jin

Purpose: This review aims to outline the crucial role of IL-36 signaling in inflammatory skin diseases and summarize the therapeutic potential of spesolimab. Our goal is to provide insights into the off-label applications of spesolimab and future directions for its use in treating other challenging skin diseases.

Materials and methods: We conducted a comprehensive literature search across PubMed, Embase, Web of Science, MEDLINE, Scopus, and the Cochrane Library to identify relevant studies. For RCTs, we additionally searched the ClinicalTrials.gov database.

Results: In this review, we examine its off-label applications for conditions such as palmoplantar pustulosis, acrodermatitis continua of Hallopeau, hidradenitis suppurativa, pyoderma gangrenosum, and acute generalized exanthematous pustulosis. This review also explores the role of IL-36 in the pathophysiology of these disorders and discusses how spesolimab may address the limitations of current therapies for refractory cases. Randomized controlled trials and case reports are summarized to highlight the efficacy and tolerability of spesolimab across various inflammatory skin conditions. We highlight the challenges presented by the absence of standardized treatment guidelines and the need for larger clinical trials.

Conclusions: This review underscores the potential of spesolimab to enhance treatment strategies for inflammatory skin diseases.

目的:本文旨在概述IL-36信号在炎症性皮肤病中的重要作用,并总结司匹利单抗的治疗潜力。我们的目标是为spesolimab的超说明书应用提供见解,并为其在治疗其他挑战性皮肤疾病中的应用提供未来的方向。材料和方法:我们在PubMed、Embase、Web of Science、MEDLINE、Scopus和Cochrane图书馆进行了全面的文献检索,以确定相关研究。对于随机对照试验,我们还检索了ClinicalTrials.gov数据库。结果:在这篇综述中,我们研究了它在治疗掌足底脓疱病、持续的埃洛珀肢端皮炎、化脓性汗腺炎、坏疽性脓皮病和急性全发性脓疱病等疾病中的适应症外应用。这篇综述还探讨了IL-36在这些疾病的病理生理中的作用,并讨论了spesolimab如何解决当前治疗难治性病例的局限性。本文总结了随机对照试验和病例报告,以强调司匹利单抗在各种炎症性皮肤状况下的疗效和耐受性。我们强调了缺乏标准化治疗指南和需要更大规模的临床试验所带来的挑战。结论:本综述强调了司匹利单抗增强炎性皮肤病治疗策略的潜力。
{"title":"Expanding the therapeutic horizons of spesolimab: a review of off-label applications for inflammatory skin diseases.","authors":"Hanlin Zhang, Jia Zhou, Keyun Tang, Xinyi Zhang, Hongzhong Jin","doi":"10.1080/09546634.2025.2460582","DOIUrl":"10.1080/09546634.2025.2460582","url":null,"abstract":"<p><strong>Purpose: </strong>This review aims to outline the crucial role of IL-36 signaling in inflammatory skin diseases and summarize the therapeutic potential of spesolimab. Our goal is to provide insights into the off-label applications of spesolimab and future directions for its use in treating other challenging skin diseases.</p><p><strong>Materials and methods: </strong>We conducted a comprehensive literature search across PubMed, Embase, Web of Science, MEDLINE, Scopus, and the Cochrane Library to identify relevant studies. For RCTs, we additionally searched the ClinicalTrials.gov database.</p><p><strong>Results: </strong>In this review, we examine its off-label applications for conditions such as palmoplantar pustulosis, acrodermatitis continua of Hallopeau, hidradenitis suppurativa, pyoderma gangrenosum, and acute generalized exanthematous pustulosis. This review also explores the role of IL-36 in the pathophysiology of these disorders and discusses how spesolimab may address the limitations of current therapies for refractory cases. Randomized controlled trials and case reports are summarized to highlight the efficacy and tolerability of spesolimab across various inflammatory skin conditions. We highlight the challenges presented by the absence of standardized treatment guidelines and the need for larger clinical trials.</p><p><strong>Conclusions: </strong>This review underscores the potential of spesolimab to enhance treatment strategies for inflammatory skin diseases.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2460582"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143434849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Whether the transient hair shedding phase exist after minoxidil treatment and does it predict treatment efficacy? A retrospective study in androgenetic alopecia patients. 米诺地尔治疗后是否存在短暂的脱毛期,是否能预测治疗效果?雄激素性脱发患者的回顾性研究。
Pub Date : 2025-12-01 Epub Date: 2025-03-23 DOI: 10.1080/09546634.2025.2480739
Lingbo Bi, Haili Kan, Jing Wang, Yunbu Ding, Yuanbo Huang, Chaofan Wang, Yimei Du, Changpei Lu, Min Zhao, Weiling Sun, Tong Su, Weixin Fan

Purpose: Minoxidil is a routinely used drug in treating multiple hair disorders. This study aimed to investigate the facticity of the temporal increase in the hair shedding amount after topical use of minoxidil.

Materials and methods: We selected 49 patients who used 2% or 5% minoxidil topically to treat androgenetic alopecia for 24 weeks. The amount of hair shedding was recorded every four weeks before and after the treatment. The BASP classification and trichoscopy test results were also recorded before and after the treatment. The relative amount of hair shedding (RAHS) was defined as the recorded number of hair shedding after normalization. The correlation between the maximum RAHS (MRAHS) and the sulfotransferase activity as well as the therapeutic effect was calculated.

Results: A temporary increase in the amount of hair shedding was detected in the first 12 weeks. This increase has a longer duration in patients treated with 2% minoxidil compared to 5%. Its severity was correlated with the improvement of trichoscopy tests only in patients with 5% minoxidil but not in 2%. However, both patients in the 2% and 5% minoxidil groups had a significant association between the MRAHS and the improvement in BASP classification.

Conclusion: The amount of hair shedding increases temporarily after the topical minoxidil use, the level of which is a potential treatment efficacy.

目的:米诺地尔是治疗多种头发疾病的常规药物。本研究旨在探讨局部使用米诺地尔后头发脱落量增加的真实性。材料和方法:选择49例患者,局部应用2%或5%米诺地尔治疗雄激素性脱发,疗程24周。治疗前后每四周记录一次毛发脱落量。同时记录治疗前后的BASP分级及毛镜检查结果。相对脱毛量(RAHS)定义为归一化后记录的脱毛次数。计算最大RAHS (MRAHS)与硫转移酶活性及治疗效果的相关性。结果:在头12周检测到头发脱落量的暂时增加。使用2%米诺地尔治疗的患者与使用5%米诺地尔治疗的患者相比,这种增加的持续时间更长。其严重程度仅与使用5%米诺地尔的患者的毛镜检查改善相关,而与使用2%米诺地尔的患者无关。然而,2%米诺地尔组和5%米诺地尔组的患者在MRAHS和BASP分级改善之间存在显著关联。结论:局部使用米诺地尔后,毛发脱落量暂时增加,有一定的治疗效果。
{"title":"Whether the transient hair shedding phase exist after minoxidil treatment and does it predict treatment efficacy? A retrospective study in androgenetic alopecia patients.","authors":"Lingbo Bi, Haili Kan, Jing Wang, Yunbu Ding, Yuanbo Huang, Chaofan Wang, Yimei Du, Changpei Lu, Min Zhao, Weiling Sun, Tong Su, Weixin Fan","doi":"10.1080/09546634.2025.2480739","DOIUrl":"10.1080/09546634.2025.2480739","url":null,"abstract":"<p><strong>Purpose: </strong>Minoxidil is a routinely used drug in treating multiple hair disorders. This study aimed to investigate the facticity of the temporal increase in the hair shedding amount after topical use of minoxidil.</p><p><strong>Materials and methods: </strong>We selected 49 patients who used 2% or 5% minoxidil topically to treat androgenetic alopecia for 24 weeks. The amount of hair shedding was recorded every four weeks before and after the treatment. The BASP classification and trichoscopy test results were also recorded before and after the treatment. The relative amount of hair shedding (RAHS) was defined as the recorded number of hair shedding after normalization. The correlation between the maximum RAHS (MRAHS) and the sulfotransferase activity as well as the therapeutic effect was calculated.</p><p><strong>Results: </strong>A temporary increase in the amount of hair shedding was detected in the first 12 weeks. This increase has a longer duration in patients treated with 2% minoxidil compared to 5%. Its severity was correlated with the improvement of trichoscopy tests only in patients with 5% minoxidil but not in 2%. However, both patients in the 2% and 5% minoxidil groups had a significant association between the MRAHS and the improvement in BASP classification.</p><p><strong>Conclusion: </strong>The amount of hair shedding increases temporarily after the topical minoxidil use, the level of which is a potential treatment efficacy.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2480739"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effect of an herbal gel for the prevention of radiation dermatitis-related symptoms: an open-label randomized clinical trial. 一种草药凝胶预防放射性皮炎相关症状的效果:一项开放标签随机临床试验
Pub Date : 2025-12-01 Epub Date: 2025-04-14 DOI: 10.1080/09546634.2025.2489595
Simeng Ren, Jiayue Jin, Xiaoyue Wu, Baojin Han, Wenzheng Zhang, Feng Rong, Wei Hou, Qiuling Shi, Hongsheng Lin, Jie Liu

Purpose of the study: Radiation-induced dermatitis (RID) is the most frequent side effect of radiotherapy; however, no effective treatments are currently available. This study investigated the efficacy and safety of an herbal gel for preventing RID and associated symptoms in patients with cancer.

Materials and methods: Cancer patients were randomly assigned 1:1 in an open-label randomized clinical trial. Patients in the prophylactic group received preventative herbal gel treatment (one day before radiotherapy). Patients in the interventional group received herbal gel treatment (upon the development of grade 2 RID). Outcome measures were scored according to the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. Patient-reported skin symptoms (Skindex-16), quality of life (QLQ-C30), and adverse effects (CTCAE V4.0) were investigated.

Results: Among 71 participants, the prophylactic group showed significant relief with a medium effect size for itching, hurting, and burning or stinging (p < .05, effect size >0.5) compared to the interventional group. No statistically significant difference in the incidence of RID was found (51% in the prophylactic group vs. 53% in the interventional group, p = .91). The prophylactic application of the gel did not affect patient quality of life. No adverse reactions associated with the gel were observed.

Conclusions: Preventative herbal gel treatment can alleviate the radiation dermatitis-related symptoms with good safety, which indicates that gel could be an option for integration in patient care to improve RT in patients with breast, lung, and head and neck cancers.

研究目的:放射性诱发性皮炎(RID)是放疗最常见的副作用;然而,目前尚无有效的治疗方法。本研究调查了一种草药凝胶预防癌症患者RID和相关症状的有效性和安全性。材料与方法:肿瘤患者按1:1随机分组,采用开放标签随机临床试验。预防组患者在放疗前1天给予预防性中药凝胶治疗。介入组患者接受草药凝胶治疗(2级RID发生后)。结果测量是根据放射治疗肿瘤组和欧洲癌症研究和治疗组织进行评分的。研究了患者报告的皮肤症状(skinindex -16)、生活质量(QLQ-C30)和不良反应(CTCAE V4.0)。结果:在71名参与者中,与介入组相比,预防组在瘙痒、疼痛、灼烧或刺痛方面表现出显著的缓解,效果中等(p = 0.5)。RID的发生率无统计学差异(预防组为51%,干预组为53%,p = 0.91)。预防性应用凝胶不影响患者的生活质量。未观察到与凝胶相关的不良反应。结论:预防性中药凝胶治疗可缓解放射性皮炎相关症状,且安全性较好,提示凝胶可作为一种整合患者护理的选择,以改善乳腺癌、肺癌和头颈癌患者的放疗。
{"title":"Effect of an herbal gel for the prevention of radiation dermatitis-related symptoms: an open-label randomized clinical trial.","authors":"Simeng Ren, Jiayue Jin, Xiaoyue Wu, Baojin Han, Wenzheng Zhang, Feng Rong, Wei Hou, Qiuling Shi, Hongsheng Lin, Jie Liu","doi":"10.1080/09546634.2025.2489595","DOIUrl":"https://doi.org/10.1080/09546634.2025.2489595","url":null,"abstract":"<p><strong>Purpose of the study: </strong>Radiation-induced dermatitis (RID) is the most frequent side effect of radiotherapy; however, no effective treatments are currently available. This study investigated the efficacy and safety of an herbal gel for preventing RID and associated symptoms in patients with cancer.</p><p><strong>Materials and methods: </strong>Cancer patients were randomly assigned 1:1 in an open-label randomized clinical trial. Patients in the prophylactic group received preventative herbal gel treatment (one day before radiotherapy). Patients in the interventional group received herbal gel treatment (upon the development of grade 2 RID). Outcome measures were scored according to the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. Patient-reported skin symptoms (Skindex-16), quality of life (QLQ-C30), and adverse effects (CTCAE V4.0) were investigated.</p><p><strong>Results: </strong>Among 71 participants, the prophylactic group showed significant relief with a medium effect size for itching, hurting, and burning or stinging (<i>p</i> < .05, effect size >0.5) compared to the interventional group. No statistically significant difference in the incidence of RID was found (51% in the prophylactic group vs. 53% in the interventional group, <i>p</i> = .91). The prophylactic application of the gel did not affect patient quality of life. No adverse reactions associated with the gel were observed.</p><p><strong>Conclusions: </strong>Preventative herbal gel treatment can alleviate the radiation dermatitis-related symptoms with good safety, which indicates that gel could be an option for integration in patient care to improve RT in patients with breast, lung, and head and neck cancers.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2489595"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144055608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study. 口服罗氟司特治疗牛皮癣:一项现实世界24周的前瞻性队列研究
Pub Date : 2025-12-01 Epub Date: 2025-02-11 DOI: 10.1080/09546634.2025.2464107
Ana Maria Lé, Orhan Yilmaz, Martim Luz, Tiago Torres

Objective: Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.

Methods: Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.

Results: Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.

Conclusion: Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.

目的:银屑病是一种慢性炎症性皮肤病,具有显著的生理和心理负担,常伴有肥胖和心血管疾病等合并症。目前的治疗包括传统的全身治疗和靶向生物和非生物治疗,在安全性、有效性和成本方面存在一些局限性。罗氟米司特是一种选择性PDE4抑制剂,由于其抗炎作用和良好的安全性,显示出作为口服治疗银屑病的潜力。本研究旨在评估口服罗氟司特治疗中重度斑块型银屑病的实际疗效和安全性。方法:在葡萄牙的一个单一中心进行前瞻性队列研究,包括每日一次口服罗氟米司特500 mcg治疗的中度至重度牛皮癣的成年人。结果:在58例患者(基线PASI中位数13.7±5.5)中,63.0%的患者在第24周(mNRI)达到PASI < 5, 47.8%的PASI < 3, 21.7%的PASI < 1。体重减轻的占53.4%,平均减少6 kg±4.3。轻微的胃肠道症状很常见,但很少引起停药。无严重不良事件报告。结论:罗氟司特在治疗中重度斑块型银屑病中具有实际疗效和良好的安全性。额外的好处,包括体重减轻和不需要实验室监测,使其成为一种有希望的治疗选择,特别是对于患有合并症或获得生物治疗机会有限的患者。
{"title":"Oral roflumilast for psoriasis: a real-world 24-week prospective cohort study.","authors":"Ana Maria Lé, Orhan Yilmaz, Martim Luz, Tiago Torres","doi":"10.1080/09546634.2025.2464107","DOIUrl":"10.1080/09546634.2025.2464107","url":null,"abstract":"<p><strong>Objective: </strong>Psoriasis is a chronic inflammatory skin disease with significant physical and psychological burden, often associated with comorbidities such as obesity and cardiovascular disease. Current treatments include conventional systemic therapies and targeted biologic and non-biologic therapies, with several limitations related to safety, efficacy, and cost. Roflumilast, a selective PDE4 inhibitor, shows potential as an oral therapy for psoriasis due to its anti-inflammatory effects and favorable safety profile. This study aimed to evaluate the real-world effectiveness and safety of oral roflumilast in moderate-to-severe plaque psoriasis.</p><p><strong>Methods: </strong>Prospective cohort study at a single center in Portugal including adults with moderate-to-severe psoriasis treated with oral roflumilast 500 mcg once daily.</p><p><strong>Results: </strong>Among fifty-eight patients (baseline median PASI 13.7 ± 5.5), 63.0% achieved PASI < 5, 47.8% PASI < 3, and 21.7% PASI < 1 by week 24 (mNRI). Weight loss occurred in 53.4%, with a mean reduction of 6 kg ± 4.3. Mild gastrointestinal symptoms were common but rarely caused discontinuation. No serious adverse events were reported.</p><p><strong>Conclusion: </strong>Roflumilast demonstrated real-world effectiveness and a favorable safety profile in moderate-to-severe plaque psoriasis. Additional benefits, including weight loss and no need for laboratory monitoring, make it a promising treatment option, particularly for patients with comorbidities or limited access to biologic therapies.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2464107"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143401075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multicenter pilot study of the effectiveness and safety of a monopolar radiofrequency device for improving periorbital and facial fine wrinkles. 单极射频设备改善眶周和面部细小皱纹的有效性和安全性的多中心试点研究。
Pub Date : 2025-12-01 Epub Date: 2025-03-11 DOI: 10.1080/09546634.2025.2469633
Hee Joo Yang, Sun Young Choi, Joon Min Jung, Yoon-Seo Jo, Hye Sung Han, Young In Lee, Ju Hee Lee, Chong Hyun Won

Purpose: This study aimed to investigate the effectiveness and safety of a new monopolar radiofrequency device equipped with a 5 cm2 tip, against fine wrinkles around the eyes and cheeks.

Materials and methods: This multicentered, prospective pilot study involved treating participants with mild-to-moderate wrinkles on both periorbital areas and cheeks using the monopolar radiofrequency device for one session. One and four months after treatment, wrinkle reduction, overall esthetic improvement, adverse events, and vital signs were evaluated.

Results: The study involved 13 participants (age: 35-62 years) and on a five-point scale, periorbital wrinkles showed a significant reduction at 4 weeks (0.96 ± 0.65) and 16 weeks (1.04 ± 0.59). On a five-point scale, cheek wrinkles also decreased at weeks 4 and 16 (1.00 ± 0.55 and 1.12 ± 0.64, respectively). On a five-point scale (range: -1-3), overall global esthetic improvement was rated by the participants at weeks 4 and 16 to be 2.23 ± 0.80 and 2.31 ± 0.61, respectively. Adverse events were not observed during the follow-up.

Conclusion: A single session using the new monopolar radiofrequency device equipped with a 5 cm2 tip safely and effectively improves mild-to-moderate periorbital and facial wrinkles.

目的:本研究旨在探讨一种新型单极射频装置的有效性和安全性,该装置配有5平方厘米的尖端,用于治疗眼睛周围和脸颊周围的细纹。材料和方法:这项多中心前瞻性先导研究包括使用单极射频设备治疗眼眶周围和脸颊轻度至中度皱纹的参与者一个疗程。治疗后1个月和4个月,对皱纹减少、整体美观改善、不良事件和生命体征进行评估。结果:该研究涉及13名参与者(年龄:35-62岁),在五分制量表中,眼眶周围皱纹在4周(0.96±0.65)和16周(1.04±0.59)时显着减少。在五分制量表中,脸颊皱纹也在第4周和第16周减少(分别为1.00±0.55和1.12±0.64)。在五分制(范围:-1-3)中,参与者在第4周和第16周对整体审美改善的评分分别为2.23±0.80和2.31±0.61。随访期间未观察到不良事件。结论:单次使用配有5 cm2尖端的新型单极射频装置,安全有效地改善了轻度至中度眶周和面部皱纹。
{"title":"A multicenter pilot study of the effectiveness and safety of a monopolar radiofrequency device for improving periorbital and facial fine wrinkles.","authors":"Hee Joo Yang, Sun Young Choi, Joon Min Jung, Yoon-Seo Jo, Hye Sung Han, Young In Lee, Ju Hee Lee, Chong Hyun Won","doi":"10.1080/09546634.2025.2469633","DOIUrl":"10.1080/09546634.2025.2469633","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to investigate the effectiveness and safety of a new monopolar radiofrequency device equipped with a 5 cm<sup>2</sup> tip, against fine wrinkles around the eyes and cheeks.</p><p><strong>Materials and methods: </strong>This multicentered, prospective pilot study involved treating participants with mild-to-moderate wrinkles on both periorbital areas and cheeks using the monopolar radiofrequency device for one session. One and four months after treatment, wrinkle reduction, overall esthetic improvement, adverse events, and vital signs were evaluated.</p><p><strong>Results: </strong>The study involved 13 participants (age: 35-62 years) and on a five-point scale, periorbital wrinkles showed a significant reduction at 4 weeks (0.96 ± 0.65) and 16 weeks (1.04 ± 0.59). On a five-point scale, cheek wrinkles also decreased at weeks 4 and 16 (1.00 ± 0.55 and 1.12 ± 0.64, respectively). On a five-point scale (range: -1-3), overall global esthetic improvement was rated by the participants at weeks 4 and 16 to be 2.23 ± 0.80 and 2.31 ± 0.61, respectively. Adverse events were not observed during the follow-up.</p><p><strong>Conclusion: </strong>A single session using the new monopolar radiofrequency device equipped with a 5 cm<sup>2</sup> tip safely and effectively improves mild-to-moderate periorbital and facial wrinkles.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":"36 1","pages":"2469633"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143607186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
PCSK9 is upregulated and correlated with more severe disease condition but fails to predict treatment outcomes in psoriasis patients. PCSK9上调并与更严重的疾病状况相关,但不能预测银屑病患者的治疗结果。
Pub Date : 2025-12-01 Epub Date: 2025-06-04 DOI: 10.1080/09546634.2025.2482867
Xuwen Yin, Lei Shi, Ni Zhang, Heng Li, Jianwen Long, Xinjian Yu

Background: Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) not only regulates cholesterol metabolism and cardiovascular disorder but also modifies inflammatory response and autoimmunity.

Objective: This study investigated the relation of PCSK9 to clinical features and treatment outcomes in psoriasis patients.

Methods: One hundred and five psoriasis patients who initiated systemic treatment due to moderate-to-severe disease condition were enrolled. Baseline characteristics and treatment response after 12-week treatment were collected. Their serum samples before treatment initiation were collected and sent to PCSK9 detection by enzyme-linked immunosorbent assay. Serum PCSK9 was also detected in 30 healthy subjects.

Results: PCSK9 level was 2-fold times in psoriasis patients vs. healthy subjects. PCSK9 could predict psoriasis risk with AUC of 0.777. By optimum cutoff value of 179 ng/ml, PCSK9 had the best predictive potential for psoriasis risk. PCSK9 quartile was positively correlated with BMI, hyperlipemia history, PASI, and sPGA. However, PCSK9 quartile was not correlated with PASI 75 response, PASI 90 response, or sPGA 0/1 response at week 12.

Conclusion: PCSK9 is upregulated and correlated with severe disease condition, but fails to predict treatment outcomes in psoriasis patients.

背景:蛋白转化酶枯草素/可辛9型(PCSK9)不仅调节胆固醇代谢和心血管疾病,还能调节炎症反应和自身免疫。目的:探讨PCSK9与银屑病患者临床特征及治疗效果的关系。方法:入选105例因中重度病情而开始全身治疗的银屑病患者。收集治疗12周后的基线特征和治疗反应。收集治疗开始前的血清样本,用酶联免疫吸附法检测PCSK9。同时对30名健康人进行血清PCSK9检测。结果:银屑病患者的PCSK9水平是健康人的2倍。PCSK9预测银屑病风险的AUC为0.777。通过179 ng/ml的最佳临界值,PCSK9对银屑病风险的预测潜力最大。PCSK9四分位数与BMI、高脂血症史、PASI、sPGA呈正相关。然而,PCSK9四分位数与第12周的PASI 75反应、PASI 90反应或sPGA 0/1反应无关。结论:PCSK9在银屑病患者中表达上调,与病情严重程度相关,但不能预测治疗结果。
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The Journal of dermatological treatment
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