A Multicenter Study to Assess the Feasibility of Gleolan (ALA / Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration

This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.
For the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.

开始日期2025-12-01

申办/合作机构

University of Pittsburgh

[+4]

NCT07038278

/ Not yet recruiting早期临床1期IIT

5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)

The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.

开始日期2025-12-01

申办/合作机构

University of Colorado Denver

[+1]

NCT07201376

/ Not yet recruitingN/AIIT

Tissue Oxygen Imager

The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).

开始日期2025-11-01

申办/合作机构

Dartmouth-Hitchcock Medical Center

[+1]

100 项与盐酸氨酮戊酸相关的临床结果

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100 项与盐酸氨酮戊酸相关的转化医学

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100 项与盐酸氨酮戊酸相关的专利（医药）

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7,818

项与盐酸氨酮戊酸相关的文献（医药）

2026-03-01·Synthetic and Systems Biotechnology

Systems metabolic engineering of dual pathways with stage-specific activation for high-level 5-aminolevulinic acid production in Escherichia coli

Article

作者: Li, Changgeng ; Shi, Tang'en ; Liu, Yanghao ; Yu, Zichen ; Xu, Qingyang ; Zhao, Siyu ; Chen, Zhichao ; Miao, Yu ; Li, Lanxiao ; Ma, Ling

5-Aminolevulinic acid (5-ALA) is an important non-proteinogenic amino acid with wide applications in agriculture and medicine. To achieve high-level microbial production, this study established a dual-pathway reconstruction strategy in Escherichia coli by integrating the endogenous C5 pathway with an inducible exogenous C4 pathway. Multi-copy overexpression of gltX, hemA, and hemL, combined with enhanced glutamate supply and the introduction of a non-oxidative glycolysis pathway, effectively increased the C5 pathway flux and carbon efficiency, while product toxicity was significantly alleviated by strengthening efflux mechanisms and oxidative stress tolerance. A quorum sensing-based regulatory system was employed to dynamically regulate hemB expression, thereby balancing cell growth and 5-ALA biosynthesis, and a controlled glycine feeding strategy specifically activated the C4 pathway during the later fermentation stage, forming a stage-specific dynamic activation mechanism. Promoter regulation of sucC/sucD expression and enhanced endogenous PLP biosynthesis further stabilized the C4 flux. Fed-batch fermentation in a 5 L bioreactor resulted in a final 5-ALA titer of 37.34 g/L, demonstrating the industrial potential of this systems metabolic engineering strategy combining dual pathways and stage-specific activation control.

2025-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy analysis of 5-aminolevulinic acid photodynamic therapy for vulvar lichen sclerosus in women of childbearing age

Article

作者: Zhu, Dongning ; Shi, Chunyu ; Jia, Yu ; Dang, Yanling ; Shang, Qian ; Yang, Lijuan

OBJECTIVE:

To investigate the efficacy and long-term durability of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in treating vulvar lichen sclerosus (VLS) in women of childbearing age.

METHODS:

Fifty-five patients with VLS who had failed long-term repeated pharmacological treatments (mean disease duration: 3.6 ± 1.4 years)were enrolled. All participants underwent four sessions of ALA-PDT. Follow-up evaluations were conducted for six months after treatment. Outcomes were assessed using the Cattaneo clinical symptom and sign score and the Dermatology Life Quality Index (DLQI) questionnaire at baseline, after four treatments, and at 3-6 months post-treatment.

RESULTS:

At the 6-month follow-up, efficacy rates were 81.8% for pruritus relief, 67.3% for skin elasticity restoration, 63.6% for skin color improvement, and 72.7% for lesion area reduction. Pain was the only reported adverse reaction during treatment.

CONCLUSION:

20% ALA-PDT is a safe, effective, and durable therapeutic option for VLS with minimal side effects. Notably, it provides a viable alternative for patients unresponsive to conventional therapies.

2025-12-01·JOURNAL OF NEURO-ONCOLOGY

Photodynamic therapy for glioblastoma: a narrative review

Review

作者: Huq, Sakibul ; Colan, Jhair ; Hadjipanayis, Constantinos ; Frederico, Stephen C ; Rentzeperis, Frederika ; Price, Gabrielle

PURPOSE:

Glioblastoma (GBM) remains one of the most aggressive primary brain tumors with poor survival outcomes and a lack of approved therapies. A promising novel approach for GBM is the application of photodynamic therapy (PDT), a localized, light-activated treatment using tumor-selective photosensitizers. This narrative review describes the mechanisms, delivery systems, photosensitizers, and available evidence regarding the potential of PDT as a novel therapeutic approach for GBM.

METHODS:

A comprehensive review of the preclinical and clinical literature was conducted on the role of PDT for GBM. Special emphasis was placed on PDT's mechanisms of action, immunomodulatory effects, delivery systems, and combinatorial potential with other treatment regimens. All clinical trials on this topic were reviewed and described.

RESULTS:

PDT exerts tumor-specific cytotoxic effects via reactive oxygen species generation, vascular disruption, and immune activation. Photosensitizers such as 5-aminolevulinic acid (5-ALA), chlorins, and phthalocyanines demonstrate selective accumulation in glioma cells and enhance treatment precision. Preclinical studies demonstrate that PDT can induce apoptosis, improve blood-brain barrier permeability, and synergize with existing chemotherapeutics. Early-phase clinical trials, including the INDYGO and talaporfin sodium-based studies, report promising safety profiles and extended survival in newly diagnosed and recurrent GBM patients.

CONCLUSION:

PDT offers a novel targeted approach for improving local control of GBM. With continued innovation in photosensitizer design, delivery technologies, and combinatorial strategies, PDT holds promise as a viable therapeutic adjunct in GBM treatment. Further clinical validation through randomized controlled trials is warranted to establish its efficacy and gain regulatory approval with the eventual goal of integration into standard neuro-oncology practice.

132

项与盐酸氨酮戊酸相关的新闻（医药）

2025-11-02

·优麦会讯

中华医学会第九届皮肤科实验研究学术会议(CSID 2025)11月1日在沈阳继续进行中

中华医学会第九届皮肤科实验研究学术会议（CSID）Psoriasis 1专题会议与大会特邀报告第一时段：银屑病研究专场 2025年11月1日上午，中华医学会第九届皮肤科实验研究学术会议（CSID）在沈阳Ballroom 1+2厅举行了“Psoriasis 1”专题会议。本场会议由安徽医科大学第一附属医院肖风丽教授与中国医学科学院皮肤病医院姚煦教授共同主持，聚焦银屑病的免疫发病机制与创新治疗策略。会议首先进行了大会特邀报告。上海中医药大学附属岳阳中西医结合医院李欣教授作题为 “Immunological Mechanisms of Psoriasis: Traditional Chinese Medicine Strategies” 的报告，系统阐述了中医药在银屑病免疫调控中的作用机制与临床转化价值，为中西医结合治疗提供了新的理论支撑与实践路径。随后，中南大学湘雅医院彭聪教授作报告 “The Role of LPA/LPARs Axis in Pathogenesis of Psoriasis”，介绍了LPA/LPARs信号轴在银屑病发病过程中的关键调控作用及其作为潜在治疗靶点的研究进展。在随后的并行专题讨论环节，多位专家围绕银屑病的免疫炎症通路与分子机制作了精彩报告。北京大学第三医院梁晓丰博士报告 “Biologics as a Novel Treatment Option for Palmoplantar Pustulosis: A Comprehensive Review”，系统总结了生物制剂在掌跖脓疱型银屑病治疗中的最新研究进展；复旦大学附属华山医院王轶伦博士作报告 “Adjunctive Therapy of Topical PDE4 Inhibition for Generalized Pustular Psoriasis: Targeting Myeloid Activation–Lipid Depletion”，深入探讨了PDE4抑制剂在广泛性脓疱型银屑病中的免疫代谢学机制及临床应用价值；哈尔滨医科大学附属第一医院王宥霖博士报告 “YTHDF2 Contributes to Psoriasis by Promoting Proliferation and Inflammatory Response through Regulation of the Wnt Signaling Pathway”，揭示表观修饰因子YTHDF2通过调控Wnt信号通路促进角质形成细胞增殖与炎症反应的新机制；华北理工大学附属医院王义睿博士报告 “Deciphering Mechanics of dsDNA Triggering AIM2 Inflammasome to Dictate Psoriasis”，阐明了双链DNA通过激活AIM2炎性小体参与银屑病免疫反应的分子机制；空军军医大学西京医院王家琪博士作报告 “PD-L1⁺ Neutrophils Drive Autoinflammation in Generalized Pustular Psoriasis via an IL-36γ–SLC13A3–Itaconate Axis”，提出PD-L1阳性中性粒细胞通过IL-36γ–SLC13A3–Itaconate代谢通路驱动广泛性脓疱型银屑病自体炎症的新发现。本场会议内容丰富、观点前沿，展示了国内学者在银屑病免疫调控、代谢重编程与靶向治疗领域的最新研究成果，为未来银屑病的精准防治提供了新的思路与方向。第二时段：大会特邀报告会 2025年11月1日上午10时，中华医学会第九届皮肤科实验研究学术会议（CSID）在沈阳主会场厅继续举行大会特邀报告会。本场由日本东海大学的Akira Ozawa教授与中国医学科学院皮肤病医院陆前进教授共同主持，汇聚了来自日本、法国、韩国、英国及中国多位国际知名专家，围绕皮肤炎症、银屑病及特应性皮炎的发病机制与精准医学策略展开高水平学术交流。会议首先由日本京都大学Kenji Kabashima教授作题为 “Exploring the Pathogenesis of Atopic Dermatitis from Multiple Perspectives” 的报告。Kabashima教授从多维视角深入剖析特应性皮炎的发病机制，结合免疫学、神经生物学及皮肤屏障研究的最新成果，引发现场热烈讨论。报告结束后，大会组委会向Kenji Kabashima教授颁发纪念证书，以感谢他在国际皮肤免疫研究领域的杰出贡献。随后，法国巴黎大学圣路易医院Hervé Bachelez教授作报告 “From Disease Taxonomy to Precision Medicine: The Multiple Impacts of Single Gene Models of Psoriasis”，系统阐述了单基因银屑病模型在疾病分类、病理机制及精准医学策略制定中的关键价值，展示了以遗传学为基础的银屑病精准诊疗新思路。报告结束后，大会组委会向Hervé Bachelez教授颁发纪念证书，以感谢他在银屑病研究领域的杰出贡献。会议第二阶段由南方医科大学皮肤病医院杨斌教授与浙江大学医学院附属第一医院乔建军教授共同主持。上海交通大学医学院附属第一人民医院王宏林教授首先作报告 “Novel Dendritic Cell-Driven Pathways in Skin Inflammation: Targeting Neuro-Immune Crosstalk in Vitiligo and Relapse-Prone Cells in Psoriasis”，介绍了树突状细胞驱动的皮肤炎症新通路，重点探讨了白癜风与易复发银屑病中神经—免疫互作的关键调控机制。接着，首尔医科大学Seong Jin Jo教授分享了关于脓疱型银屑病的最新研究进展，系统总结了该病亚型的免疫病理特征及治疗策略更新。报告结束后，与会专家围绕脓疱型银屑病的发病机制、临床试验及靶向治疗的转化研究展开了热烈讨论，现场学术氛围浓厚。最后，来自英国利兹大学的Laura Savage教授作了题为 “Early Intervention in Psoriatic Disease” 的报告。Savage教授强调了银屑病及其相关关节病变的早期干预重要性，提出了基于免疫监测和风险分层的个体化管理策略。在随后的讨论环节中，与会专家围绕个体化生物制剂的使用策略、免疫监测在治疗反应预测中的价值以及Treg细胞在免疫耐受与疾病调控中的潜在作用展开了热烈探讨。本场大会特邀报告会内容丰富、学术水平高，涵盖从基础机制到临床转化的多个维度，充分展示了国际皮肤科学界在炎症性皮肤病领域的最新研究进展与多学科融合趋势，为炎症性皮肤病的精准防治提供了新的研究方向与合作契机。 11月1日上午伦敦厅中华医学会第九届皮肤科实验研究学术会议（CSID）特应性皮炎专场 “Atopic dermatitis-1” 学术会议于11月1日在酒店二层伦敦厅成功举行。会议由中南大学湘雅二医院梁云生教授与复旦大学附属华山医院李巍教授共同主持，汇聚了来自国内外多家顶尖科研与临床机构的青年学者，围绕特应性皮炎的免疫调控、代谢机制及细胞互作等前沿课题展开深入研讨。第一时段：机制前沿：免疫、代谢与神经环路的多维解析安徽医科大学附属第一医院何子莹博士汇报了“IL-7/IL-7R signaling drives macrophage extracellular trap–keratinocyte crosstalk to exacerbate atopic dermatitis”，揭示IL-7/IL-7R信号通过巨噬细胞胞外捕获网与角质形成细胞间的互作，加剧特应性皮炎炎症反应的新机制。北京大学人民医院孙一杰博士带来“Mechanism of Senescent Fibroblast Regulating Macrophage Metabolic Reprogramming in Elderly Atopic Dermatitis”，系统阐述衰老成纤维细胞如何调控巨噬细胞代谢重编程，从而影响老年性特应性皮炎的免疫病理过程。安徽医科大学附属第一医院王宇博士汇报“TMEM232 Disrupts Epidermal Barrier Function via PI3K/AKT-Mediated Keratinocyte Imbalance in Atopic Dermatitis”，指出TMEM232通过PI3K/AKT通路介导角质形成细胞失衡，破坏皮肤屏障功能，是AD发病的重要分子基础。哈尔滨医科大学附属第二医院王晨博士带来“Identification of Potential Hub Genes and Immune Inflammatory Function of BAX in Atopic Dermatitis”，通过生物信息学及功能实验证实BAX在特应性皮炎免疫炎症调控中的关键作用，为潜在诊疗靶点的筛选提供了新方向。第二时段：系统调控：从神经免疫到细胞修复的新视角复旦大学附属华山医院余愫博士分享“Sympathetic nerve dysfunction exacerbates skin inflammation in atopic dermatitis”，揭示交感神经功能障碍在皮肤炎症放大的机制，提示神经免疫互作在AD中的重要意义。兰州大学赵雪萍博士报告“hUCMSC-exo ameliorates atopic dermatitis by regulating mitochondrial damage caused by oxidative stress in keratinocytes”，提出人脐带间充质干细胞外泌体通过调控角质形成细胞氧化应激与线粒体损伤，有效改善AD病变，为细胞外泌体治疗提供实验依据。重庆医科大学附属第一医院陈爽博士以“Single-Cell and Spatial Transcriptomics Reveal a TRM–Keratinocyte Axis Underlying the Proliferation–Inflammation–Barrier Failure Triad in Atopic Dermatitis”为题，结合单细胞与空间转录组学技术，揭示TRM–角质形成细胞互作驱动的“增殖–炎症–屏障失衡”三联机制。重庆医科大学附属第一医院王瑞尧博士分享了“Clinical Observation of a Novel Microbial-Modulating Dermal Protective Agent in Patients with Mild to Moderate Acne: A Self-Controlled Trial”，探讨新型微生态调节性皮肤保护剂在轻中度痤疮患者中的临床疗效，为炎症性皮肤病的微生物干预提供了可借鉴的思路。会议总结本次 “Atopic dermatitis-1” 专场会议以“免疫机制阐释与治疗策略创新”为核心，青年学者们从分子信号、细胞互作、代谢通路及神经调控等多层面系统解析了特应性皮炎的复杂病理网络。会议讨论气氛热烈，思想碰撞激发了诸多新思路，充分展示了青年科研力量在免疫性皮肤病基础与转化研究领域的学术深度与创新潜力。 11月1日上午巴黎厅中华医学会第九届皮肤科实验研究学术会议（CSID）临床研究专场临床研究是推动皮肤科诊疗进步的核心动力。2025 年 11月1日08:00-09:40，“Clinical Research 1” 学术会议于二层巴黎厅如期召开，由广州市皮肤病医院的叶兴东教授和浙江大学医学院附属第二医院的景璟教授主持，集结新疆、广州、上海、杭州等多地知名医疗机构的专家，围绕卡波西肉瘤、维 A 酸应用、免疫相关皮肤不良反应（irAEs）等临床热点深度研讨，为皮肤科临床研究的转化与创新注入新活力。新疆自治区人民医院的石静艺博士带来 “Kaposi Sarcoma: From Clinical Presentation to Molecular Mechanisms”，系统解析卡波西肉瘤从临床表型到分子机制的多维度特征，为其精准诊疗提供理论支撑。广州市皮肤病医院的张锡宝教授分享 “Retinoids in dermatology”，回顾维 A 酸类药物在皮肤科的经典应用场景，结合最新研究进展探讨其在痤疮、银屑病、皮肤肿瘤等疾病中的优化用药策略。复旦大学附属中山医院的杨骥教授阐述 “Clinical phenotypes and treatments of cutaneous irAEs”，聚焦免疫治疗相关皮肤不良反应的临床表型分类与个体化治疗方案，为肿瘤免疫治疗的皮肤安全管理提供实践指导。海南省第五人民医院的张威博士汇报 “Clinical Classification of Ota Nevus in Hainan Region and Observation of Therapeutic Efficacy using Q-switched 755nm Laser: A Single-Center 8-Year Follow-up Analysis”，基于海南地区单中心 8 年随访数据，解析太田痣的临床分类及调 Q755nm 激光的长期疗效，为色素性疾病的区域化诊疗提供参考。杭州市第三人民医院的金小帆博士开展 “Ultraviolet-induced Fluorescence Dermoscopy in Detecting Follicular Openings in Alopecia Areata”，探索紫外线诱导荧光皮镜在斑秃毛囊开口检测中的应用价值，为斑秃的早期评估与疗效监测提供新工具。河北医科大学第一医院的王斌博士分享 “A Novel Barrier-Recovery Topical Formulation Containing Artemisia annua Extract Significantly Enhances Skin Barrier Restoration After Fractional Carbon Dioxide Laser Treatment: Results From A Prospective, Open-label, Randomized Controlled Clinical Trial”，通过前瞻性随机对照试验，验证含青蒿提取物的外用制剂在二氧化碳激光术后皮肤屏障修复中的显著作用，为医美术后护理提供创新方案。上海市皮肤病医院的尹玥博士讲解 “Kyrle’s disease following topical therapy with antibiotic agents and keratolytics”，汇报抗生素联合角质溶解剂外用治疗 Kyrle 病的临床案例，为罕见皮肤疾病的局部治疗提供实践经验。会议总结本次 “Clinical Research 1” 学术会议，以 “疾病机制解析 + 临床方案优化 + 创新技术应用” 为核心，覆盖肿瘤皮肤表现、经典药物应用、免疫不良反应、色素性疾病、毛发疾病、医美术后护理及罕见病等多个领域。多中心专家的智慧碰撞，不仅深化了对皮肤疾病临床特征与治疗策略的理解，更推动了临床研究成果向诊疗实践的转化，为皮肤科临床水平的提升注入强劲动力。 11月1日上午柏林厅中华医学会第九届皮肤科实验研究学术会议（CSID）Pigmentation, Melanoma & Vitiligo 专场在大会上午的“Pigmentation, Melanoma & Vitiligo”专场中，吉林大学第一医院的李珊山教授与中国医学科学院皮肤病医院的陈旭教授担任主持。该专场围绕黑色素生成调控、黑色素瘤机制以及白癜风与黄褐斑的分子病理展开了多角度探讨，展示了色素性疾病领域的最新研究成果。重庆医科大学附属第一医院的陈瑾教授作专题“The Role of Fibroblast in Vitiligo”，系统阐述了成纤维细胞在白癜风发病过程中的免疫调控作用及其与黑色素细胞相互作用的机制，为皮肤色素重建提供了新思路。北京大学第一医院的田杰博士汇报了“A distinct subgroup with Schwann-like differentiation presents immune resistance and poor prognosis in plantar melanoma”，揭示了一类具施旺细胞样分化特征的黑色素瘤亚群在免疫逃逸与不良预后中的独特生物学特征。华中科技大学同济医学院附属同济医院的李东博士在题为“WTAP regulates melanoma cell proliferation and migration through KLF9”的报告中，探讨了WTAP通过调控KLF9影响黑色素瘤细胞增殖与迁移的分子机制，深化了对表观调控在肿瘤进展中作用的理解。空军军医大学第一附属医院的杨钰琪博士报告“GSDME acts as an epigenetic modifier to promote melanoma development via centriole biogenesis regulator PLK4”，揭示了GSDME通过调节PLK4促进黑色素瘤发生的表观遗传机制。昆明医科大学第一附属医院的贾肖蓉博士以“Deciphering the Heterogeneity of Fibroblasts in Melasma and Their Molecular Mechanisms in Regulating Melanin Metabolism Based on Single-Cell Transcriptomics”为题，基于单细胞转录组技术解析了黄褐斑中成纤维细胞的异质性及其在黑色素代谢调控中的作用。南昌大学第一附属医院的冯南飞博士报告“Multi-Omics Regulatory Networks of Mitophagy Genes in Melanoma and Construction of Prognostic Models”，从多组学角度建立了黑色素瘤线粒体自噬基因的调控网络及预后模型，为精准预后评估提供了新的分子依据。南方医科大学皮肤病医院的李承意博士的研究“Enhancement of Anti-PD-1 Efficacy in Malignant Melanoma through Mannose Production by Bifidobacterium animalis and Activation of Cytotoxic CD8+ T Cells”揭示了益生菌代谢产物通过激活细胞毒性T细胞显著增强抗PD-1治疗疗效。天津市中医药研究院附属医院的雷东云博士在报告“Development and Validation of Chimeric Antigen Receptor T Cell Therapy for Acral Melanoma”中，介绍了针对肢端黑色素瘤的CAR-T细胞治疗研发进展，为难治性黑色素瘤治疗提供了新方向。最后，浙江大学医学院附属第二医院的崔英哲博士以“SPRY1 Deficiency in Keratinocytes Induces Follicular Melanocyte Stem Cell Migration to the Epidermis through p53/Stem Cell Factor/C-KIT Signaling”为题，揭示了角质形成细胞中SPRY1缺失通过p53/SCF/C-KIT信号促进毛囊黑色素干细胞迁移的新机制，为色素再生研究提供了重要线索。本场报告内容丰富，涵盖细胞代谢、免疫调控、信号转导及临床转化等多个层面，充分展示了色素性皮肤病领域的科研活力与创新潜能。 11月1日上午北京厅中华医学会第九届皮肤科实验研究学术会议（CSID）银屑病和毛发专场银屑病作为免疫介导的慢性炎症性皮肤病，其发病机制与临床干预的探索始终是皮肤科领域的核心命题。毛发相关的研究新进展究也同样备受关注。2025年11月1日上午，“Psoriasis & Hair” 学术会议在酒店二层北京厅重磅召开，会议由杨勇教授和赵晴教授分别主持，集结中南大学湘雅医院、复旦大学附属华山医院、清华大学附属北京清华长庚医院、中山大学孙逸仙纪念医院、上海市皮肤病医院、中日友好医院、杭州市第三人民医院等多家知名机构的青年学者，围绕银屑病及毛发疾病免疫调控、细胞信号通路、代谢异常、神经机制、表观遗传学及新型治疗策略等多个维度深度研讨，为领域创新发展注入青春动能。复旦大学附属华山医院于宁教授带来 “Liver injury as a comorbidity in psoriasis”的报告，系统分析了银屑病患者肝损伤的临床相关性及机制基础，提出了银屑病系统性疾病管理的新视角。清华大学附属北京清华长庚医院赵邑教授分享“Comprehensive management for psoriasis”，强调多学科协作与个体化管理在银屑病综合治疗中的重要性。中南大学湘雅医院严镕璇博士阐述“Cuproptosis facilitates psoriasis by regulating the α-ketoglutarate/H3K4me3/Ferritin Heavy Chain 1 signaling pathway-mediated ferroptosis”，揭示了铜死亡与铁死亡在银屑病发病中的交叉机制，为抗炎干预提供了新的分子靶点。中南大学湘雅医院金利平博士分享“RIPK1 modulates the maturation of dendritic cells to promote psoriasis through IRF3 signaling pathway”，提出树突状细胞成熟与RIPK1信号在银屑病免疫病理中的关键作用。中日友好医院张燕亭博士带来“Experimental Technical Strategies for Research on Central Nervous System Complications of Psoriasis: From Neural Circuit Analysis to Behavioral Modulation”，介绍了银屑病合并中枢神经系统异常的实验策略，展示了皮肤与神经相互作用的研究新方向。中山大学孙逸仙纪念医院任婕如博士介绍“Indole-3-lactic acid ameliorates psoriasis through aryl hydrocarbon receptor activation”，强调了肠道代谢产物与AHR信号的潜在治疗价值。杭州市第三人民医院章红艳博士分享“TRPV4-Mediated TFEB Regulation of ORSK Autophagy by NR Mitigates Androgenetic Alopecia in Mice”，揭示了TRPV4通路在雄激素性脱发中的保护机制，为毛发再生研究提供了新的实验依据。上海市皮肤病医院杨楠博士阐述“Baseline Th17/Tc17 and LAG-3 Levels Serve as Predictive Biomarkers for Early Ixekizumab Response in Psoriasis”，通过临床数据分析，提出Th17/Tc17及LAG-3可作为生物制剂疗效早期预测指标，为精准用药奠定了基础。此次“Psoriasis & Hair” 学术会议以“前沿机制探索 + 创新疗法开发”为主线，展示了中国青年学者在基础研究与临床转化领域的科研实力与学术担当。未来，CSID银屑病与毛发专场将继续搭建国际化、高水平的学术交流平台，助力我国皮肤科科研工作向更深层次发展，为患者带来更多治愈希望。 11月1日上午罗马厅中华医学会第九届皮肤科实验研究学术会议（CSID）General Topics1专场中华医学会第九届皮肤科实验研究学术会议（CSID）于2025年10月31日 - 2025年11月2日在辽宁沈阳富力万达文华酒店举行。 2025年11月1日，“General Topics 1” 学术会议在酒店二层罗马厅重磅召开，会议由天津医科大学总医院王惠平教授、浙江大学医学院附属邵逸夫医院程浩教授主持。中国医科大学附属盛京医院吴严教授带来“LAPTM5 Exacerbates STING-mediated Inflammation Induced by LL-37 through Stabilizing STING in Rosacea”,该研究聚焦玫瑰痤疮，题目表明LAPTM5通过稳定STING加重LL-37诱导的STING介导炎症。研究假设LAPTM5调控STING通路参与玫瑰痤疮炎症，结果显示LAPTM5是玫瑰痤疮中与STING相关的基因，在患者巨噬细胞中高表达，且LL-37处理的小鼠皮损中其表达升高，参与炎症过程。上海交通大学医学院附属仁济医院的鞠强教授的研究“The role and significance of barrier defects of appocrine glands in hidradenitis suppurativa and related diseases”显示，顶泌汗腺屏障缺陷在化脓性汗腺炎（HS）及相关疾病中具有重要作用。HS早期即出现顶泌汗腺损伤且与炎症相关，受损顶泌汗腺会释放特定角蛋白至真皮层，这些角蛋白参与炎症过程，表明顶泌汗腺在HS发病机制中扮演关键角色。上海市皮肤病医院的闫语博士分享“Multi-omics Analysis Reveals Photodynamic Therapy Ameliorating Skin Photoaging by Improving Cellular Senescence through Mitohormes is-Mediated”，通过多组学分析发现，光动力疗法（PDT）通过线粒体 hormesis 介导的 citrate 含量降低改善细胞衰老，从而缓解皮肤光老化。安徽医科大学公共卫生学院的张家祥博士带来“LKB1/ AMPK deficiency aggravates mitochondrial DNA leakage via m TOR-dependent mitophagy damage in liver injury sensitized by trichloroethylene”，揭示LKB1/AMPK缺乏通过mTOR依赖性线粒体自噬损伤加剧三氯乙烯致敏肝损伤中的线粒体DNA泄漏。安徽医科大学附属第一医院的王明欣博士分享了“Segmental Anhidrosis Following Herpes Zoster: A Rare Autonomic Complication”，介绍了带状疱疹后节段性无汗症这一种罕见的自主神经并发症。东莞市人民医院的刘文琪博士汇报“Adverse Reactions and Management of Adult Patients with Neurofibromatosis Type 1-Associated Plexiform Neurofibroma Treated with Selumetinib: Report of Two Unique Cases”，介绍了司美替尼治疗1型神经纤维瘤病相关丛状神经纤维瘤成年患者的不良反应及处理的两例独特病例报告。交大二附院的张育飞博士介绍“Basophil-derived IL-4/IL-13 orchestrates macrophage polarization and accelerates cutaneous wound healing”，揭示嗜碱性粒细胞来源的IL-4/IL-13在协调巨噬细胞极化和加速皮肤伤口愈合中发挥着重要作用。上海市长征医院的刘祎博士带来“Changing Global Epidemiological Landscape and Treatment Options of Exophiala jeanselmei Infection:A Retrospective Analysis of 43-Year Real-World Outcomes”,详细阐述了甄氏外瓶霉感染的全球流行病学特征变化及治疗选择。中国人民解放军空军军医大学第一附属医院的张晨博士分享了“IDO-1/KYN/AHR axis regulates mitochondria-dependent keratinocyte apoptosis in severe drug-induced skin reactions”,揭示了IDO-1/KYN/AHR轴在严重药物性皮肤反应中调节线粒体依赖性角质形成细胞凋亡的机制。会议总结此次会议中来自各地的学者介绍了多种皮肤疾病的临床及基础研究，并通过交流碰撞出思维的火花，为患者带来更多治愈希望。 11月1日上午马德里厅 CSID 2025特应性皮炎与临床研究专场 2025年11月1日上午，中华医学会第九届皮肤科实验研究学术会议“特应性皮炎与临床研究”主题会在马德里厅举行。本场会议由来自浙江大学医学院附属第一医院的乔建军教授与浙江大学医学院附属第二医院的劳力民教授共同主持，聚焦特应性皮炎及其他常见皮肤病的临床研究成果与治疗新进展。上海市皮肤病医院的张国龙博士率先带来题为“Mechanism study of ALA-PDT combined with immunotherapy for Cutaneous squamous cell carcinoma”的专题发言，深入探讨了光动力疗法联合免疫治疗在皮肤鳞状细胞癌中的作用机制。上海市皮肤病医院的徐抑非博士以“Association of BMI, BMR, BSA, and Body Weight with Psoriasis Severity and Treatment Response: Evidence from a Real-World Cohort”为题，通过真实世界研究数据，分析了人体测量学指标与银屑病严重程度及治疗反应的关联。新疆维吾尔自治区人民医院的赵舒文博士分享了“Clinical Efficacy and Safety Assessment of Radiotherapy for Kaposi's Sarcoma: A Multicenter Retrospective Analysis”，系统评估了放射治疗在卡波西肉瘤中的疗效与安全性。中国医科大学附属第一医院的韩旭博士汇报了“Cobotide Injection vs Pregabalin for Moderate-to-Severe Acute Herpes Zoster Neuralgia and Prevention of Postherpetic Neuralgia: A Randomized, Double-Blind, Positive-Controlled, Multicenter Trial”，比较了新型药物与传统用药在带状疱疹神经痛治疗中的优劣。上海市皮肤病医院的林苏扬博士带来“The Role of the IL-27/STAT1 Axis in Promoting TNF-α Expression and Skin Inflammation in Atopic Dermatitis”，从分子机制角度揭示了IL-27/STAT1轴在特应性皮炎炎症中的作用。首都医科大学的王飘博士阐述了“Phytic Acid Improves the Skin Barrier Function in Murine Models of Atopic Dermatitis Through Skin Microbiota-Derived Indole-3-Propionic Acid”，展示了植酸通过微生物代谢产物改善皮肤屏障功能的新发现。首都医科大学附属北京儿童医院的王珊博士分享了“Microbial metabolite hypoxanthine attenuates atopic dermatitis-like symptoms”，探讨了微生物代谢产物次黄嘌呤对特应性皮炎样症状的缓解作用。同济大学附属皮肤病医院的过卓霖博士汇报了“Periostin-Expressing Dermal Preadipocytes Amplify Type-2 Inflammation by Guiding Th2 Cell Chemotaxis and Adhesion in Atopic Dermatitis”，揭示了骨膜素在特应性皮炎2型炎症中的新机制。安徽医科大学附属第一医院的王振祥博士带来了“Analysis of Serum Short-Chain Fatty Acids in Pediatric Patients with Atopic Dermatitis Using UHPLC-MS/MS”，采用先进检测技术分析了特应性皮炎患儿的血清短链脂肪酸谱。最后，同济大学附属上海市第十人民医院的佘晓敏博士以“Role and Mechanisms of the Purinergic Receptor P2RY6 in Regulating Immune Responses in Atopic Dermatitis”为题，深入解析了嘌呤受体P2RY6在特应性皮炎免疫调控中的作用机制。本场会议内容涵盖特应性皮炎、银屑病、皮肤肿瘤、病毒性皮肤病等多个重要领域，10位讲者依次登台，从分子机制到临床实践，从传统治疗到前沿探索，呈现了一场内容丰富、层次分明的学术盛宴，为与会代表提供了宝贵的科研思路与临床借鉴。 11月1日上午 VIP厅中华医学会第九届皮肤科实验研究学术会议（CSID）General Topics 2”专场 2025年11月1日8:00-9:50，CSID 2025“General Topics 2”专场在三楼VIP厅举办，由北京大学第一医院汪旸教授、山东大学齐鲁医院李颖教授共同主持，聚焦皮肤病诊疗机制、中西医协同、新型感染等前沿方向。上海交通大学医学院附属瑞金医院潘萌教授讲述“Exploring the lesional microenvironment in pemphigus”，为揭示天疱疮发病机制及靶向干预提供新视角。石河子大学第一附属医院曾佳教授讲述“Harnessing the Synergy of Traditional Chinese and Western Medicine in Dermatological Diagnosis and Treatment: Sharing a Collective Medical Heritage”，分享中西医结合在皮肤病诊断、治疗中的实践经验。复旦大学附属华东医院石磊博士讲述“Paracrine Senescence Promotes Neutrophil Swarming in ALA-PDT for Viral Warts”，解析ALA光动力治疗病毒疣的机制。昆明医科大学第一附属医院吴文娟博士讲述“A New Perspective on Acne Inflammation: Reprogramming of Arachidonic Acid Metabolism towards LTB₄”，从代谢角度切入，为痤疮抗炎治疗提供新靶点思路。山东第一医科大学附属皮肤病医院糜自豪博士讲述“Excessive Glycine Loop Variations in the Keratin 10 Tail Domain and Implications for Skin Fragility”，为遗传性皮肤病（如皮肤脆性相关疾病）的致病机制研究提供依据。西安交通大学第二医院Kaminsin Jutamas博士讲述“Analysis of HER2 immunohistochemistry Predicts Disease Progression in Extramammary Paget's disease”，探讨HER2蛋白表达与乳腺外Paget病进展的相关性。上海交通大学医学院附属仁济医院徐心怡博士讲述“Targeting IL-17A and IL-36R in Hidradenitis Suppurativa: Insights from a 3D-SeboSkin Model”，探索靶向IL-17A与IL-36R的治疗HS。上海市皮肤病医院刘沛博士讲述“The Role of Macrophage Function Regulation in Photodynamic Therapy for Acne”，阐述痤疮光动力治疗中巨噬细胞功能的变化及调控机制。四川省医科学院·四川省人民医院（电子科技大学附属医院）赵可欣博士讲述“An Overlooked Zoonosis: A Human Case of Bovine Papular Stomatitis Virus Infection”，报告感染牛丘疹性口炎病毒的临床案例。排版 | 星星更多精彩，尽在新版优麦医生APP

临床研究

2025-10-30

·今日头条

玫瑰痤疮治疗十大误区，正在悄悄影响你的临床疗效！

*仅供医学专业人士阅读参考全面梳理近年治疗新进展，助你避开这些坑撰文 | 常怡勇玫瑰痤疮作为一种常见的慢性炎症性皮肤病，其治疗一直是皮肤科临床工作中的难点。尽管治疗方法不断更新，但仍有许多患者面临治疗效果不佳、反复发作的困境。这背后，是否隐藏着一些容易被忽视的治疗误区？本文结合近年国内外最新研究证据，梳理出玫瑰痤疮治疗的十大常见误区，帮助临床医生优化治疗方案，提高治疗效果。误区一：忽视抗微生物药物剂型创新，影响患者依从性传统抗微生物药物治疗虽有效，但常因不良反应导致患者依从性差。近年来，新型剂型的开发为解决这一问题提供了新思路。如1.5%米诺环素泡沫剂通过优化给药方式，显著降低了皮肤刺激性，同时提高了药物生物利用度 [1] 。微囊化过氧化苯甲酰（BPO）采用二氧化硅微胶囊技术，形成可渗透屏障控制药物释放速度，既保留了BPO的抗菌效果，又显著减少了红斑、刺痛等不良反应 [2] 。这些新型剂型为长期治疗提供了更好的选择。表1：抗微生物药物剂型选择误区与纠正误区二：低估血管活性药物的治疗潜力玫瑰痤疮的血管功能异常是核心发病机制之一，但临床医生往往只关注抗炎治疗而忽视血管活性药物的调节作用。除了常用的溴莫尼定和羟甲唑啉外，0.5%噻吗洛尔（timolol）温敏凝胶对毛细血管扩张和红斑的改善率分别达到50%和41.38% [4] 。羟钴胺素作为一氧化氮合酶抑制剂，通过抑制NO诱发的血管舒张，能在注射后1小时内迅速缓解红斑，效果维持2～6天 [5] 。这些血管活性药物为快速控制症状提供了新选择。表2：血管活性药物应用误区与纠正误区三：忽略抗疟药的免疫调节作用羟氯喹（HCQ）通过抑制肥大细胞膜蛋白酶表达和钙激活钾离子通道，有效抑制肥大细胞激活和脱颗粒 [6] 。一项多中心临床研究显示，HCQ（200mg bid）与多西环素（100mg qd）治疗8周疗效相当，但安全性更优 [7] 。这使HCQ成为抗生素的重要替代选择，尤其适用于不能耐受抗生素或不适合长期使用抗生素的患者。表3：抗疟药应用误区与纠正误区四：忽视植物提取物的抗炎抗氧化价值天然植物提取物如青蒿素（ART）和石斛多糖（DOP）具有多重抗炎机制。ART能抑制CD4 + T细胞、中性粒细胞和巨噬细胞浸润，同时抑制LL-37诱导的NF-κB信号通路激活 [8] 。临床研究显示，1%ART乳剂治疗4周后丘疹脓疱改善优于甲硝唑 [9] 。 DOP则通过抑制NF-κB激活和清除氧自由基发挥抗氧化作用，在动物模型中显示良好效果 [10] 。这些植物成分为不耐受传统药物的患者提供了新选择。表4：植物提取物应用误区与纠正误区五：未充分利用JAK抑制剂的免疫调节潜力 JAK/STAT信号通路与TLR2信号传导和氧化应激系统交叉，在玫瑰痤疮炎症过程中起关键作用 [11] 。托法替布作为JAK抑制剂，在临床研究中显示对红斑毛细血管扩张型玫瑰痤疮（ETR）和丘疹脓疱型玫瑰痤疮（PPR）均有显著效果 [12] 。高选择性JAK抑制剂阿布昔替尼也在治疗肉芽肿性玫瑰痤疮中显示出良好效果 [13] 。这类药物为难治性玫瑰痤疮提供了新的治疗方向。表5：JAK抑制剂应用误区与纠正误区六：低估生物制剂在Th17通路中的作用玫瑰痤疮患者皮肤中Th17活性及IL-17水平显著升高，提示IL-17可能是重要治疗靶点 [14] 。司库奇尤单抗作为抗IL-17单克隆抗体，在中重度PPR治疗中显示能显著减少炎性丘疹数量 [15] 。虽然目前证据仍有限，但对于传统治疗无效的严重病例，生物制剂提供了新的希望。表6：生物制剂应用误区与纠正误区七：忽视氨甲环酸的多机制治疗价值氨甲环酸（TXA）不仅具有抑制纤溶酶的作用，还能降低先天免疫相关基因（TLR3、KLK3、Camp）表达，抑制LL-37诱导的CD4+T细胞浸润，降低白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）和基质金属蛋白酶-9（MMP-9）表达，并通过减少CD31+细胞数量和下调血管内皮生长因子（VEGF）表达抑制血管生成 [16] 。临床研究显示，局部外用、口服或皮内注射TXA对ETR均有较好疗效 [17-19] 。表7：氨甲环酸应用误区与纠正误区八：忽视光电治疗的深度与联合应用光电治疗可通过多种机制改善玫瑰痤疮症状。非绝缘微针射频能直接作用于深部血管，减少血管数量 [20] ；577nm近黄光激光具有高血红蛋白吸收率，可减少蠕形螨定植 [21] ；5-氨基乙酰丙酸光动力疗法（ALA-PDT）通过产生自由基抑制微生物生长和调节炎症 [22] ；超声治疗则能抑制MMPs过表达发挥抗炎作用 [23] 。联合光电治疗与药物可提高疗效。表8：光电治疗应用误区与纠正误区九：忽略肉毒毒素和PRP的注射治疗价值肉毒毒素（BTX）通过阻断乙酰胆碱释放减少神经源性炎症，同时抑制P物质和降钙素基因相关肽（CGRP）释放 [24] 。研究还表明BTX可抑制肥大细胞脱颗粒，缓解玫瑰痤疮样炎症 [25] 。富血小板血浆（PRP）则通过破坏NF-κB信号传导，抑制COX-1、COX-2和PGE2产生发挥抗炎作用 [26] 。这些注射治疗为顽固性病例提供了新选择。表9：注射治疗应用误区与纠正误区十：忽视膳食干预的辅助治疗价值饮食模式如地中海饮食（MD）和N-3多不饱和脂肪酸（PUFAs）补充可通过抗炎、调节肠道菌群等机制改善玫瑰痤疮。前瞻性研究显示，坚持MD程度与玫瑰痤疮发生风险呈负相关 [27] 。N-3 PUFAs能下调TNF-α、IL-1β和IL-6的mRNA水平，抑制中性粒细胞浸润和肥大细胞脱颗粒，通过下调TLR2/MyD88/NF-κB通路抑制皮肤炎症 [28] 。表10：膳食干预应用误区与纠正结语玫瑰痤疮治疗已进入多靶点、个体化时代。临床医生应充分了解各种治疗手段的作用机制和适用范围，避免陷入单纯依靠传统方法单一治疗的误区。通过结合新型药物、光电技术、注射治疗和膳食干预等多维度手段，为患者制定全面、个体化的治疗方案，才能提高治疗效果，减少复发风险。参考文献： [1] Gold LS, Del Rosso JQ, Kircik L, et al. Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials. J Am Acad Dermatol. 2020;82(5):1166-1173. [2] Bhatia ND, Werschler WP, Baldwin H, et al. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase Ⅲ, Randomized, Vehicle-Controlled Trials. J Clin Aesthet Dermatol. 2023;16(8):34-40. [3] Jones TM, Stuart I. Safety and Pharmacokinetics of FMX103 (1.5% Minocycline Topical Foam) in Subjects with Moderate-to-Severe Papulopustular Rosacea under Maximum-use Treatment Conditions. J Clin Aesthet Dermatol. 2021;14(3):E53-E57. [4] Tsai J, Chien AL, Kim N, et al. Topical Timolol 0.5% Gel-Forming Solution for Erythema in Rosacea: A Quantitative, Split-Face, Randomized, and Rater-Masked Pilot Clinical Trial. J Am Acad Dermatol. 2021;85(4):1044-1046. [5] Huang YW, Huang HP, Hsu CK, et al. Hydroxocobalamin: An Effective Treatment for Flushing and Persistent Erythema in Rosacea. J Clin Aesthet Dermatol. 2022;15(6):42-45. [6] Li J, Yuan X, Tang Y, et al. Hydroxychloroquine is a novel therapeutic approach for rosacea. Int Immunopharmacol. 2020;79:106178. [7] Wang B, Yuan X, Huang X, et al. Efficacy and safety of hydroxychloroquine for treatment of patients with rosacea: A multicenter, randomized, double-blind, double-dummy, pilot study. J Am Acad Dermatol. 2021;84(2):543-545. [8] Yuan X, Li J, Li Y, et al. Artemisinin, a potential option to inhibit inflammation and angiogenesis in rosacea. Biomed Pharmacother. 2019;117:109181. [9] Wang GJ, Gao XY, Wu Y, et al. Evaluation of the efficacy and tolerance of artemether emulsion for the treatment of papulopustular rosacea: a randomized pilot study. J Dermatolog Treat. 2019;30(8):809-812. [10] Zeng B, Yang Z, Jiang G, et al. Dendrobium polysaccharide (DOP) ameliorates the LL-37-induced rosacea by inhibiting NF-κB activation in a mouse model. Skin Res Technol. 2024;30(1):e13543. [11] Awad SM, Tawfik YM, El-Mokhtar MA, et al. Activation of Janus kinase signaling pathway in acne lesions. Dermatol Ther. 2021;34(1):e14563. [12] Sun YH, Man XY, Xuan XY, et al. Tofacitinib for the treatment of erythematoelangiectatic and papulopustular rosacea: A retrospective case series. Dermatol Ther. 2022;35(11):e15848. [13] Ren M, Yang X, Teng Y, et al. Successful Treatment of Granulomatous Rosacea by JAK Inhibitor Abrocitinib: A Case Report. Clin Cosmet Investig Dermatol. 2023;16:3369-3374. [14] Buhl T, Sulk M, Nowak P, et al. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015;135(9):2198-2208. [15] Kumar AM, Chiou AS, Shih YH, et al. An exploratory, open-label, investigator-initiated study of interleukin-17 blockade in patients with moderate-to-severe papulopustular rosacea. Br J Dermatol. 2020;183(5):942-943. [16] Li Y, Xie H, Deng Z, et al. Tranexamic acid ameliorates rosacea symptoms through regulating immune response and angiogenesis. Int Immunopharmacol. 2019;67:326-334. [17] Bagcorgou F, Vasalou V, Tranetakou V, et al. The new therapeutic choice of tranexamic acid solution in treatment of erythematoelangiectatic rosacea. J Cosmet Dermatol. 2019;18(2):563-567. [18] Jakhar D, Kaur I, Misri R. Topical 10% tranexamic acid for erythematoelangiectatic steroid-induced rosacea. J Am Acad Dermatol. 2022;86(1):e1–e2. [19] Daadaa N, Liaien N, Karray M, et al. Intradermal tranexamic acid microinjections: a novel treatment option for erythematoelangiectatic rosacea. J Cosmet Dermatol. 2021;20(10):3324-3329. [20] Wang B, Deng YX, Li PY, et al. Efficacy and safety of non-insulated fractional microneedle radiofrequency for treating difficult-to-treat rosacea; a 48-week, prospective, observational study. Arch Dermatol Res. 2022;314(7):643-650. [21] Temiz SA, Durmaz K, Isik B, et al. The effect of 577-nm pro-yellow laser on demodex density in patients with rosacea. J Cosmet Dermatol. 2022;21(1):242-246. [22] Sun Y, Chen L, Zhang Y, et al. Topical photodynamic therapy with 5-aminolevulinic acid in Chinese patients with Rosacea. J Cosmet Laser Ther. 2019;21(4):196-200. [23] Schlessinger J, Lupin M, McDaniel D, et al. Safety and Effectiveness of Microfocused Ultrasound for Treating Erythematoelangiectatic Rosacea. J Drugs Dermatol. 2019;18(6):522. [24] 刘乙萱,姜沛斌, 刘静伟, 等. 玫瑰痤疮神经源性炎症及肉毒素治疗相关机制的研究进展. 中华皮肤科杂志, 2022, 55(6):552–554. [25] Choi JE, Werbel T, Wang Z, et al. Botulinum toxin blocks mast cells and prevents rosacea like inflammation. J Dermatol Sci. 2019;93(1):58-64. [26] Ghoz MT, Mohamed DA, Ibrahim ZA, et al. Evaluation of the efficacy and safety of platelet rich plasma injection in treatment of rosacea. Dermatol Ther. 2021;34(5):e15049. [27] Chen P, Yang Z, Fan Z, et al. Associations of adherence to Mediterranean-like diet pattern with incident rosacea: A prospective cohort study of government employees in China. Front Nutr. 2023;10:1092781. [28] Shen S, Yan G, Cao Y, et al. Dietary supplementation of n-3 PUFAs ameliorates LL37-induced rosacea-like skin inflammation via inhibition of TLR2/MyD88/NF-κB pathway. Biomed Pharmacother. 2023;157:114091. 责任编辑：大晨 *"医学界"力求所发表内容专业、可靠，但不对内容的准确性做出承诺；请相关各方在采用或以此作为决策依据时另行核查。

临床研究微生物疗法临床结果

2025-10-24

·GlobeNewswire-Health Care

Biofrontera Inc. Closes Purchase of All Ameluz® and RhodoLED® US Assets from Biofrontera AG

Biofrontera Inc. acquires full U.S. rights to Ameluz® and RhodoLED®, including New Drug Application and associated patents, from former parent Biofrontera AG. New earnout structure reduces payment rate to 12%–15% of U.S. net sales from 25%–35%. Closing releases final $2.5 million of $11 million financing led by existing investors Rosalind Advisors and AIGH Capital Management, which is expected to fund Biofrontera Inc. to profitability. Oct. 23, 2025 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz® and RhodoLED®, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights and contracts, all intellectual property, and related personnel. As a result of the transaction, Biofrontera Inc. will now pay a monthly earnout of 12% in years where annual U.S. net sales of Ameluz® are up to $65 million, and 15% in years where U.S. net sales are above that threshold. These payments will cease upon patent expiry. This replaces the prior transfer-pricing model under which the Company paid perpetual 25%–35% of net sales per tube, depending on timing and indication. The new structure reduces overall cost for Biofrontera Inc. and is expected to accelerate the Company’s timeframe to reach break-even. With the completion of this agreement, Biofrontera Inc. now assumes full responsibility for manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz® and the RhodoLED® portfolio in the U.S. The Company expects the full transfer of assets and personnel to be completed by late Q4 2025 or early Q1 2026. The transaction was funded through an $11 million investment led by existing investors Rosalind Advisors, Inc. and AIGH Capital Management LLC, $8.5 million of which was funded at the time of term-sheet execution. As part of the transaction, Biofrontera AG has received a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the two entities. “This is a transformative transaction that strengthens Biofrontera’s financial and operational profile,” said Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “The significantly reduced earnout structure is expected to drive meaningful gross margin expansion starting in the fourth quarter of 2025. Coupled with the new capital infusion, this positions us to accelerate Ameluz® growth and advance label expansion into additional indications.” Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. The content above comes from the network. if any infringement, please contact us to modify.

引进/卖出

100 项与盐酸氨酮戊酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02908	盐酸氨酮戊酸	L01XD04	DB00855

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
浸润性膀胱癌	日本	SBI Pharmaceuticals Co., Ltd.	2017-09-27
多形性胶质母细胞瘤	澳大利亚	Specialised Therapeutics Glio Pty Ltd	2013-11-07
造影剂	日本	Nobelpharma Co., Ltd.	2013-03-25
基底细胞癌	欧盟	Biofrontera Bioscience GmbH	2011-12-13
基底细胞癌	冰岛	Biofrontera Bioscience GmbH	2011-12-13
基底细胞癌	列支敦士登	Biofrontera Bioscience GmbH	2011-12-13
基底细胞癌	挪威	Biofrontera Bioscience GmbH	2011-12-13
胶质瘤	欧盟	Photonamic GmbH & Co. KG	2007-09-07
胶质瘤	冰岛	Photonamic GmbH & Co. KG	2007-09-07
胶质瘤	列支敦士登	Photonamic GmbH & Co. KG	2007-09-07
胶质瘤	挪威	Photonamic GmbH & Co. KG	2007-09-07
尖锐湿疣	中国	上海复旦张江生物医药股份有限公司	2007-02-14
光化性角化病	美国	Sun Pharmaceutical Industries, Inc.	1999-12-03

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	临床3期	中国	上海复旦张江生物医药股份有限公司	2025-03-11
卵巢上皮癌	临床3期	美国	NX Development Corp.	2024-05-30
复发性卵巢癌	临床3期	美国	NX Development Corp.	2024-05-30
腺样囊性癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
乳腺癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
乳腺导管癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
恶性上皮肿瘤	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
导管癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
乳腺浸润性小叶癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27
粘液性乳腺癌	临床3期	美国	Sbi Alapharma Canada, Inc.	2021-04-27

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06027619 (CTgov)	临床2期	疼痛 \| 光化性角化病	30	Red light illumination+Topical aminolevulinate (10% ALA gel) (Regimen A)	憲簾壓觸觸蓋遞鏇憲願 = 鹽窪蓋構繭憲廠網醖艱築齋鹹鹽顧簾遞觸憲範 (壓願蓋淵鑰網築廠鏇築, 壓壓淵簾齋選襯淵襯築 ~ 鹽糧餘獵遞製觸餘選壓) 更多	-	2025-10-23
				Red light illumination+Topical aminolevulinate (10% ALA gel) (Regimen B)	憲簾壓觸觸蓋遞鏇憲願 = 壓蓋夢廠顧築夢窪淵膚築齋鹹鹽顧簾遞觸憲範 (壓願蓋淵鑰網築廠鏇築, 醖淵鏇築網廠繭積餘築 ~ 齋構淵築蓋廠襯醖衊構) 更多
NCT04815083 (CTgov)	临床3期	乳腺导管癌 \| 导管癌 \| 乳腺浸润性小叶癌 ... 更多	57	PD G 506 A	衊窪膚糧鹽鹽鬱製夢糧(壓醖範壓窪鏇選繭鏇淵) = 襯願鹽膚憲窪選衊膚窪蓋範蓋願餘窪壓糧鑰網 (壓築廠醖淵壓膚選蓋範, 簾糧鑰淵簾網獵艱築築 ~ 窪繭製鏇齋壓蓋蓋鹹鏇) 更多	-	2025-09-03
NCT05101798 (CTgov)	临床2期	颅底肿瘤 \| 头颈部肿瘤	7	5-Aminolevulinic acid Hydrochloride	簾顧鹹窪顧艱獵艱選範 = 獵衊襯鬱構醖艱顧憲製顧觸築範糧襯餘顧鏇憲 (鏇淵製餘獵選膚範製餘, 壓觸構膚餘膚憲網繭簾 ~ 衊鏇艱襯積膚鬱鬱願選) 更多	-	2025-07-28
NCT03573401 (ALA-BCC-CT013, CTgov)	临床3期	浅表型基底细胞癌	187	ALA (BF-200 ALA)	糧簾繭廠積餘築選鹽餘 = 獵願願鏇構積蓋衊觸積鑰廠鬱餘衊壓糧夢膚選 (構製窪願淵糧築艱齋醖, 鹹壓窪顧築襯艱觸網鑰 ~ 遞築範淵蓋範齋顧選鏇) 更多	-	2025-04-29
				Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient) (Vehicle)	糧簾繭廠積餘築選鹽餘 = 憲觸艱製鏇餘網窪鬱壓鑰廠鬱餘衊壓糧夢膚選 (構製窪願淵糧築艱齋醖, 夢鹽網選簾獵鹽餘淵艱 ~ 網膚鑰簾簾淵蓋餘膚憲) 更多
NCT01128218 (Phase 2 Sensitivity and Selectivity Study, Pubmed \| Oper Neurosurg (Hagerstown))	临床2期	复发性胶质母细胞瘤	31	High-dose 5-ALA (>40 mg/kg)	夢齋鹽構繭積鹹醖淵鹽(壓積窪繭鹹襯壓壓獵觸) = 構顧糧選製齋淵夢獵製鹽獵夢壓選網衊願淵網 (齋廠築廠鬱鏇壓糧鬱鏇 ) 更多	积极	2024-11-11
				Low/standard dose 5-ALA (<30 mg/kg)	夢齋鹽構繭積鹹醖淵鹽(壓積窪繭鹹襯壓壓獵觸) = 廠範襯夢製餘選顧醖壓鹽獵夢壓選網衊願淵網 (齋廠築廠鬱鏇壓糧鬱鏇 ) 更多
TMOD-04 (SNO2024)	临床1期	-	8	Sonodynamic Therapy with 5-ALA HCL Oral Solution and CV-01	壓壓簾繭願顧遞膚衊鏇(糧壓選蓋鏇顧繭積窪鹽) = 糧膚夢蓋鏇構廠鬱醖遞壓夢餘獵廠糧獵鬱鏇簾 (憲鬱窪夢鬱觸鏇觸夢鹽 )	积极	2024-11-11
				5-ALA HCL oral solution (Control Group)	壓壓簾繭願顧遞膚衊鏇(糧壓選蓋鏇顧繭積窪鹽) = 衊窪窪淵遞構獵鹽願積壓夢餘獵廠糧獵鬱鏇簾 (憲鬱窪夢鬱觸鏇觸夢鹽 )
NCT03573401 (ALA-BCC-CT013, GlobeNewswire) 人工标引	临床3期	基底细胞癌	187	Ameluz®-PDT	構顧選膚簾遞構繭網獵(膚衊製繭齋襯範鏇衊夢) = 廠願獵鏇顧願壓糧築顧鏇遞繭網艱鬱鏇糧選醖 (鑰願壓顧網鹹鑰鹹繭範 ) 更多	积极	2024-10-31
				Placebo-PDT	構顧選膚簾遞構繭網獵(膚衊製繭齋襯範鏇衊夢) = 壓鑰艱艱構鹽簾齋網蓋鏇遞繭網艱鬱鏇糧選醖 (鑰願壓顧網鹹鑰鹹繭範 ) 更多
P18.53.A (EANO2024)	N/A	胶质母细胞瘤辅助 5-aminolevulinic acid (5-ALA) positive	23	5-aminolevulinic acid (5-ALA) (No residual 5-ALA)	繭蓋遞鏇廠淵選鬱壓繭(鏇廠鏇淵鏇夢鹽齋襯顧) = 蓋餘製鏇衊觸範顧範艱憲範襯廠蓋襯獵顧簾壓 (鹽衊蓋築淵鹹齋憲廠壓 ) 更多	不佳	2024-10-17
				5-aminolevulinic acid (5-ALA) (Focal residual 5-ALA)	繭蓋遞鏇廠淵選鬱壓繭(鏇廠鏇淵鏇夢鹽齋襯顧) = 醖遞積鬱繭鏇製窪簾膚憲範襯廠蓋襯獵顧簾壓 (鹽衊蓋築淵鹹齋憲廠壓 ) 更多
NCT05060237 (CTgov)	临床1期	光化性角化病	112	5-ALA (5-aminolevulinic acid)	壓窪網網觸網觸窪窪願 = 築鑰壓餘憲築製鑰壓餘壓觸顧蓋襯糧鬱衊簾膚 (構壓顧衊鑰餘網廠餘淵, 廠觸夢網淵淵願鬱糧製 ~ 醖鹽鹽築鹹鬱糧鏇鏇艱) 更多	-	2024-10-17
NCT03048240 (INDYGO, Pubmed \| J Neurooncol)	N/A	胶质母细胞瘤 5-aminolevulinic acid hydrochloride (5-ALA HCl)	-	Intraoperative photodynamic therapy (PDT) with 5-aminolevulinic acid hydrochloride (5-ALA HCl)	齋獵憲夢夢構鹽鏇選衊(構繭鬱餘鑰築憲淵範顧) = 憲膚遞壓糧選憲憲膚網壓鏇蓋廠膚範艱繭鏇構 (顧鹽淵膚醖鹽夢遞網糧 ) 更多	积极	2024-07-01