A Multicenter, Randomised, Double Blind, Placebo-controlled Study of Efficacy, Safety, and Tolerability of Kaprolac® K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population.
In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE.
The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.

开始日期2008-02-01

申办/合作机构

Moberg Pharma AB

EUCTR2007-006188-59-SE / Not yet recruitingN/A

A multicenter, randomised double blind, placebo-controlled study of efficacy, safety and tolerability of Kaprolac® K301 for the treatment of seborrhoeic eczema (SE) of the scalp.

开始日期2008-01-14

申办/合作机构-

EUCTR2006-005242-36-SE / Not yet recruitingN/A

A multicenter, randomised, double-blind, placebo-controlled clinical study evaluating efficacy, safety and tolerability of topical K40 in 8 weeks treatment of adult patients with moderate to severe intensity of seborrhoeic dermatitis in the scalp

开始日期2006-12-13

申办/合作机构-

100 项与 K-301 相关的临床结果

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项与 K-301 相关的文献（医药）

2021-06-01·Applied Radiation and Isotopes3区 · 工程技术

Committed effective dose and lifetime cancer risk due to ingestion of natural radionuclides in grains grown in an area of high background radiation

3区 · 工程技术

Article

作者: Talhofer, Jardel L ; Lopes, José M ; Silva, Ademir X ; Silva, Leandro B ; Garcêz, Ricardo W D ; Pereira, Wagner S

The current study aimed at estimating committed effective dose and cancer risk due to the intake of K-40, Ra-226, Ra-228 and Th-228 present in grains grown in an HBRA. The highest activity concentrations found were (606.2 ± 25.13), (8.07 ± 6.37), (10.01 ± 1.45), (43.97 ± 5.54) Bq.kg^-1 for K-40, Ra-226, Ra-228 and Th-228, respectively. The committed effective dose estimated was 0.5 mSv.y^-1, and the estimated cancer risk suggested that uninterrupted and unrestricted consumption of beans grown in this HBRA is not desirable.

2013-11-01·Bulletin of Environmental Contamination and Toxicology4区 · 环境科学与生态学

Radioactivity of Honeys from Poland After the Fukushima Accident

4区 · 环境科学与生态学

Article

作者: Jacek Kapała ; Anna Puścion-Jakubik ; Justyna Horembała ; Renata Markiewicz-Żukowska ; Maria H. Borawska

Concentration of radioactive isotopes in honey constitutes an important bioindicator of environmental radiation. One hundred six honey samples were collected from hives and from bottled honey provided by beekeepers from north-eastern Poland in 2010, before the Fukushima accident, and during the two-year period directly following this catastrophe (2011-2012). Cesium-137 (Cs-137) and potassium-40 (K-40) were determined in lime, multifloral, buckwheat, honeydew and other kinds of honey samples. The obtained mean concentrations of Cs-137 and K-40 (Bq kg(-1)) in honey samples were: 1.19 and 32.92 in 2010, 0.90 and 31.13 in 2011, 1.31 and 36.06 in 2012, respectively. Significant differences were not observed. Therefore, the studied honey samples collected after the Fukushima accident are found to be safe for humans with levels of Cs-137 and K-40 not posing any threats. However, the total concentration of Cs-137 and K-40 in samples stopped decreasing in 2010-2011 and showed a slight increase in 2012. This relation may suggest the impact of pollution from Fukushima and requires further research in the coming years.

2012-09-01·Mycoses2区 · 医学

Treatment of seborrhoeic dermatitis of the scalp with a topical solution of urea, lactic acid, and propylene glycol (K301): results of two double‐blind, randomised, placebo‐controlled studies

2区 · 医学

Article

作者: Åke Svensson ; Lennart Emtestam ; Kjell Rensfeldt

Summary Alternative treatments for seborrhoeic dermatitis are needed because of the increasing risk of anti‐fungal resistance to existing therapies. To investigate the efficacy, safety and tolerability of topical scalp treatment with K301 solution. Two multi‐centre, randomised, double‐blind studies were conducted. Study I: 4 weeks of once‐daily treatment with either one form of K301 (a or b) or placebo, followed by 4 weeks of maintenance treatment three times‐per‐week. Study II: 4 weeks of K301 (a) or placebo once‐daily. Study I: 98 patients enrolled (K301a + b, n = 51; placebo, n = 47) and 83 completed; 201 entered Study II (K301a, n = 136; placebo, n = 65) and 195 completed. Erythema and desquamation sum score at 4 weeks, mean (SD) values were 2.4 (2.0) for K301a + b and 3.2 (2.2) for placebo in Study I (P = 0.025) and 2.5 (1.9) for K301a and 3.2 (1.8) for placebo in Study II (not significant). In both studies, 4‐week desquamation scores were significantly improved for K301 vs. placebo (P < 0.05). Both studies showed significant improvements in symptomatic investigator and patient assessments for K301 over placebo after 4 weeks (P < 0.05). Treatment‐related adverse events were generally mild and included some smarting or burning upon application. The K301 was well tolerated and associated with clinically meaningful improvements in seborrhoeic dermatitis endpoints.

项与 K-301 相关的新闻（医药）

2024-08-04

·生物探索

Sci Adv丨吴允昆/郑清炳等解析不同噬菌体蛋白调节细菌DSR2抗噬菌体防御系统NADase活性的机制

引言噬菌体通过特异性感染宿主细菌实现自身的生长和繁殖。面对噬菌体的频繁攻击，细菌不断斗争并进化出系列复杂且精妙的防御策略。近年来，随着细菌防御岛的发现，许多新型细菌防御系统被挖掘。dsr2基因家族即是在枯草芽孢杆菌29R菌株中通过防御岛鉴定出来的，其编码的DSR2蛋白N端含有沉默信息调节因子2（SIR2）结构域【1】。一些SIR2家族蛋白可以直接消耗细菌体内NAD+引起生长停滞，从而抵御噬菌体感染【2】。枯草芽孢杆菌利用DSR2蛋白识别噬菌体SPR尾管蛋白（TTP），激活DSR2的NADase活性，保护细菌免受噬菌体的侵染。针对细菌的这种防御，噬菌体SPbeta/phi3T编码抗DSR2蛋白（DSAD1），结合DSR2并抑制其NADase活性来逃避该防御机制【3】。尽管DSR2在抗噬菌体防御中的作用已被证实，但DSR2活性调控的分子机制尚不明晰。 2024年7月31日，福建师范大学吴允昆教授团队联合厦门大学郑清炳高级工程师等在Science Advances发表了题为Structural insights into activation mechanisms on NADase of bacterial DSR2 anti-phage defense system的研究论文。该研究利用单颗粒冷冻电镜技术分别解析了apo DSR2、DSR2-TTP复合物和DSR2-DSAD1复合物的结构，并基于结构分析了DSR2 NADase活性调控的分子机制。冷冻电镜结构揭示DSR2呈四聚体组装，两个二聚体（DSR2AB和DSR2CD）以SIR2结构域“头碰头”的方式形成四聚体。结构比对显示在DSR2四聚体中，DSR2单体呈现开放（DSR2open）和关闭（DSR2closed）两种不同的构象。每个DSR2单体包含SIR2（残基1-297）、MID（残基298-627）和CTD（残基628-1005）三个结构域（图 1A-B）。图 1 DSR2及其复合体冷冻电镜结构A: DSR2结构域划分; B: apo DSR2; C: DSR2-TTP; D: DSR2-DSAD1（Credit: Science Advances）生化实验表明单体TTP蛋白，而非聚集状态的TTP，与DSR2结合形成稳定的复合物。DSR2-TTP复合体结构显示DSR2closed形成的结合口袋与TTP更适配，TTP仅与DSR2closed结合（图 1C）。结构分析结合突变及酶活实验可知单体TTP通过诱导DSR2的SIR2结构域四聚化构象变化激活其NADase活性。其中，MID具有将构象变化从CTD传递到SIR2结构域的作用，对于DSR2的NADase活性激活至关重要。相互作用实验分析显示TTP与DSR2closed产生紧密互作的同时，TTP残基K40可与相邻DSR2open残基E633产生氢键和盐桥，拉动DSR2open的α30-31 loop朝TTP的方向移动约8 Å的距离，这可能触发其向DSR2closed状态转变。 DSR2-DSAD1复合体结构表明，DSAD1特异性识别并结合DSR2open（图 1D）。由于空间位阻，DSAD1不结合DSR2closed。DSAD1不仅与DSR2open互作，也与相邻DSR2closed的CTD结构域以及MID结构域形成氢键。酶活实验表明DSAD1的存在竞争性抑制了TTP对DSR2的激活。结构叠合比对显示TTP蛋白和DSAD1蛋白不能占据同一结合口袋。通过微量热泳动实验测定并比较DSAD1和单体TTP与DSR2蛋白的亲和力，结果表明DSAD1对DSR2的亲和力大于TTP，分别为40.4 nm和654.7 nm。基于结构综合分析及生化实验，我们提出了DSAD1抑制调控DSR2系统激活的模型，即DSAD1不仅结合DSR2open，直接占据结合口袋，将DSR2open锁定在非活性状态；还稳定相邻DSR2closed单体的MID，以阻止TTP诱导的SIR2四聚组装构象变化，别构抑制TTP对DSR2 NADase活性的激活（图 2）。图 2 TTP和DSAD1调控DSR2活性的机制模型（Credit: Science Advances）综上，本研究基于多结构与功能比较分析，破译了DSR2组装、TTP介导DSR2激活及DSAD1介导DSR2抑制的详细分子机制，提出了DSR2 NADase活性调控的模型，为进一步深入理解细菌免疫中SIR2依赖的NAD+耗竭机制奠定了坚实的基础。参考文献 1. Gao L.Y., Altae-Tran H., Böhning F., et al. Diverse enzymatic activities mediate antiviral immunity in prokaryotes[J]. Science. 2020, 369(6507):1077-1084. 2. Mariano G.,Blower T.R. Conserved domains can be found across distinct phage defence systems[J]. Mol. Microbiol. 2023, 120(1):45-53. 3. Garb J., Lopatina A., Bernheim A., et al. Multiple phage resistance systems inhibit infection via SIR2-dependent NAD(+) depletion[J]. Nat. Microbiol. 2022, 7(11):1849-1856. https://www.science.org/doi/epdf/10.1126/sciadv.adn5691 责编|探索君排版|探索君文章来源|“BioArt” End 往期精选围观一文读透细胞死亡(Cell Death) | 24年Cell重磅综述（长文收藏版）热文 Cell | 是什么决定了细胞的大小？热文 Nature | 2024年值得关注的七项技术热文 Nature | 自身免疫性疾病能被治愈吗？科学家们终于看到了希望热文 CRISPR技术进化史 | 24年Cell综述

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