An Open Label Multi Center Phase III Subject/Caregiver Initiated Safety Study of Xerese(Acyclovir and Hydrocortisone)Cream 5%/1% in the Treatment of Recurrent Herpes Labialis in Children

To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.

开始日期2012-03-01

申办/合作机构

Meda Pharmaceuticals, Inc.

[+1]

NCT00735761

/ Completed临床3期

A Randomized, Double-Blind, Active-Controlled, Subject Initiated Study Comparing ME-609 to Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis in Immunocompromised Patients

The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

开始日期2006-12-01

申办/合作机构

Medivir AB

EUCTR2006-002828-42-SE

/ Not yet recruitingN/A

An open label, multi-centre, phase III, subject initiated safety study of ME-609 in treatment of recurrent herpes simplex labialis in adolescents.

开始日期2006-11-01

申办/合作机构

Medivir AB

100 项与阿昔洛韦/氢化可的松相关的临床结果

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100 项与阿昔洛韦/氢化可的松相关的转化医学

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100 项与阿昔洛韦/氢化可的松相关的专利（医药）

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项与阿昔洛韦/氢化可的松相关的文献（医药）

2013-01-01·Antiviral Agents

Antiviral Agents for Herpes Simplex Virus

Review

作者: Hugh J Field ; R Anthony Vere Hodge

This review starts with a brief description of herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), the clinical diseases they cause, and the continuing clinical need for antiviral chemotherapy. A historical overview describes the progress from the early, rather toxic antivirals to acyclovir (ACV) which led the way for its prodrug, valacyclovir, to penciclovir and its prodrug, famciclovir (FCV). These compounds have been the mainstay of HSV therapy for two decades and have established a remarkable safety record. This review focuses on these compounds, the preclinical studies which reveal potentially important differences, the clinical trials, and the clinical experience through two decades. Some possible areas for further investigation are suggested. The focus shifts to new approaches and novel compounds, in particular, the combination of ACV with hydrocortisone, known as ME609 or zovirax duo, an HSV helicase-primase inhibitor, pritelivir (AIC316), and CMX001, the cidofovir prodrug for treating resistant HSV infection in immunocompromised patients. Letermovir has established that the human cytomegalovirus terminase enzyme is a valid target and that similar compounds could be sought for HSV. We discuss the difficulties facing the progression of new compounds. In our concluding remarks, we summarize the present situation including a discussion on the reclassification of FCV from prescription-only to pharmacist-controlled for herpes labialis in New Zealand in 2010; should this be repeated more widely? We conclude that HSV research is emerging from a quiescent phase.

2011-04-01·Journal of the American Academy of Dermatology1区 · 医学

Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: A randomized, double-blind, placebo-controlled, patient-initiated clinical trial

1区 · 医学

Article

作者: Börje Darpö ; Johan Bring ; Eva Arlander ; Christopher M. Hull ; Johan Harmenberg ; Myron J. Levin ; Spotswood L. Spruance ; Stephen Tyring ; Fred Aoki

BACKGROUNDPrior pilot studies support the use of antiviral medications with topical corticosteroids for herpes simplex labialis (HSL). ME-609 (Xerese, Xerclear) is a combination of 5% acyclovir and 1% hydrocortisone developed for the topical treatment of HSL.OBJECTIVESThe primary study end point was the prevention of ulcerative HSL lesions.METHODSIn all, 2437 patients with a history of HSL were randomized to self-initiate treatment with ME-609, 5% acyclovir in ME-609 vehicle, or ME-609 vehicle (placebo) at the earliest sign of a cold sore recurrence. Cream was applied 5 times/d for 5 days. A total of 1443 patients experienced a recurrence and initiated treatment with ME-609 (n = 601), acyclovir (n = 610), or placebo (n = 232).RESULTSOf patients receiving ME-609, 42% did not develop an ulcerative lesion compared with 35% of patients receiving acyclovir in ME-609 vehicle (P = .014) and 26% of patients receiving placebo (P < .0001). In patients with ulcerative lesions, healing times were reduced in the ME-609 and acyclovir groups compared with placebo (P < .01 for both). The cumulative lesion area for all lesions was reduced 50% in patients receiving ME-609 compared with the placebo group (P < .0001). There were no differences among groups in the number of patients with positive herpes simplex virus cultures. The side-effect profile was similar among treatments.LIMITATIONSThe study did not contain a group treated with a topical corticosteroid alone.CONCLUSIONSME-609 prevented progression of cold sores to ulcerative lesions and significantly reduced the cumulative lesion area compared with acyclovir and placebo. ME-609 treatment offers additional therapeutic benefit compared with therapy with topical acyclovir alone.

2010-09-15·Postgraduate Medicine4区 · 医学

The Role of Topical 5% Acyclovir and 1% Hydrocortisone Cream (Xerese™) in the Treatment of Recurrent Herpes Simplex Labialis

4区 · 医学

Review

作者: Hull, Christopher M ; Brunton, Stephen

Recurrent herpes simplex labialis (HSL), also known as orofacial herpes or cold sores, is a common clinical presentation of herpes simplex virus (HSV) infection. It may manifest as painful, distressing, and cosmetically displeasing vesicles on the lips, nose, and nasal septum. Although oral or topical treatment with antiviral agents can reduce the replication of HSV-1, the primary benefits of antiviral therapies for recurrent HSL have been limited to modest reductions in healing time; they do not mitigate the accompanying immune-mediated response of the host to the virus. The addition of a topical corticosteroid to an antiviral cream has been hypothesized to improve the clinical outcome of HSL by decreasing the HSV-related immune-mediated inflammatory skin reaction. A recently developed topical cream containing 5% acyclovir and 1% hydrocortisone (AHC) in a novel cream vehicle has been shown to be safe and effective for the early treatment of recurrent HSL in immunocompetent adult and adolescent patients. In a well-controlled clinical trial, AHC cream significantly reduced the frequency of both ulcerative and nonulcerative recurrences (ie, the prevention of vesicular HSL lesions). Treatment was well tolerated, and there was no evidence of emergence of viral resistance to acyclovir with the addition of hydrocortisone. The AHC cream significantly reduced the recurrence of ulcerative and nonulcerative HSL lesions and shortened healing time with early treatment compared with acyclovir 5% cream and vehicle (placebo) cream. Herpes simplex labialis may not typically be considered a serious medical condition; however, the importance of treating HSL should not be overlooked, considering the continuous increase of the viral pool in the general population and the potential psychological and social consequences of the condition when left untreated.

项与阿昔洛韦/氢化可的松相关的新闻（医药）

2024-08-08

·药通社

高迈药业——专注于外用药的药学研发 | CMC-China博览会展商速递

公司介绍苏州高迈药业有限公司成立于2018年，位于苏州工业园区纳米园；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）；团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批；4个已经申报受理项目；2024年计划申报12个项目。公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。项目清单乳膏/软膏/凝胶类1、利丙双卡因乳膏(已获批)11、维氟醌乳膏(氟轻松氢醌维A酸乳膏)21、磷酸芦可替尼乳膏31、复方多粘菌素B软膏2、阿达帕林凝胶(已注册申报)12、尿素乳膏22、复方倍他米松樟脑乳膏32、盐酸丁卡因凝胶3、夫西地酸乳膏(已注册申报)13、盐酸特比萘芬乳膏23、曲咪新乳膏33、壬二酸凝胶4、过氧苯甲酰凝胶(已注册申报)14、卢立康唑乳膏24、多磺酸粘多糖乳膏34、酮洛芬凝胶5、阿达帕林过氧苯甲凝胶(已注册申报)15、曲安奈德益康唑乳膏25、氟维司群乳膏35、雌二醇凝胶6、盐酸阿莫罗芬乳膏16、布洛芬乳膏26、克霉唑阴道乳膏36、黄体酮阴道缓释凝胶7、硝酸咪康唑乳膏17、阿昔洛韦氢化可的松乳膏27、莫匹罗星软膏37、盐酸利多卡因凝胶8、利多卡因丁卡因乳膏18、氢醌乳膏28、克立硼罗软膏38、硝呋太尔制霉菌素阴道软膏9、克拉司酮乳膏19、糠酸莫米松乳膏29、双唑泰乳膏10、伊维菌素乳膏20、丙酸氟替卡松乳膏30、卡泊三醇软膏贴剂1、利多卡因凝胶贴膏4、双氯芬酸依泊胺贴7、双氯芬酸二乙胺乳胶剂10、美沙拉嗪栓2、双氯芬酸钠贴剂5、洛索洛芬钠凝胶贴膏8、妥洛特罗贴剂11、奥昔布宁透皮贴剂3、氟比洛芬凝胶贴膏6、洛索洛芬钠贴剂9、雌二醇贴片 // 其他 1、非那雄胺喷雾剂 2、盐酸阿莫罗芬搽剂 3、联苯苄唑溶液 4、盐酸特比萘芬喷雾剂 5、盐酸特比萘芬涂膜剂 6、硝酸益康唑气雾剂 7、西甲硅油乳剂 8、利多卡因丙胺卡因气雾剂 9、艾氟康唑外用溶液 10、利多卡因喷雾剂 11、盐酸氨酮戊酸外用散 *绿色标色已经获批 *浅绿色表示已经申报设备及资质联系我们联系人：曹总13861331380 ↓↓扫描下方二维码免费报名

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2024-03-29

·药通社

高迈药业：专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂） | 邀您共赴广州MAH B证企业论坛

2024.4.24 • 中国广州2024MAH B证沙龙展位号：A11号展位分布▼关于高迈药业苏州高迈药业有限公司成立于2018年，即将搬迁至生物医药产业园四期，研发场地面积11000平方米；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）；团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批，2个创新药的临床1期批件，已申报3个产品。公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。项目清单序号项目名称适应症分类1利丙双卡因乳膏局麻2盐酸利多卡因凝胶局麻3盐酸丁卡因凝胶局麻4利多卡因丁卡因乳膏局麻5利多卡因凝胶贴膏局麻6利多卡因喷雾剂局麻7阿达帕林凝胶痤疮8过氧苯甲酰凝胶痤疮9阿达帕林过氧苯甲酰凝胶痤疮10克拉司酮乳膏痤疮11壬二酸凝胶痤疮12夫西地酸乳膏抗感染13莫匹罗星软膏抗感染14伊维菌素乳膏抗感染15复方多粘菌素B软膏抗感染16阿昔洛韦氢化可的松乳膏抗感染17双唑泰乳膏抗感染18盐酸氨酮戊酸外用散抗感染19双氯芬酸二乙胺乳胶剂镇痛20氟比洛芬凝胶贴膏镇痛21双氯芬酸依泊胺贴镇痛22酮洛芬凝胶镇痛23洛索洛芬钠凝胶贴膏镇痛24洛索洛芬钠贴剂镇痛25双氯芬酸钠贴剂镇痛26布洛芬乳膏镇痛27盐酸阿莫罗芬乳膏抗真菌28硝酸咪康唑乳膏抗真菌29盐酸特比萘芬喷雾剂抗真菌30盐酸特比萘芬乳膏抗真菌31盐酸特比萘芬涂膜剂抗真菌32联苯苄唑溶液抗真菌33卢立康唑乳膏抗真菌34曲安奈德益康唑乳膏抗真菌35盐酸阿莫罗芬搽剂抗真菌36艾氟康唑外用溶液抗真菌37硝酸益康唑气雾剂抗真菌38西甲硅油乳剂胀气39利多卡因丙胺卡因气雾剂早泄40卡泊三醇软膏银屑病41非那雄胺喷雾剂脱发42氢醌乳膏黄褐斑43维氟醌乳膏(氟轻松氢醌维A酸乳膏)黄褐斑44尿素乳膏皲裂45妥洛特罗贴剂气管炎46克立硼罗软膏皮炎47糠酸莫米松乳膏皮炎48丙酸氟替卡松乳膏皮炎49磷酸芦可替尼乳膏皮炎50复方倍他米松樟脑乳膏皮炎51曲咪新乳膏皮炎52多磺酸粘多糖乳膏静脉曲张53黄体酮阴道缓释凝胶激素补充54雌二醇凝胶激素补充55雌二醇贴片激素补充56美沙拉嗪栓肠炎57奥昔布宁透皮贴剂膀胱过动58氟维司群乳膏乳腺癌59克霉唑阴道乳膏阴道炎60硝呋太尔制霉菌素阴道软膏阴道炎设备及资质01透皮仪02粘度计联系我们联系人：陈先生 18006207168欢迎扫码报名广州 MAH 沙龙 9:00-9:40132号文新政实施后，如何办B证？药监专家9:40-10:10批文&项目合作路演限时免费报名中10:10-10:40茶歇10:40-11:20B证企业迎接检查注意点及缺陷案例药监专家11:20-12:00MAH制度下集采和医保政策解析许金灿，药闻康策创始人兼总经理12:00-14:00茶歇14:00-14:30药品上市许可持有人变更审批及案例分享药监专家14:30-15:00从欧美MAH监管体系看中国药品制度创新之路杜新，前FDA CMC审评专家，埃格林医药总经理15:00-15:30批文&项目合作路演限时免费报名中15:30-15:50茶歇15:50-16:20B证企业关键人员能力素养要求谢海燕，丽珠集团党委委员、质量管理总部总经理、广东省药学会质量受权人专委会主任委员16:20-16:50新形势下持有人产品立项考量赵忠卫，深圳奥祺生物医药有限公司总经理*议程更新中，以现场为准*报名参会限时免费，食宿自理（联系参会人员参与免费领餐券活动）扫描下方二维码！免费！免费！免费报名

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2024-01-10

·药通社

高迈药业：专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）| 邀您共赴海南MAH B证企业论坛

2024.1.12 • 海南海口【2024 MAH B证企业论坛】苏州高迈药业有限公司成立于2018年，即将搬迁至生物医药产业园四期，研发场地面积11000平方米；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）；团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批，2个创新药的临床1期批件，已申报3个产品。公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。项目清单— 项目名称 — 1利丙双卡因乳膏（已获批） 2阿达帕林凝胶（已注册申报） 3夫西地酸乳膏（已注册申报） 4过氧苯甲酰凝胶（已注册申报） 5阿达帕林过氧苯甲酰凝胶 6克立硼罗软膏 7莫匹罗星软膏 8双氯芬酸二乙胺乳胶剂 9硝酸咪康唑乳膏10盐酸阿莫罗芬乳膏11盐酸特比萘芬乳膏12联苯苄唑溶液13盐酸特比萘芬喷雾剂14利多卡因喷雾剂15盐酸阿莫罗芬搽剂16糠酸莫米松乳膏17艾氟康唑外用溶液18盐酸特比萘芬涂膜剂19盐酸利多卡因凝胶20丙酸氟替卡松乳膏21雌二醇凝胶22雌二醇贴片23非那雄胺喷雾剂24利多卡因喷雾剂25尿素乳膏26卡泊三醇软膏27卢立康唑乳膏28氟比洛芬凝胶贴膏29氟维司群乳膏30复方多粘菌素B软膏31黄体酮阴道缓释凝胶32氟轻松氢醌维A酸乳膏33利多卡因丁卡因乳膏34曲安奈德益康唑乳膏35双氯芬酸钠贴剂36双氯芬酸依泊胺贴37美沙拉秦栓38利多卡因凝胶贴膏39洛索洛芬钠凝胶贴膏40洛索洛芬钠贴剂41阿昔洛韦氢化可的松乳膏42利多卡因丙胺卡因气雾剂43多磺酸粘多糖乳膏44伊维菌素乳膏45盐酸丁卡因凝胶46克霉唑阴道乳膏47布洛芬乳膏48磷酸芦可替尼乳膏49克拉司酮乳膏50氢醌乳膏51曲咪新乳膏52双唑泰乳膏53奥昔布宁透皮贴剂54妥洛特罗贴剂55硝呋太尔制霉菌素阴道软膏56硝酸益康唑喷雾剂57盐酸氨酮戊酸外用散58复方倍氯米松樟脑乳膏59地奈德乳膏60酮洛芬凝胶设备及资质流变仪01透皮仪02粘度计03联系我们联系人：陈先生 18006207168↓↓快速报名通道↓↓▼ 本次会议议程，可上下滑动查看9:00-9:20海南省医药产业政策介绍海南省工业和信息化厅专家09:20-09:50新政实施后，如何办B证？药监专家09:50-10:10茶歇10:10-10:40最新B证监管政策解读药监专家10:40-11:10MAH制度下企业仿制药立项王立峰慧药咨询创始人11:10-11:40批文&项目合作路演11:40-13:30午餐时刻13:30-14:00医改政策盘点及企业应对策略许金灿，药闻康策创始人兼总经理14:00-14:30MAH委托生产-监管政策的解读沈红梅，重庆博腾制药科技股份有限公司制剂研发副总经理、正高级工程师14:30-15:00MAH B证企业经验谈销售型企业转型B证经验谈综合型药企持证委托生产经验谈研发型药企持证经验谈15:00-15:30批文&项目合作路演15:30-15:50茶歇15:50-16:20MAH B证公司迎接检查注意点周鹏程，国家资深GMP检查员16:20-16:50MAH制度下，B证企业委托生产共线风险考量唐老师，国家资深GMP检查员

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100 项与阿昔洛韦/氢化可的松相关的药物交易

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唇疱疹	美国	Bausch Health US LLC	2009-07-31

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唇疱疹	临床1期	韩国	Daewoong Pharmaceutical Co., Ltd.	-

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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


NCT00361881 (Pubmed \| J Am Acad Dermatol)	临床3期	唇疱疹	2,437	ME-609	糧憲選壓壓鬱廠觸壓壓(網醖網夢醖鹽網簾夢構) = 構繭顧齋顧淵選醖觸築鬱願憲艱製遞顧淵淵窪 (淵膚選願願簾鏇鏇願鬱 )	积极	2011-04-01