克林霉素磷酸酯/维A酸(Clindamycin Phosphate/Tretinoin) - 药物靶点：50S subunit x RARα x RARβ2 x RARγ_在研适应症：寻常痤疮_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Veltin、Ziana

靶点

50S subunit x RARα x RARβ2 x RARγ

作用机制

50S subunit抑制剂(50S核糖体亚基抑制剂)、RARα激动剂(维甲酸受体α激动剂)、RARβ2激动剂(维甲酸受体β激动剂)

+ [1]

治疗领域

皮肤和肌肉骨骼疾病

在研适应症

寻常痤疮

非在研适应症-

原研机构

Medicis Pharmaceutical Corp.

在研机构

Almirall LLCBausch Health US LLC

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2006-11-07),

寻常痤疮

最高研发阶段(中国)-

特殊审评-

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结构

分子式C38H62ClN2O10PS

InChIKeyRRZFQNYMUQPMHE-HYEGCIPRSA-N

CAS号337954-93-5

关联

12

项与克林霉素磷酸酯/维A酸相关的临床试验

NCT02731105 / Completed临床4期IIT

Pilot Study of Tolerability and Effectivity Following Application of Two Combination Topical Acne Products Clindamycin 1% and 0.025% Tretinoin Gel (Acnatac® Gel), Adapalen 0,1% and Benzoyl Peroxide 2,5% Gel (Epiduo® Gel)

Study to compare two gels that are used to treat acne vulgaris. It will be compared the tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).

开始日期2015-02-01

申办/合作机构-

CTR20140555 / Completed临床3期

克林霉素磷酸酯维A酸凝胶治疗寻常型痤疮的多中心、随机、研究者盲、阳性药平行对照临床试验

评价浙江万马药业有限公司生产的克林霉素磷酸酯维A酸凝胶治疗寻常型痤疮的有效性及安全性。

开始日期2014-07-21

申办/合作机构

北京嘉林药业股份有限公司

CTR20131489 / Completed临床2期

克林霉素磷酸酯维A酸治疗轻中度寻常痤疮的有效性和安全性的多中心、随机、双盲、阳性药、平行对照临床试验

以复方维A酸凝胶作为对照，评价克林霉素磷酸酯维A酸凝胶治疗寻常痤疮的疗效和安全性。

开始日期2012-03-30

申办/合作机构

重庆医药工业研究院有限责任公司

100 项与克林霉素磷酸酯/维A酸相关的临床结果

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100 项与克林霉素磷酸酯/维A酸相关的转化医学

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100 项与克林霉素磷酸酯/维A酸相关的专利（医药）

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5

项与克林霉素磷酸酯/维A酸相关的文献（医药）

2014-01-01·Journal of drugs in dermatology : JDD

The phototoxic and photoallergy potential of clindamycin phosphate 1.2%/ tretinoin 0.025% gel for facial acne: results of two single-center, evaluator-blinded, randomized, vehicle-controlled phase 1 studies in healthy volunteers.

Article

作者: Murray, John ; Potts, Aaron

BACKGROUNDA fixed-dose combination of clindamycin phosphate 1.2% and tretinoin 0.025% gel (VELTIN® (clindamycin phosphate and tretinoin) 1.2%/0.025% Gel [VELTIN]) (clindamycin/tretinoin gel) is currently available for the once-daily topical treatment of acne.OBJECTIVESTwo-phase I studies were conducted to evaluate the phototoxic and photoallergic potential of clindamycin/tretinoin gel.METHODSStudy 1 (phototoxic) (n=37) and Study 2 (photoallergic) (n=58) were single-center, evaluator-blinded, randomized, vehicle-controlled, phase 1 studies conducted in healthy volunteers. In Study 1, clindamycin/tretinoin gel patches, vehicle gel patches and blank patches (no gel) were applied concurrently for 24 hours to naïve sites. After patch removal, sites were irradiated with 16 joules/cm2 of ultraviolet A light (UVA) then 0.75 minimal erythema dose (MED) of UVA/ultraviolet B light (UVB), the same irradiation protocol followed by 15 joules/cm2 of visible light (VIS), or served as non-irradiated controls. Study 2 examined the effect of repeated drug exposure and involved an induction period (6 repeat phases at the same body sites during which clindamycin/tretinoin gel and vehicle gel patches were applied for 24 hours, removed and sites irradiated with UVB +/- VIS), followed by a rest period (10 to 17 days), then a challenge period that used the protocol described for Study 1. In both studies, inflammatory responses and other cutaneous effects were evaluated at 1, 24, 48, and 72 hours after patch removal.RESULTSNo subject experienced any adverse events in Study 1 (phototoxic). One subject in Study 2 (photoallergic) experienced AEs (diffuse erythema; mild application site irritation at one each of UV/VIS-irradiated clindamycin/tretinoin gel and vehicle gel patch sites) considered definitely related to study product that resulted in discontinuation from the study. Data from Study 1 and the challenge phase from Study 2 showed most subjects had no visible inflammatory reaction to clindamycin/tretinoin gel after irradiation.CONCLUSIONSClindamycin/tretinoin gel has a favorable safety profile following UV/visible irradiation and a low potential for phototoxicity and photoallergenicity.

2010-12-29·The Medical letter on drugs and therapeutics4区 · 医学

Clindamycin-tretinoin (veltin gel) for acne.

4区 · 医学

Review

2007-03-01·SKINmed: Dermatology for the Clinician

Ziana (Clindamycin Phosphate 1.2% and Tretinoin 0.025%)Gel

Article

作者: Gover, Melissa D ; Abramovits, William ; Gupta, Aditya K

100 项与克林霉素磷酸酯/维A酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
寻常痤疮	美国	Bausch Health US LLC	2006-11-07

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01047189 (CTgov)	临床4期	寻常痤疮	26	clindamycin phosphate+Ziana gel+tretinoin (Ziana Gel)	蓋淵壓願遞廠願顧範願(醖範鹽壓糧鏇繭衊鹽艱) = 鏇蓋網蓋獵範顧簾艱鑰齋顧積壓壓襯網艱憲淵 (壓鏇淵製顧鑰廠憲網鹹, 積遞襯艱鏇膚獵艱積襯 ~ 觸網鏇艱夢製憲製醖淵) 更多	-	2011-10-17
				Tretinoin+Clindamycin (Clindamycin Plus Tretinoin Applied Separately)	蓋淵壓願遞廠願顧範願(醖範鹽壓糧鏇繭衊鹽艱) = 鏇鹹範淵鏇襯夢繭鹹積齋顧積壓壓襯網艱憲淵 (壓鏇淵製顧鑰廠憲網鹹, 艱鏇艱觸積壓壓廠範襯 ~ 蓋選遞夢網艱蓋糧鹹顧) 更多
NCT00891982 (CTgov)	临床3期	寻常痤疮	60	CLINDAMYCIN PHOSPHATE/TRETINOIN+Benzoyl Peroxide (CTGel Plus BPO Wash)	製鹽壓廠衊糧廠網簾觸(壓繭獵淵製窪夢積鹹糧) = 遞齋醖製齋衊構積壓製壓網齋顧鬱簾糧選鑰鑰 (糧壓築憲襯網鑰糧遞膚, 衊繭艱簾選夢壓鹹憲觸 ~ 構壓鹽製鏇窪憲鹽廠醖) 更多	-	2011-07-25
				CTGel (CTGel)	製鹽壓廠衊糧廠網簾觸(壓繭獵淵製窪夢積鹹糧) = 壓鏇願鹹憲鹽構範夢顧壓網齋顧鬱簾糧選鑰鑰 (糧壓築憲襯網鑰糧遞膚, 鏇艱淵壓顧遞繭構齋觸 ~ 鏇願獵鏇製鑰憲襯顧觸) 更多