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

作用方式

抑制剂、激动剂

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)

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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 LLCViatris Pty Ltd.Bausch 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/序列

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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15

项与克林霉素磷酸酯/维A酸相关的文献（医药）

2014-05-01·JAMA Dermatology1区 · 医学

Characterizing the Relationship Between Free Drug Samples and Prescription Patterns for Acne Vulgaris and Rosacea

1区 · 医学

Article

作者: Lane, Alfred T. ; Stafford, Randall S. ; Hurley, Michael P.

IMPORTANCEDescribing the relationship between the availability of free prescription drug samples and dermatologists' prescribing patterns on a national scale can help inform policy guidelines on the use of free samples in a physician's office.OBJECTIVESTo investigate the relationships between free drug samples and dermatologists' local and national prescribing patterns and between the availability of free drug samples and prescription costs.DESIGN, SETTING, AND PARTICIPANTSCross-sectional study investigating prescribing practices for acne, a common dermatologic condition for which free samples are often available. The settings were, first, the offices of nationally representative dermatologists from the National Disease and Therapeutic Index (an IMS Health Incorporated database) and, second, an academic medical center clinic without samples. Participants were ambulatory patients who received a prescription from a dermatologist for a primary initial diagnosis of acne vulgaris or rosacea in 2010.MAIN OUTCOMES AND MEASURESNational trends in dermatologist prescribing patterns, the degree of correlation between the availability of free samples and the prescribing of brand-name medications, and the mean cost of acne medications prescribed per office visit nationally and at an academic medical center without samples.RESULTSOn a national level, the provision of samples with a prescription by dermatologists has been increasing over time, and this increase is correlated (r = 0.92) with the use of the branded generic drugs promoted by these samples. Branded and branded generic drugs comprised most of the prescriptions written nationally (79%), while they represented only 17% at an academic medical center clinic without samples. Because of the increased use of branded and branded generic drugs, the national mean total retail cost of prescriptions at an office visit for acne was conservatively estimated to be 2 times higher (approximately $465 nationally vs $200 at an academic medical center without samples).CONCLUSIONS AND RELEVANCEFree drug samples can alter the prescribing habits of physicians away from the use of less expensive generic medications. The benefits of free samples in dermatology must be weighed against potential negative effects on prescribing behavior and prescription costs.

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.

2012-06-01·Int. Journal of Clinical Pharmacology and Therapeutics4区 · 医学

Low intrinsic drug activity and dominant vehicle (placebo) effect in the topical treatment of acne vulgaris

4区 · 医学

Article

作者: Chiou, Win L

In drug treatment for acne, topical products alone or in combination with systemic products are commonly prescribed. It was recently pointed out by Chiou that oral tetracyclines, the most commonly prescribed systemic drugs, may not be as effective as commonly assumed because the effect of placebo can approach drug effects during the 4 - 12 weeks of daily administration. The present work evaluated the percent contribution of vehicle (placebo) toward the reported efficacy of reduction in total (inflammatory and non-inflammatory) lesion counts of 8 commonly prescribed topical preparations at the end of 10 - 12 weeks of daily administration. These preparations included 0.1% tretinoin, 0.1% adapalene, 5% dapsone, 1% clindamycin, a combination of benzoyl peroxide with adapalene or clindamycin, and a clindamycin-tretinoin combination. The mean reduction from drugs and vehicles were 42 ± 7.1%, and 23 ± 5.0%, respectively; the mean contribution of vehicle toward drug effect was 55 ± 15% (range 35 - 82%). For 5 benzoyl peroxide preparations evaluated (2 for 2.5%, and 3 for 5.0%), their respective means were 40 ± 9%, and 25 ± 15%, and vehicle-toward-drug contribution was 58 ± 31% (range 9 - 89%). The present work shows the great importance of vehicle effects in topical therapy; in some cases this effect approached 90%. The potential significance of the above findings in the development of more effective topical anti-acne drugs was discussed.

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
-	-	D10AF51	-

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

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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


NCT01047189 (CTgov)	临床4期	寻常痤疮	26	clindamycin phosphate+Ziana gel+tretinoin (Ziana Gel)	鑰製選醖廠衊鹽餘範觸(顧壓構積餘構衊廠壓壓) = 淵繭鑰窪壓製夢獵餘範獵糧築壓鹹夢鏇醖積鑰 (鬱選選鹹齋襯糧憲獵衊, 醖鹹鏇範遞醖獵淵積願 ~ 願齋繭網遞襯觸鏇淵淵) 更多	-	2011-10-17
				Tretinoin+Clindamycin (Clindamycin Plus Tretinoin Applied Separately)	鑰製選醖廠衊鹽餘範觸(顧壓構積餘構衊廠壓壓) = 網蓋顧構窪憲觸糧鏇蓋獵糧築壓鹹夢鏇醖積鑰 (鬱選選鹹齋襯糧憲獵衊, 淵構醖淵築構鹹夢窪鏇 ~ 選鑰餘膚憲壓選憲獵積) 更多
NCT00891982 (CTgov)	临床3期	寻常痤疮	60	CLINDAMYCIN PHOSPHATE/TRETINOIN+Benzoyl Peroxide (CTGel Plus BPO Wash)	範鏇遞構築遞獵鬱簾膚(範糧製窪窪夢鬱糧構衊) = 壓窪構繭壓膚壓觸廠鬱艱醖憲鹹積選鏇積夢鬱 (膚選糧遞憲鹽憲選衊襯, 襯窪簾蓋積築襯遞窪夢 ~ 構窪膚餘範夢醖鹽廠廠) 更多	-	2011-07-25
				CTGel (CTGel)	範鏇遞構築遞獵鬱簾膚(範糧製窪窪夢鬱糧構衊) = 襯醖鹽蓋鏇獵窪膚獵繭艱醖憲鹹積選鏇積夢鬱 (膚選糧遞憲鹽憲選衊襯, 膚糧鹽鏇選鹹鏇構製製 ~ 淵膚衊簾壓簾觸願廠壓) 更多