{"title":"斯来吉兰透皮系统(STS):人体皮肤安全性评估","authors":"M. Pauporte, A. Azzaro, G. Moonsammy, H. Maibach","doi":"10.1081/CUS-200035366","DOIUrl":null,"url":null,"abstract":"The selegiline transdermal system (STS) is being developed to treat major depressive disorder. In a Phase I clinical study, the STS (20 mg/20 cm2) produced mild dermal irritability and demonstrated a low potential for contact allergenicity. In Phase III multicenter studies in major depression, over 1800 patients have been evaluated for dermal safety to reveal an overall rate of application site reactions (ASRs) with STS of 21.8% compared with a placebo rate of 9.7%. Discontinuation rates due to dermal adverse events in clinical studies were low (3.5%). Overall, the STS demonstrated good tolerability regarding ASRs and the potential for delayed contact hypersensitivity.","PeriodicalId":17547,"journal":{"name":"Journal of Toxicology-cutaneous and Ocular Toxicology","volume":"14 1","pages":"179 - 187"},"PeriodicalIF":0.0000,"publicationDate":"2005-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"6","resultStr":"{\"title\":\"Selegiline Transdermal System (STS): Assessments of Dermal Safety in Human\",\"authors\":\"M. Pauporte, A. Azzaro, G. Moonsammy, H. Maibach\",\"doi\":\"10.1081/CUS-200035366\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The selegiline transdermal system (STS) is being developed to treat major depressive disorder. In a Phase I clinical study, the STS (20 mg/20 cm2) produced mild dermal irritability and demonstrated a low potential for contact allergenicity. In Phase III multicenter studies in major depression, over 1800 patients have been evaluated for dermal safety to reveal an overall rate of application site reactions (ASRs) with STS of 21.8% compared with a placebo rate of 9.7%. Discontinuation rates due to dermal adverse events in clinical studies were low (3.5%). Overall, the STS demonstrated good tolerability regarding ASRs and the potential for delayed contact hypersensitivity.\",\"PeriodicalId\":17547,\"journal\":{\"name\":\"Journal of Toxicology-cutaneous and Ocular Toxicology\",\"volume\":\"14 1\",\"pages\":\"179 - 187\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2005-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Toxicology-cutaneous and Ocular Toxicology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1081/CUS-200035366\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Toxicology-cutaneous and Ocular Toxicology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1081/CUS-200035366","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Selegiline Transdermal System (STS): Assessments of Dermal Safety in Human
The selegiline transdermal system (STS) is being developed to treat major depressive disorder. In a Phase I clinical study, the STS (20 mg/20 cm2) produced mild dermal irritability and demonstrated a low potential for contact allergenicity. In Phase III multicenter studies in major depression, over 1800 patients have been evaluated for dermal safety to reveal an overall rate of application site reactions (ASRs) with STS of 21.8% compared with a placebo rate of 9.7%. Discontinuation rates due to dermal adverse events in clinical studies were low (3.5%). Overall, the STS demonstrated good tolerability regarding ASRs and the potential for delayed contact hypersensitivity.
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