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在最大使用条件下使用防晒对防晒活性成分的血度的影响:随机临床试验
Murali K Matta1, Robbert Zusterzeel1, Nageswara R Pilli1
1Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA
|May 7, 2019
概括
四种常见的防晒成分被系统吸收,超过了FDA的安全门. 需要进一步研究以了解这些发现对防晒安全性的临床意义.
科学领域:
- 皮肤病学和药理学
- 毒理学和药物安全
背景情况:
- 美国食品和药物管理局 (FDA) 要求对防晒的活性成分进行非临床毒理评估,其系统吸收超过0. 5 ng/ ml.
- 了解系统吸收对于评估防晒的安全性和合规性至关重要.
研究的目的:
- 为了确定四个活性成分 (avobenzone,oxybenzone,octocrylene,ecamsule) 在商用防晒中的系统吸收.
- 评估这些成分是否达到符合FDA非临床毒理测试要求的血度.
主要方法:
- 在24名健康志愿者中进行了一项随机临床试验.
- 参与者在最大使用条件下 (每平方公分2至75%的身体表面积,每天四次) 应用四种防晒剂之一 (两种喷雾剂,一种乳液,一种乳液).
- 在七天内采集血液样本以测量活性成分的血度.
主要成果:
- 所有四种防晒剂的活性成分 (avobenzone,oxybenzone,octocrylene,ecamsule) 都被系统吸收.
- 在第一天四次应用后,所有成分的血度都超过了FDA的0. 5 ng/ mL值.
- 皮疹是最常见的不良事件,每组防晒剂中发生1例.
结论:
- 在最大限度的使用条件下,防晒成分的系统吸收超过了FDA的值,表明需要进一步的安全评估.
- 虽然检测到吸收,但这些发现并不意味着个人应该避免使用防晒.
- 需要进一步研究以确定这些全身度的临床意义.
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