背景:户外游泳运动员经常暴露于不良的环境条件,例如长期的阳光照射。由于防晒霜的丧失和皮肤对紫外线的敏感性增加,该人群仍然可能发生晒伤的风险,特别是紫外线B,在潮湿的条件下。先前的一些试验表明,有机防晒剂在运动后比无机防晒剂具有更长的保质期,因为它们具有与皮肤层更好结合的特性。同时,无机防晒霜往往会在皮肤表面形成一层,这样它们就可以更容易地去除。据我们所知,没有研究评估防晒霜的抗性,无机或有机,在印度尼西亚锻炼后。
目的:本研究旨在评估游泳者使用的无机和有机防晒剂的持久性。主要目的是评估在游泳1.5小时后防晒剂的持久性领域中,无机防晒剂是否与有机防晒剂一样好。
方法:这项研究是一项随机的,分裂的身体,双盲,非自卑,和Cikini的多中心临床试验,雅加达,印度尼西亚。每组估计有22名运动员,18-40岁,早上或下午练习,将使用计算机生成的随机化方法进行随机化。我们使用防晒因子(SPF)水平平均下降的差异计算了样本量,该差异根据研究人员设定的临床判断被认为是显着的,这是5。研究对象和研究人员都不知道将要使用的防晒霜的类型。该假设将使用配对样本t检验或Wilcoxon进行测试,以使用SPSS(20.0版;IBMCorp)评估有机和无机防晒剂之间每组SPF水平的差异。
结果:本研究已获得印度尼西亚大学医学伦理委员会学院的批准,并由印度尼西亚大学国际出版资助。注册过程已于2020年12月完成。
结论:本研究将测试准备进行主要研究的所有程序,从参与医生和合格游泳者的角度来看,包括几个潜在的障碍和挑战。研究结果将通过具有开放获取格式的同行评审期刊的出版物进行传播。这项研究将提供有关SPF30防晒霜持久性和游泳时使用的最佳防晒霜的信息,尤其是运动员。
背景:ClinicalTrials.govNCT04618536;https://clinicaltrials.gov/ct2/show/NCT04618536?term=NCT04618536。
UNASSIGNED:RR1-10.2196/42504。
BACKGROUND: Outdoor swimming athletes are often exposed to undesirable environmental conditions such as long-term sun exposure. The risk of sunburn can still occur in this population due to the loss of sunscreen and an increase in the sensitivity of the skin to ultraviolet rays, particularly ultraviolet B, in wet conditions. Some previous trials showed that organic sunscreens had a longer shelf-life than inorganic sunscreens after exercise due to their characteristics to bind better with the skin layer. Meanwhile, inorganic sunscreens tend to form layers on the skin\'s surface so that they can be more easily removed. To our knowledge, no studies evaluate sunscreens\' resistance, either inorganic or organic, after exercising in Indonesia.
OBJECTIVE: This
study aims to evaluate the persistence of inorganic versus organic sunscreens used by swimmers. The primary objective is to assess whether the inorganic sunscreen is as good as the organic sunscreen in the field of the persistence of sunscreens after swimming for 1.5 hours.
METHODS: This
study is a randomized, split-body, double-blind, noninferiority, and multicenter clinical
trial in Cikini, Jakarta, Indonesia. An estimated 22 athletes in each group, who aged 18-40 years and practice in the morning or afternoon, will be randomized using a computer-generated randomization method. We calculated the sample size using the difference in the average decrease in sun protection factor (SPF) levels that is considered significant based on the clinical judgment set by the researchers, which was 5. Neither the research subjects nor the researchers are aware of the type of sunscreen that will be applied. The hypothesis will be tested using paired-sample t test or Wilcoxon to assess the difference of SPF levels in each group between organic and inorganic sunscreens with SPSS (version 20.0; IBM Corp).
RESULTS: This study has been approved by the Ethical Committee Faculty of Medicine Universitas Indonesia and is funded by the International Publication Grant from Universitas Indonesia. The enrollment process was completed in December 2020.
CONCLUSIONS: This
study will test all procedures in preparation for conducting the main
study, including several potential obstacles and challenges from the perspective of participating physicians and eligible swimmers. The
study results will be disseminated through publications in a peer-reviewed journal with Open Access format. This study will provide information about SPF 30 persistence in sunscreens and the best type of sunscreen to be used while swimming, particularly for athletes.
BACKGROUND: ClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536?term=NCT04618536.
UNASSIGNED: RR1-10.2196/42504.