Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients A Randomized Clinical Trial
Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients A Randomized Clinical Trial
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DOI：
10.1001/jama.2019.20747
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发表时间：
2020-01-21
影响因子：
120.7
通讯作者：
Strauss, David G.
中科院分区：
文献类型：
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作者：
Matta, Murali K.;Florian, Jeffry;Strauss, David G.
重要性先前的一项初步研究表明，4种防晒霜活性成分可以被全身吸收；需要进一步的研究来确定额外活性成分的全身吸收，以及根据美国食品和药物管理局（FDA）的建议，全身暴露超过0.5 ng/mL的速度有多快。目的评价4种防晒产品中6种有效成分（阿伏苯宗、氧苯宗、八烯丙烯、同盐酸盐、octisalate和octinoxate）在单次使用和最大使用条件下的全身吸收和药代动力学。设计、环境和参与者在临床药理学单位（West Bend, Wisconsin）进行了48名健康参与者的随机临床试验。该研究于2019年1月至2月进行。干预措施参与者被随机分配到4种防晒产品中的一种，分别是乳液（n=12）、气溶胶喷雾（n=12）、非气溶胶喷雾（n=12）和泵喷雾（n=12）。在第1天0小时以2mg /cm(2)涂抹防晒霜至75%的体表面积，在第2天至第4天每隔2小时涂抹4次，并在21天内从每位参与者收集34份血液样本。主要结局和测量主要结局是第1 - 21天阿伏苯宗的最大血药浓度。次要结局是第1至21天氧苯酮、奥克烯、同型盐、奥克酸盐和奥克酸盐的最大血浆浓度。结果在48名随机受试者中（平均[SD]年龄38.7[13.2]岁，24名女性[50%]，23名白人[48%]，23名非洲裔美国人[48%]，1名亚洲人[2%]，1名未知种族/民族[2%]），44名（92%）完成了试验。所有6种活性成分的几何平均最大血浆浓度均大于0.5 ng/mL，并且在所有活性成分单次应用后第1天超过该阈值。每种产品配方中每种活性成分的总体最大血浆浓度显示在表中。最常见的不良反应是皮疹，有14名参与者出现皮疹。结论和相关性在临床药理学单位进行的这项研究中，对健康参与者的防晒霜应用进行了检查，在4种不同的防晒霜配方中，所有6种被测试的活性成分都被全身吸收，其血浆浓度超过了FDA的阈值，可能会免除一些防晒霜的额外安全性研究。这些发现并不表明个人应该避免使用防晒霜。
IMPORTANCE A prior pilot study demonstrated the systemic absorption of 4 sunscreen active ingredients; additional studies are needed to determine the systemic absorption of additional active ingredients and how quickly systemic exposure exceeds 0.5 ng/mL as recommended by the US Food and Drug Administration (FDA).OBJECTIVE To assess the systemic absorption and pharmacokinetics of the 6 active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate) in 4 sunscreen products under single- and maximal-use conditions.DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at a clinical pharmacology unit (West Bend, Wisconsin) was conducted in 48 healthy participants. The study was conducted between January and February 2019.INTERVENTIONS Participants were randomized to 1 of 4 sunscreen products, formulated as lotion (n=12), aerosol spray (n=12), nonaerosol spray (n=12), and pump spray (n=12). Sunscreen product was applied at 2 mg/cm(2) to 75% of body surface area at 0 hours on day 1 and 4 times on day 2 through day 4 at 2-hour intervals, and 34 blood samples were collected over 21 days from each participant.MAIN OUTCOMES AND MEASURES The primary outcome was the maximum plasma concentration of avobenzone over days 1 through 21. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, homosalate, octisalate, and octinoxate over days 1 through 21.RESULTS Among 48 randomized participants (mean [SD] age, 38.7 [13.2] years; 24 women [50%]; 23 white [48%], 23 African American [48%], 1 Asian [2%], and 1 of unknown race/ethnicity [2%]), 44 (92%) completed the trial. Geometric mean maximum plasma concentrations of all 6 active ingredients were greater than 0.5 ng/mL, and this threshold was surpassed on day 1 after a single application for all active ingredients. The overall maximum plasma concentrations for each active ingredient for each product formulation are shown in the table. The most common adverse event was rash, which developed in 14 participants.[GRAPHICS]CONCLUSIONS AND RELEVANCE In this study conducted in a clinical pharmacology unit and examining sunscreen application among healthy participants, all 6 of the tested active ingredients administered in 4 different sunscreen formulations were systemically absorbed and had plasma concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. These findings do not indicate that individuals should refrain from the use of sunscreen.