Safety of light emitting diode-red light on human skin: Two randomized controlled trials.
Safety of light emitting diode-red light on human skin: Two randomized controlled trials.
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DOI：
10.1002/jbio.201960014
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发表时间：
2020-03
影响因子：
2.8
通讯作者：
Isseroff RR
中科院分区：
文献类型：
--
作者：
Jagdeo J;Nguyen JK;Ho D;Wang EB;Austin E;Mamalis A;Kaur R;Kraeva E;Schulman JM;Li CS;Hwang ST;Wun T;Maverakis E;Isseroff RR
发光二极管红光(LED-RL)的治疗应用正在扩大，但其临床效果的数据缺乏。评价高通量发光二极管RL(≥160J/cm~2)的安全性。在两个I期单盲剂量递增随机对照试验中，健康受试者接受LED-RL或模拟前臂照射，每周三次，所有皮肤类型(星形1，n=60)的照射剂量为160至640 J/cm2，非西班牙裔高加索人(星形2，n=55)的照射强度为480至640 J/cm2。主要结果是不良事件(AEs)的发生率。最大耐受剂量是不会引起预定义不良反应的最高剂量。星1(n=1)和星2(n=2)分别出现480J/cm2和640J/cm2的剂量限制不良反应，包括水泡和长时间红斑。一过性红斑和色素沉着的AES较轻。无严重不良反应发生。LED-RL对有色人种的安全性高达320 J/cm2，对非西班牙裔高加索人的安全性高达480 J/cm2。LED-RL可能会根据种族和民族的不同而产生不同的皮肤效应，深色皮肤对光更敏感。这些发现可能会指导未来的研究，以评估LED-RL对各种疾病的疗效。ClinicalTrials.gov、NCT02630303和NCT03433222发光二极管(LED)技术具有广泛的医疗应用。这是首次对注量大于160 J/cm2的LED红光(LED-RL)对人体皮肤的安全性进行的临床研究。在两个阶段的I期单盲、剂量递增、随机对照试验中，我们发现LED-RL对有色人种皮肤的安全性高达320 J/cm2，对非西班牙裔高加索人的安全性高达480 J/cm2。高通量LED-RL可能会因种族和民族而产生不同的皮肤效应。
Therapeutic applications of light emitting diode-red light (LED-RL) are expanding, yet data on its clinical effects are lacking. To evaluate the safety of high fluence LED-RL (≥160 J/cm2). In two phase I, single-blind, dose escalation, randomized controlled trials, healthy subjects received LED-RL or mock irradiation to the forearm thrice weekly for three weeks at fluences of 160 to 640 J/cm2 for all skin types (STARS 1, n=60) and at 480 to 640 J/cm2 for non-Hispanic Caucasians (STARS 2, n=55). The primary outcome was the incidence of adverse events (AEs). The maximum tolerated dose was the highest fluence that did not elicit predefined AEs. Dose-limiting AEs, including blistering and prolonged erythema, occurred at 480 J/cm2 in STARS 1 (n=1) and 640 J/cm2 in STARS 2 (n=2). AEs of transient erythema and hyperpigmentation were mild. No serious AEs occurred. LED-RL is safe up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasian individuals. LED-RL may exert differential cutaneous effects depending on race and ethnicity, with darker skin being more photosensitive. These findings may guide future studies to evaluate the efficacy of LED-RL for the treatment of various diseases. ClinicalTrials.gov, NCT02630303 and NCT03433222 Light emitting diode (LED) technology has therapeutic applications for a wide range of medical conditions. These are the first clinical investigations into the safety of LED-red light (LED-RL) on human skin at fluences above 160 J/cm2. In two phase I, single-blind, dose escalation, randomized controlled trials, we found that LED-RL is safe up to 320 J/cm2 for skin of color and 480 J/cm2 for non-Hispanic Caucasian individuals. High fluence LED-RL may exert differential cutaneous effects depending on race and ethnicity.
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影响因子：
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作者：
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