Safety of light emitting diode-red light on human skin: Two randomized controlled trials.,Journal of Biophotonics

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Safety of light emitting diode-red light on human skin: Two randomized controlled trials.
Journal of Biophotonics ( IF 2.0 ) Pub Date : 2019-12-08 , DOI: 10.1002/jbio.201960014
Jared Jagdeo _{1,

2} , Julie K Nguyen _{3,

4} , Derek Ho _{1,

2} , Erica B Wang _{1,

2} , Evan Austin ₁ , Andrew Mamalis _{1,

3} , Ramanjot Kaur _{1,

2} , Ekaterina Kraeva _{1,

2} , Joshua M Schulman _{1,

2} , Chin-Shang Li ₅ , Samuel T Hwang ₁ , Ted Wun _{6,

7,

8} , Emanual Maverakis ₁ , R Rivkah Isseroff _{1,

2}

Affiliation

Therapeutic applications of light emitting diode‐red light (LED‐RL) are expanding, yet data on its clinical effects are lacking. Our goal was 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 3 weeks at fluences of 160‐640 J/cm² for all skin types (STARS 1, n = 60) and at 480‐640 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. We determined that 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.

中文翻译：

发光二极管红光对人体皮肤的安全性：两项随机对照试验。

发光二极管红光（LED-RL）的治疗应用正在扩大，但缺乏其临床效果的数据。我们的目标是评估高通量 LED-RL (≥160 J/cm ² ) 的安全性。在两项 I 期、单盲、剂量递增、随机对照试验中，健康受试者前臂接受 LED-RL 或模拟照射，每周三次，持续 3 周，所有皮肤类型的能量密度为 160-640 J/cm ² (STARS 1 ，n = 60)，非西班牙裔白种人则为 480‐640 J/cm ² (STARS 2，n = 55)。主要结局是不良事件（AE）的发生率。最大耐受剂量是不会引起预定 AE 的最高注量。剂量限制性 AE，包括起泡和长时间红斑，在 STARS 1 (n = 1) 中以 480 J/cm ²发生，在 STARS 2 (n = 2) 中以 640 J/cm ²发生。暂时性红斑和色素沉着过度的不良事件较轻微。没有发生严重的 AE。我们确定，对于有色皮肤，LED-RL 在高达 320 J/cm ²的强度下是安全的，对于非西班牙裔白种人来说，在 480 J/cm ^{2 的}强度下是安全的。 LED-RL 可能会根据种族和民族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 治疗各种疾病的功效。

更新日期：2019-12-08

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