A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial
A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-016-1518-7
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发表时间：
2016-08-02
期刊：
影响因子：
2.5
通讯作者：
Jagdeo, Jared
中科院分区：
文献类型：
--
作者：
Ho, Derek;Kraeva, Ekaterina;Jagdeo, Jared
背景：皮肤纤维化涉及多种病理状况，从继发于手术或创伤的疤痕形成到免疫介导的过程。皮肤纤维化是一个重大的国际健康问题，据估计，全世界每年有超过1亿人受到影响，但几乎没有有效的治疗选择。我们的研究小组产生的初步体外数据表明，红光可以作为皮肤纤维化的独立治疗方法。据我们所知，之前没有进行临床试验来确定高影响度（剂量）发光二极管红光（LED-RL）光疗的安全性。本研究的目的是评估健康受试者中160 J/cm(2)至640 J/cm(2)的LED-RL影响的安全性。方法/设计：这是一项单盲、剂量递增、随机对照的I期研究，旨在评估高通量LED-RL对人体皮肤的安全性。剂量递增方案要求受试者按顺序入组，每组5人。在每组中，三名受试者将随机接受LED-RL光疗，两名受试者随机接受模拟治疗。第一组随机接受LED-RL光疗的受试者将接受最大推荐起始剂量（160 J/cm(2)）。LED-RL剂量将在随后的组中逐步增加(320 J/cm(2), 480 J/cm（2)和640 J/cm(2)）。最大耐受剂量（MTD）定义为低于产生不可接受但可逆毒性的剂量的剂量水平，被认为是受试者耐受的上限。在建立MTD或达到640 J/cm(2)的研究终点后，将额外招募27名LED-RL光疗受试者（共30人）和18名模拟治疗受试者（共20人）（随机确定）。每位受试者将接受共9个程序，每周3次，连续3周。讨论：本研究可能为高通量LED-RL光疗对人体皮肤的影响提供重要的安全性信息，并有助于促进未来的II期研究，以评估高通量LED-RL作为一种潜在的无创、安全、便携、家庭治疗皮肤纤维化的疗效。
Background: Skin fibrosis is involved in a variety of pathologic conditions ranging from scar formation secondary to surgery or trauma to immune-mediated processes. Skin fibrosis is a significant international health problem with an estimated incidence of greater than 100 million people affected per year worldwide with few effective treatment options available. Preliminary in vitro data generated by our research group suggests that red light can function as a stand-alone treatment for skin fibrosis. To our knowledge, no prior clinical trials have been performed to determine the safety of high-fluence (dose) light-emitting diode-red light (LED-RL) phototherapy. The goal of this study is to evaluate the safety of LED-RL fluences from 160 J/cm(2) up to 640 J/cm(2) in healthy subjects.Methods/design: This is a single-blind, dose escalation, randomized controlled, phase I study to evaluate the safety of high-fluence LED-RL on human skin. The protocol for dose escalation requires subjects be enrolled sequentially in groups of five. Within each group, three subjects will be randomized to LED-RL phototherapy and two subjects randomized to mock therapy. Subjects in group 1 randomized to LED-RL phototherapy will receive the maximum recommended starting dose (160 J/cm(2)). LED-RL dose will be escalated in subsequent groups (320 J/cm(2), 480 J/cm(2) and 640 J/cm(2)). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered to be the upper limit of subject tolerance. After either a MTD has been established, or the study endpoint of 640 J/cm(2) has been achieved, an additional 27 LED-RL phototherapy subjects (for a total of 30) and 18 mock therapy subjects (for a total of 20) (determined randomly) will be enrolled. Each subject will receive a total of nine procedures, three times per week for three consecutive weeks.Discussion: This study may provide important safety information on the effects of high-fluence LED-RL phototherapy on human skin and help facilitate future phase II studies to evaluate the efficacy of high-fluence LED-RL as a potential noninvasive, safe, portable, at-home therapy for treatment of skin fibrosis.