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

Derek Ho, Ekaterina Kraeva, Theodore Wun, Roslyn Rivkah Isseroff, Jared Jagdeo

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

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/cm2 up to 640 J/cm2 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/cm2). LED-RL dose will be escalated in subsequent groups (320 J/cm2, 480 J/cm2 and 640 J/cm2). 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/cm2 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. Trial registration: ClinicalTrials.gov NCT02630303. Registered on 9 December 2015.

Original languageEnglish (US)
Article number385
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Aug 2 2016

Fingerprint

Randomized Controlled Trials
Light
Skin
Phototherapy
Fibrosis
Safety
Maximum Tolerated Dose
Therapeutics
Cicatrix
Healthy Volunteers

Keywords

  • High-fluence
  • Keloid
  • LED-RL
  • Light-emitting diode-red light
  • Phototherapy
  • RCT
  • Scar
  • Skin fibrosis
  • Wound healing

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{4d9cbb17b6d34715a2e8d2a6bdd40674,
title = "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",
abstract = "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/cm2 up to 640 J/cm2 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/cm2). LED-RL dose will be escalated in subsequent groups (320 J/cm2, 480 J/cm2 and 640 J/cm2). 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/cm2 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. Trial registration: ClinicalTrials.gov NCT02630303. Registered on 9 December 2015.",
keywords = "High-fluence, Keloid, LED-RL, Light-emitting diode-red light, Phototherapy, RCT, Scar, Skin fibrosis, Wound healing",
author = "Derek Ho and Ekaterina Kraeva and Theodore Wun and Isseroff, {Roslyn Rivkah} and Jared Jagdeo",
year = "2016",
month = "8",
day = "2",
doi = "10.1186/s13063-016-1518-7",
language = "English (US)",
volume = "17",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",

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TY - JOUR

T1 - A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin

T2 - Study protocol for a randomized controlled trial

AU - Ho, Derek

AU - Kraeva, Ekaterina

AU - Wun, Theodore

AU - Isseroff, Roslyn Rivkah

AU - Jagdeo, Jared

PY - 2016/8/2

Y1 - 2016/8/2

N2 - 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/cm2 up to 640 J/cm2 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/cm2). LED-RL dose will be escalated in subsequent groups (320 J/cm2, 480 J/cm2 and 640 J/cm2). 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/cm2 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. Trial registration: ClinicalTrials.gov NCT02630303. Registered on 9 December 2015.

AB - 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/cm2 up to 640 J/cm2 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/cm2). LED-RL dose will be escalated in subsequent groups (320 J/cm2, 480 J/cm2 and 640 J/cm2). 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/cm2 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. Trial registration: ClinicalTrials.gov NCT02630303. Registered on 9 December 2015.

KW - High-fluence

KW - Keloid

KW - LED-RL

KW - Light-emitting diode-red light

KW - Phototherapy

KW - RCT

KW - Scar

KW - Skin fibrosis

KW - Wound healing

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U2 - 10.1186/s13063-016-1518-7

DO - 10.1186/s13063-016-1518-7

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JO - Trials

JF - Trials

SN - 1745-6215

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