Derek Ho

Ekaterina Kraeva

Jared Jagdeo

R. Rivkah Isseroff

Ted Wun

Trials

PubMed

Springer - Publisher Connector

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

SPIRIT trial registration data. (DOCX 110 kb

Derek Ho (2194216)

Ekaterina Kraeva (3568013)

Ted Wun (591795)

R. Isseroff (3568016)

Jared Jagdeo (816700)

The Francis Crick Institute

Additional file 3: of 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

Additional file 1: of 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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BackgroundSkin 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&nbsp;J/cm(2) up to 640&nbsp;J/cm(2) in healthy subjects.Methods/designThis 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&nbsp;J/cm(2)). LED-RL dose will be escalated in subsequent groups (320&nbsp;J/cm(2), 480&nbsp;J/cm(2) and 640&nbsp;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&nbsp;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.DiscussionThis 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 registrationClinicalTrials.gov NCT02630303 . Registered on 9 December 2015

Ho, Derek

Kraeva, Ekaterina

Wun, Ted

Isseroff, R Rivkah

Jagdeo, Jared

eScholarship - University of California

https://figshare.com/articles/Additional_file_3_of_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/4457051

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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The Francis Crick Institute

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eScholarship - University of California