High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin

March 29, 2017 updated by: Jared Jagdeo, MD, MS

Phase I Study of High Fluence Light Emitting Diode-Red Light (LED-RL) in Human Skin

The goal of this study is to establish the safety of high fluence LED-RL from 160 J/cm2 up to 640 J/cm2 in healthy subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in human skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Skin fibrosis is involved in a variety of pathologic processes ranging from exuberant scar formation secondary to surgery or trauma, as in hypertrophic and keloid scars, to immune-mediated processes such as scleroderma and chronic graft-versus-host disease. As highlighted by quality-of-life studies, skin fibrosis imparts a significant socioeconomic burden due to the functional, aesthetic, and psychosocial impact it has on a patient's life. The effects of visible light, while common in the environment (visible spectrum accounts for 44% of total solar energy), remain undefined. An important safety feature of visible red light (600 nm to 700 nm) is that it does not generate pro-carcinogenic DNA damage as does ultraviolet (UV) light. Recently published clinical observations indicate that red light in combination with other modalities such as photosensitizers in combined red light photodynamic therapy can lessen skin fibrosis. However, preliminary in vitro data generated by the investigator's research group suggests that red light can function as a stand-alone treatment, eliminating the side-effects of chemical photosensitizers and the potential long-term harm of current UV therapy. Furthermore, commercially available light emitting diode-red light (LED-RL) units exist and are already FDA-cleared for other dermatological uses (such as rhytides and acne), thus clinical translation for use in skin fibrosis could occur relatively quickly following safety and efficacy demonstration. Developing high fluence LED-RL phototherapy as a treatment for skin fibrosis would represent an important advance in scarring conditions that lacks the serious systemic side effects associated with immunomodulatory agents (such as oral steroids); avoids the need for invasive, painful injections with anti-fibrotic agents (such as intralesional steroids, 5-fluorouracil and bleomycin); and eliminates the UV-induced DNA damage associated with skin cancer and photoaging that are associated with current UVA/UVA1 and UVB/narrowband UVB phototherapy. To the investigator research group's knowledge, no clinical trials have been performed to determine the safety of high fluence LED-RL for treatment of skin fibrosis. Therefore, the innovation of this approach is that the investigator research group intend to study high fluence LED-RL as a safe modality for treatment of skin fibrosis.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Mather, California, United States, 95655
        • Sacramento VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects of any sex, ethnicity and age
  • Nondominant proximal anterior forearm is wide enough to ensure reproducible placement of LED-RL phototherapy or mock therapy hand-held unit
  • Available and willing to attend all clinic visits
  • Able and willing to give informed consent

Exclusion Criteria:

  • Subjects using any photosensitizers (i.e. lithium, melatonin, phenothiazine antipsychotics, antibiotics)
  • Subjects with diabetes mellitus (DM)
  • Subjects with a history of skin cancer; basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
  • Subjects with systemic lupus erythematous (SLE)
  • Subjects with any other medical condition that could be compromised by exposure to the proposed treatment
  • Subjects with light-sensitive conditions or on photosensitizing medications (All subjects will be tested for photosensitivity per manufacturer user guide instructions)
  • Subjects with open wounds on the nondominant proximal anterior forearm
  • Subjects with fibrotic skin disease or other skin conditions on the nondominant proximal anterior forearm
  • Subjects with tattoos that cover the procedure site on the nondominant proximal anterior forearm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LED-RL Phototherapy

The protocol for dose escalation requires subjects be enrolled sequentially in groups of five (three subjects randomized to LED-RL phototherapy and two subjects randomized to mock therapy).

After either a maximally tolerated dose (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 to satisfy Hanley's Rule of Three, such that it can be concluded with 95% confidence that fewer than 1 person in 10 will experience an adverse event.
Device: LED-RL Phototherapy

The maximum recommended starting dose (MSRD) (160 J/cm2) will be administered to Group 1's LED-RL phototherapy randomized subjects and the LED-RL dose will be escalated in subsequent groups using the classical method for dose escalation as described by Spilker: starting with dose (X) increased by an equal amount (in this instance: X=160 J/cm2, 2X=320 J/cm2, 3X=480 J/cm2, 4X=640 J/cm2). Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered the upper limit of subject tolerance.

All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks.

Other Names:
  • Omnilux New-U (Photo Therapeutics, Carlsbad, CA)
Sham Comparator: Mock Therapy

The protocol for dose escalation requires subjects be enrolled sequentially in groups of five (three subjects randomized to LED-RL phototherapy and two subjects randomized to mock therapy).

After either a maximally tolerated dose (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 to satisfy Hanley's Rule of Three, such that it can be concluded with 95% confidence that fewer than 1 person in 10 will experience an adverse event.
Device: Mock Therapy

Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit and only generates warmth and does not emit LED-RL.

All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks.

Other Names:
  • Mock therapy unit (Photo Therapeutics, Carlsbad, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedure-related common expected procedure outcomes and adverse events (safety and tolerability)
Time Frame: 3 weeks
To evaluate safety of high fluence LED-RL Phototherapy by recording any common expected procedure outcomes [warmth, erythema (redness), and edema (swelling) that are mild, self-limited, and are expected to last less than 24 hours] and adverse events (including: second-degree or higher skin burning or blistering, erythema lasting more than 24 hours, severe swelling, pain, ulceration, change in sensation, and/or muscle weakness], via assessment during and immediately post-procedure, subject diary of adverse events and weekly phone calls)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jared Jagdeo, MD, MS

Collaborators

VA Northern California Health Care System
East Bay Institute for Research and Education

Investigators

  • Principal Investigator: Jared Jagdeo, MD, MS, Sacramento VA Medical Center- Dermatology Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 10, 2015

First Posted (Estimate)

December 15, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-12-00756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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