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

NCT02630303 | Completed Phase 1 DMC

• 1 other identifier: 15-12-00756
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibrosis; Scarring; Scar; Wounds; Injuries; Keloid; Cicatrix; Hypertrophic

Keywords

light emitting diode-red light; LED-RL; high fluence; skin fibrosis; wound healing; scar; keloid; RCT

Outcome Measures

Primary Outcomes (1)

• Incidence of procedure-related common expected procedure outcomes and adverse events (safety and tolerability)

  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

Study Arms (2)

LED-RL Phototherapy

EXPERIMENTAL

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

Mock Therapy

SHAM COMPARATOR

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

Interventions

LED-RL Phototherapy DEVICE

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.

Also known as: Omnilux New-U (Photo Therapeutics, Carlsbad, CA)

LED-RL Phototherapy

Mock Therapy DEVICE

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.

Also known as: Mock therapy unit (Photo Therapeutics, Carlsbad, CA)

Mock Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jared Jagdeo, MD, MS: lead
• VA Northern California Health Care System: collaborator
• East Bay Institute for Research and Education: collaborator

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

Location

Related Publications (6)

• Jagdeo JR, Adams LE, Brody NI, Siegel DM. Transcranial red and near infrared light transmission in a cadaveric model. PLoS One. 2012;7(10):e47460. doi: 10.1371/journal.pone.0047460. Epub 2012 Oct 15.

  PMID: 23077622 RESULT

• Mamalis A, Jagdeo J. Light-emitting diode-generated red light inhibits keloid fibroblast proliferation. Dermatol Surg. 2015 Jan;41(1):35-9. doi: 10.1097/01.DSS.0000452650.06765.51.

  PMID: 25485805 RESULT

• Sadick NS. A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008 Dec;7(4):263-7. doi: 10.1111/j.1473-2165.2008.00404.x.

  PMID: 19146602 RESULT

• Sadick NS. Handheld LED array device in the treatment of acne vulgaris. J Drugs Dermatol. 2008 Apr;7(4):347-50.

  PMID: 18459515 RESULT

• Lev-Tov H, Mamalis A, Brody N, Siegel D, Jagdeo J. Inhibition of fibroblast proliferation in vitro using red light-emitting diodes. Dermatol Surg. 2013 Aug;39(8):1167-70. doi: 10.1111/dsu.12212. Epub 2013 Apr 16.

  PMID: 23590233 RESULT

• Ho D, Kraeva E, Wun T, Isseroff RR, Jagdeo J. 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. Trials. 2016 Aug 2;17:385. doi: 10.1186/s13063-016-1518-7.

  PMID: 27484782 DERIVED

MeSH Terms

Conditions

Fibrosis; Cicatrix; Wounds and Injuries; Keloid; Hypertrophy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical

Study Officials

• Jared Jagdeo, MD, MS

  Sacramento VA Medical Center- Dermatology Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Physician

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 15, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

US (1)