Phase 1 Study of HF-LED-RL in Fitzpatrick Skin Types I to III

NCT03433222 | Unknown Phase 1 DMC FDA Device

• 1 other identifier: 18-01-00804
• 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 at fluence of 480 J/cm2 and 640 J/cm2 in healthy non-Hispanic, Caucasian subjects. The hypothesis is that high fluence LED-RL phototherapy is safe in non-Hispanic, Caucasians.

Conditions

Skin Diseases; Keloid; Scar; Fibrosis; Hypertrophic Skin

Keywords

light emitting diode-red light; high fluence; red light; RCT

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  The primary objective is to determine the maximum tolerated dose.

  3 consecutive weeks

Secondary Outcomes (2)

• Assessment of safety profile by evaluating incidence of procedure-related common procedure outcomes

  3 consecutive weeks

• Assessment of safety profile by evaluating incidence of adverse events

  3 consecutive weeks

Study Arms (2)

HF-LED-RL Phototherapy

EXPERIMENTAL

The protocol for dose escalation requires subjects be enrolled sequentially in groups of five (three subjects randomized to HF-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 24 or 27 HF-LED-RL phototherapy subjects (for a total of 30) and 16 or 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: HF-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 HF-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 24 or 27 HF-LED-RL phototherapy subjects (for a total of 30) and 16 or 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

HF-LED-RL Phototherapy DEVICE

The starting dose of 480 J/cm2 will be administered to Group 1's HF-LED-RL phototherapy randomized subjects and the HF-LED-RL dose will be escalated in the subsequent group to 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 in 2 or more subjects 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)

HF-LED-RL Phototherapy

Mock Therapy DEVICE

Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit. The mock therapy unit 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

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

You may qualify if:

• Healthy subjects of any sex and age
• Non-Hispanic, Caucasian race/ethnicity
• 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.
• Subjects with systemic lupus erythematous (SLE)
• Subjects with light-sensitive conditions (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
• Subjects of an ethnic race group other than Non-Hispanic, Caucasian
• Subjects who have previously participated in the VA Northern California's "Phase 1 Study of LED-RL in Human Skin"

Sponsors & Collaborators

• VA Northern California Health Care System: lead
• East Bay Institute for Research and Education: collaborator

Study Sites (1)

Sacramento VA Medical Center

Mather, California, 95655, United States

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 18459515 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Wang EB, Kaur R, Nguyen J, Ho D, Austin E, Maverakis E, Li CS, Hwang ST, Isseroff RR, Jagdeo J. A single-blind, dose-escalation, phase I study of high-fluence light-emitting diode-red light on Caucasian non-Hispanic skin: study protocol for a randomized controlled trial. Trials. 2019 Mar 20;20(1):177. doi: 10.1186/s13063-019-3278-7.

  PMID: 30894210 DERIVED

MeSH Terms

Conditions

Skin Diseases; Keloid; Cicatrix; Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jared Jagdeo, MD, MS

  Physician, Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared Jagdeo, MD, MS

CONTACT

916-451-7245; Jared.Jagdeo@va.gov

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: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Dermatology

Model Details: Single-blind, dose escalation, randomized controlled Phase 1 study

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: January 31, 2018
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)