Recruiting
Phase 1

HF-LED-RL

Sponsor:

VA Northern California Health Care System

Code:

NCT03433222

Conditions

Skin Diseases

Keloid

Scar

Fibrosis

Hypertrophic Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HF-LED-RL Phototherapy

Mock Therapy

Study Details

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

Study ID

NCT03433222

Start date

Jan 31, 2018

Status verified date

Feb, 2018

Completion date

Jan 8, 2019

Anticipated

Primary completion date

Jan 8, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

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.
  • 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"

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HF-LED-RL Phototherapy

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.

sham comparator: Mock Therapy

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.

Interventions

HF-LED-RL Phototherapy

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.

Mock Therapy

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.

Primary outcome measure

  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 consecutive weeks ]

Central Contacts and Locations

Central contacts

Jared Jagdeo, MD, MS

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

Locations

Sacramento VA Medical Center

Recruiting

Mather, California, United States, 95655

Contacts

Jared Jagdeo, MD, MS

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

Erica Wang, MD

Erica.Wang2@va.gov

Principal Investigator:

Jared Jagdeo, MD, MS

More Information

Sponsor

VA Northern California Health Care System

Last update posted

Feb 14, 2018

Last verified

Feb, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Northern California Health Care System on 2018-02-14.