Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment

NCT04834817 | Completed Results FDA Device

• 1 other identifier: 20216401
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Days to Healing

  The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.

  Assessed from Day 0 to Day 55, up to 56 days

Secondary Outcomes (1)

• Pain Level

  Assessed from Day 0 to Day 13, up to 14 days

Study Arms (2)

LED treatment

EXPERIMENTAL

LED treatment with Celluma POD device after laser test area

Device: Celluma POD

Control

NO INTERVENTION

No treatment after laser test area

Interventions

Celluma POD DEVICE

A blue and near infrared handheld LED device

LED treatment

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla.
• Subjects shall have given written informed consent for both the LED therapy and for clinical photography.

You may not qualify if:

• Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
• Subjects have previous photosensitivity problems (solar urticaria, etc.).
• Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
• Subjects taking any systemic drug with known immunosuppressant properties.
• Subjects applying any medications to the research site (inner biceps, close to the axilla).
• Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance.
• Subjects are smokers or have smoked within the last 30 days prior to the trial.
• Subjects have epilepsy or a history of seizures
• Subjects currently taking cortisone injections or any other kind of steroid injections(s)
• Subjects with known cancer tumor in the treatment area or metastasis

Sponsors & Collaborators

• University of California, Irvine: lead
• BioPhotas: collaborator

Study Sites (1)

UCI Beckman Laser Institute and Medical Clinic

Irvine, California, 92697, United States

Location

Results Point of Contact

• Title: Dr. Kristen Kelly, Professor and Chair, Dept. of Dermatology
• Organization: University of California, Irvine

kmkelly@hs.uci.edu

949-824-5515

Study Officials

• Kristen Kelly, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a split-person study design where each participant has one arm with the intervention and the other arm that is control.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: April 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 13, 2025
• Results First Posted: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)