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

April 1, 2025 updated by: Kristen Kelly, University of California, Irvine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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
      • Irvine, California, United States, 92697
        • Uci Beckman Laser Institute and Medical Clinic

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Patients will be excluded if any of the exclusion criteria applies

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LED treatment
LED treatment with Celluma POD device after laser test area
Device: Celluma POD
A blue and near infrared handheld LED device
No Intervention: Control
No treatment after laser test area

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days to Healing
Time Frame: Assessed from Day 0 to Day 55, up to 56 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
Time Frame: Assessed from Day 0 to Day 13, up to 14 days
A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome.
Assessed from Day 0 to Day 13, up to 14 days

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

BioPhotas

Investigators

  • Principal Investigator: Kristen Kelly, MD, University of California, Irvine

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 (Actual)

April 1, 2021

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

March 30, 2024

Study Registration Dates

First Submitted

April 4, 2021

First Submitted That Met QC Criteria

April 4, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 20216401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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