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

NCT ID: NCT04834817

Last Updated: 2025-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a split-person study design where each participant has one arm with the intervention and the other arm that is control.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LED treatment

LED treatment with Celluma POD device after laser test area

Group Type EXPERIMENTAL

Celluma POD

Intervention Type DEVICE

A blue and near infrared handheld LED device

Control

No treatment after laser test area

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Celluma POD

A blue and near infrared handheld LED device

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioPhotas

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Kristen Kelly

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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UCI Beckman Laser Institute and Medical Clinic

Irvine, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20216401

Identifier Type: -

Identifier Source: org_study_id

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