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Completed

NCT Number: NCT04834817

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Beckman Laser Institute and Medical Clinic

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celluma POD

Device

A blue and near infrared handheld LED device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • BioPhotas

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2021
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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