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

Not Applicable

Completed

• Conditions: Wound Heal
• Interventions: Device: Celluma POD

• Registration Number: NCT04834817
• Lead Sponsor: University of California, Irvine

Brief Summary

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

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-04
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-08
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Results First Submitted: 2025-02-06
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Results First Posted: 2025-04-13
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LED treatment	Celluma POD	LED treatment with Celluma POD device after laser test area

Primary Outcome Measures

Name	Time	Method
Days to Healing	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 Outcome Measures

Name	Time	Method
Pain Level	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.

Trial Locations

Locations (1)

UCI Beckman Laser Institute and Medical Clinic; 🇺🇸 Irvine, California, United States