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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04834817
• Other study ID #: 20216401
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Intervention

Device:
• Celluma POD
A blue and near infrared handheld LED device

Locations

Country	Name	City	State
United States	UCI Beckman Laser Institute and Medical Clinic	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	BioPhotas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	56 days
Secondary	Pain level	A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome.	56 days