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

Study Overview
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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.

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

Conditions
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Wound Heal

Intervention / Treatment
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* Device: Celluma POD


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |