Laser Treated Scars and Optical Coherence Tomography (OCT)

Study Overview
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Brief Summary
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The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.

Official Title
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Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography

Conditions
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Scar

Intervention / Treatment
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* Device: Er:YAG laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18 years or older Patients should have Fitzpatrick skin types of I-IV Patients should have mild to severe post-surgical scarring located on head and neck Scar lengths of at least 3 cm. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study Scar size less than 3 cm in length Pregnant or lactating females Fitzpatrick skin type of V-VI Scleroderma Photosensitivity Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Er:YAG laser Group<br>The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval. | Device: Er:YAG laser<br>* 2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities.<br>|
| No Intervention: Control (No Intervention) Group<br>The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POSAS Scar Assessment | Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin). | Up to 13 weeks | 
| Surgical Scar Blood Flow | As measured using optical coherence tomography | Up to 13 weeks | 
| Surgical Scar Skin Roughness | As measured using optical coherence tomography | Up to 13 weeks | 
| Surgical Scar Collagen Content | As measured using optical coherence tomography | Up to 13 weeks | 
| Surgical Scar Epidermal Thickness | As measured using optical coherence tomography | Up to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Adverse events reported by participant and evaluated by treating physician | Up to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical scar