Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT

Study Overview
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Brief Summary
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This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen content, and epidermal thickness.

Official Title
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Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Device: Alma - Harmony XL Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients should be 18-90 years of age Patients should have Fitzpatrick skin types of I-III Patients should have at least mild acne Exclusion Criteria: The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study Pregnant or lactating females Fitzpatrick skin type of IV-VI A history of keloids or hypertrophic scars Scleroderma Photosensitivity Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months Subjects with a known history of herpes simplex

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser Treatment<br>Patients will receive one laser treatment (week 0) with the Erbium YAG laser at a 2940nm wavelength (Alma - Harmony XL Laser) and parameters corresponding with their acne scar severity. They will then return to the clinic 1, 4 and 8 weeks (7, 30, and 56 days + 7 days) after the treatment for their scars to be evaluated under optical coherence tomography. Laser parameters are as follows: iPixelEr 2940nm Erbium:YAG Module: mild scars: 7 by 7 (7X7) mm tip, energy 1400-1600 millijoules/P (mJ), pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap moderate scars: 7X7 mm tip, energy 1600-1800 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap severe scars: 7X7 mm tip, 1800-2000 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap | Device: Alma - Harmony XL Laser<br>* The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.<br>* Other names: Modified Alma Laser Harmony Neodymium-Doped Yttrium Aluminium Garnet (Nd:YAG) Module;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood flow | Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of blood flow (proportion of signals with strong dynamic signal (%)/depth (mm)). | During 8 weeks | 
| Change in epidermal thickness | Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm). | During 8 weeks | 
| Change in collagen content | OCT will be used to qualitatively measure changes in facial atrophic acne scars in terms of collagen content. Collagen content will be measured in terms of brightness of OCT scan. Areas of skin that contain collagen tend to be brighter (more white in color) whereas areas with less collagen content tend to be darker. | During 8 weeks | 
| Change in skin roughness | OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm). | During 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Patient Scar Assessment Scale | Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient. | During 8 weeks | 
| The Observer Scar Assessment Scale | Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist. | During 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser, Er:YAG laser, acne, acne vulgaris, optical coherence tomography