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

Not Applicable

Withdrawn

• Conditions: Acne Vulgaris
• Interventions: Device: Alma - Harmony XL Laser

• Registration Number: NCT03333759
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-01
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26
• Study Start: 2018-08
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients should be 18-90 years of age
2. Patients should have Fitzpatrick skin types of I-III
3. Patients should have at least mild acne

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Exclusion Criteria

1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
2. Pregnant or lactating females
3. Fitzpatrick skin type of IV-VI
4. A history of keloids or hypertrophic scars
5. Scleroderma
6. Photosensitivity
7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months
8. Subjects with a known history of herpes simplex

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser Treatment	Alma - Harmony XL Laser	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

Primary Outcome Measures

Name	Time	Method
Change in epidermal thickness	During 8 weeks	Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm).
Change in collagen content	During 8 weeks	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.
Change in blood flow	During 8 weeks	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)).
Change in skin roughness	During 8 weeks	OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States