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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Alma - Harmony XL Laser

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33130
      • Sylvester Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Laser Treatment; 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; The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.; Other Names: Modified Alma Laser Harmony Neodymium-Doped Yttrium Aluminium Garnet (Nd:YAG) Module

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (ACTUAL): November 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: optical coherence tomography; laser; acne; Er:YAG laser; acne vulgaris
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 20170490

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes