search
Back to results

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

Primary Purpose

Acne Vulgaris

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alma - Harmony XL Laser
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring laser, Er:YAG laser, acne, acne vulgaris, optical coherence tomography

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sylvester Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laser Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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)).
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).
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.
Change in skin roughness
OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2017
Last Updated
July 24, 2018
Sponsor
University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT03333759
Brief Title
Treatment of Acne Scars With Erbium:Yttrium Aluminum Garnet (Er:YAG) Laser Examined Under OCT
Official Title
Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Difficult recruiting participants
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
laser, Er:YAG laser, acne, acne vulgaris, optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Alma - Harmony XL Laser
Other Intervention Name(s)
Modified Alma Laser Harmony Neodymium-Doped Yttrium Aluminium Garnet (Nd:YAG) Module
Intervention Description
The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.
Primary Outcome Measure Information:
Title
Change in blood flow
Description
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)).
Time Frame
During 8 weeks
Title
Change in epidermal thickness
Description
Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm).
Time Frame
During 8 weeks
Title
Change in collagen content
Description
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.
Time Frame
During 8 weeks
Title
Change in skin roughness
Description
OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).
Time Frame
During 8 weeks
Secondary Outcome Measure Information:
Title
The Patient Scar Assessment Scale
Description
Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient.
Time Frame
During 8 weeks
Title
The Observer Scar Assessment Scale
Description
Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist.
Time Frame
During 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs