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

Sponsor
University of Miami (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03333759
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
4
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Alma - Harmony XL Laser
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Atrophic Facial Acne Scars With Er:YAG Laser Examined Under Optical Coherence Tomography
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)).

    2. 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).

    3. 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.

    4. 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

    1. The Patient Scar Assessment Scale [During 8 weeks]

      Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient.

    2. The Observer Scar Assessment Scale [During 8 weeks]

      Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sylvester Comprehensive Cancer Center Miami Florida United States 33130

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Keyvan Nouri, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keyvan Nouri, Doctor of Medicine, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03333759
    Other Study ID Numbers:
    • 20170490
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Jul 26, 2018
    Last Verified:
    Jul 1, 2018
    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
    Keywords provided by Keyvan Nouri, Doctor of Medicine, University of Miami
    laser
    Er:YAG laser
    acne
    acne vulgaris
    optical coherence tomography
    Additional relevant MeSH terms:
    Acne Vulgaris

    Study Results

    No Results Posted as of Jul 26, 2018