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Trial record 22 of 83 for:    acne AND Acne Scars

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

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ClinicalTrials.gov Identifier: NCT03333759
Recruitment Status : Withdrawn (Difficult recruiting participants)
First Posted : November 7, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Keyvan Nouri, 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Alma - Harmony XL Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars

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 Name: Modified Alma Laser Harmony Neodymium-Doped Yttrium Aluminium Garnet (Nd:YAG) Module




Primary Outcome Measures :
  1. Change in blood flow [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During 8 weeks ]
    Scale (1-10) used to qualitatively monitor treatment and changes in scars by the patient.

  2. The Observer Scar Assessment Scale [ Time Frame: During 8 weeks ]
    Scale (1-10) used to qualitatively monitor treatment and changes in scars by the dermatologist.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333759


Locations
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United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33130
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Keyvan Nouri, MD University of Miami

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Responsible Party: Keyvan Nouri, Doctor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03333759     History of Changes
Other Study ID Numbers: 20170490
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Keyvan Nouri, University of Miami:
laser
Er:YAG laser
acne
acne vulgaris
optical coherence tomography

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases