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

NCT ID: NCT03333759

Last Updated: 2018-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Alma - Harmony XL Laser

Intervention Type DEVICE

The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.

Interventions

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Alma - Harmony XL Laser

The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Keyvan Nouri

Doctor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keyvan Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20170490

Identifier Type: -

Identifier Source: org_study_id

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