NCT03333759

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

August 1, 2017

Last Update Submit

July 24, 2018

Conditions

Acne Vulgaris

Keywords

laserEr:YAG laseracneacne vulgarisoptical coherence tomography

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • The Patient Scar Assessment Scale

    During 8 weeks

  • The Observer Scar Assessment Scale

    During 8 weeks

Study Arms (1)

Laser Treatment

EXPERIMENTAL

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

Interventions

Alma - Harmony XL LaserDEVICE

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

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should be 18-90 years of age
  • Patients should have Fitzpatrick skin types of I-III
  • Patients should have at least mild acne

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sylvester Comprehensive Cancer Center

Miami, Florida, 33130, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Keyvan Nouri, MD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

August 1, 2017

First Posted

November 7, 2017

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

US(1)