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Laser Treated Scars and Optical Coherence Tomography (OCT)

Primary Purpose

Scar

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Er:YAG laser
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Scar focused on measuring surgical scar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults age 18 years or older
  2. Patients should have Fitzpatrick skin types of I-IV
  3. Patients should have mild to severe post-surgical scarring located on head and neck
  4. Scar lengths of at least 3 cm.
  5. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
  2. Scar size less than 3 cm in length
  3. Pregnant or lactating females
  4. Fitzpatrick skin type of V-VI
  5. Scleroderma
  6. Photosensitivity
  7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Er:YAG laser Group

Control (No Intervention) Group

Arm Description

The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval.

The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention.

Outcomes

Primary Outcome Measures

POSAS Scar Assessment
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Surgical Scar Blood Flow
As measured using optical coherence tomography
Surgical Scar Skin Roughness
As measured using optical coherence tomography
Surgical Scar Collagen Content
As measured using optical coherence tomography
Surgical Scar Epidermal Thickness
As measured using optical coherence tomography

Secondary Outcome Measures

Incidence of Adverse Events
Adverse events reported by participant and evaluated by treating physician

Full Information

First Posted
December 8, 2021
Last Updated
October 2, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05166395
Brief Title
Laser Treated Scars and Optical Coherence Tomography (OCT)
Official Title
Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar
Keywords
surgical scar

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Er:YAG laser Group
Arm Type
Experimental
Arm Description
The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval.
Arm Title
Control (No Intervention) Group
Arm Type
No Intervention
Arm Description
The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention.
Intervention Type
Device
Intervention Name(s)
Er:YAG laser
Intervention Description
2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities.
Primary Outcome Measure Information:
Title
POSAS Scar Assessment
Description
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Time Frame
Up to 13 weeks
Title
Surgical Scar Blood Flow
Description
As measured using optical coherence tomography
Time Frame
Up to 13 weeks
Title
Surgical Scar Skin Roughness
Description
As measured using optical coherence tomography
Time Frame
Up to 13 weeks
Title
Surgical Scar Collagen Content
Description
As measured using optical coherence tomography
Time Frame
Up to 13 weeks
Title
Surgical Scar Epidermal Thickness
Description
As measured using optical coherence tomography
Time Frame
Up to 13 weeks
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Adverse events reported by participant and evaluated by treating physician
Time Frame
Up to 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age 18 years or older Patients should have Fitzpatrick skin types of I-IV Patients should have mild to severe post-surgical scarring located on head and neck Scar lengths of at least 3 cm. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study Scar size less than 3 cm in length Pregnant or lactating females Fitzpatrick skin type of V-VI Scleroderma Photosensitivity Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keyvan Nouri, MD
Phone
305-243-3380
Email
knouri@med.miami.edu
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
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD
Phone
305-243-3380
Email
knouri@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Keyvan Nouri, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Laser Treated Scars and Optical Coherence Tomography (OCT)

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