Laser Treated Scars and Optical Coherence Tomography (OCT)

February 16, 2024 updated by: Keyvan Nouri, University of Miami

Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Er:YAG laser Group
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.
Device: Er:YAG laser
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.
No Intervention: Control (No Intervention) Group
The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POSAS Scar Assessment
Time Frame: Up to 13 weeks
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Up to 13 weeks
Surgical Scar Blood Flow
Time Frame: Up to 13 weeks
As measured using optical coherence tomography
Up to 13 weeks
Surgical Scar Skin Roughness
Time Frame: Up to 13 weeks
As measured using optical coherence tomography
Up to 13 weeks
Surgical Scar Collagen Content
Time Frame: Up to 13 weeks
As measured using optical coherence tomography
Up to 13 weeks
Surgical Scar Epidermal Thickness
Time Frame: Up to 13 weeks
As measured using optical coherence tomography
Up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Up to 13 weeks
Adverse events reported by participant and evaluated by treating physician
Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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