Laser Treated Scars and Optical Coherence Tomography (OCT)

NCT05166395 | Withdrawn FDA Device

• 1 other identifier: 20190751
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Scar

Keywords

surgical scar

Outcome Measures

Primary Outcomes (5)

• POSAS Scar Assessment

  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

  As measured using optical coherence tomography

  Up to 13 weeks

• Surgical Scar Skin Roughness

  As measured using optical coherence tomography

  Up to 13 weeks

• Surgical Scar Collagen Content

  As measured using optical coherence tomography

  Up to 13 weeks

• Surgical Scar Epidermal Thickness

  As measured using optical coherence tomography

  Up to 13 weeks

Secondary Outcomes (1)

• Incidence of Adverse Events

  Up to 13 weeks

Study Arms (2)

Er:YAG laser Group

EXPERIMENTAL

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

Control (No Intervention) Group

NO INTERVENTION

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

Interventions

Er:YAG laser DEVICE

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.

Er:YAG laser Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Keyvan Nouri, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)