Laser Treated Scars and Optical Coherence Tomography (OCT)

NCT ID: NCT05166395

Last Updated: 2024-02-20

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WITHDRAWN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

2024-05-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Er:YAG laser

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Keyvan Nouri

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keyvan Nouri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20190751

Identifier Type: -

Identifier Source: org_study_id

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