Laser Treated Scars and Optical Coherence Tomography (OCT)

Not Applicable

Withdrawn

• Conditions: Scar

• Registration Number: NCT05166395
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Study Start: 2024-05-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
POSAS Scar Assessment	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).
Surgical Scar Blood Flow	Up to 13 weeks	As measured using optical coherence tomography
Surgical Scar Collagen Content	Up to 13 weeks	As measured using optical coherence tomography
Surgical Scar Skin Roughness	Up to 13 weeks	As measured using optical coherence tomography
Surgical Scar Epidermal Thickness	Up to 13 weeks	As measured using optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	Up to 13 weeks	Adverse events reported by participant and evaluated by treating physician

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States