Laser Treated Scars and Optical Coherence Tomography (OCT)

Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05166395
• Other study ID #: 20190751
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cicatrix
• Scar

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Surgical Scar Blood Flow	As measured using optical coherence tomography	Up to 13 weeks
Primary	Surgical Scar Skin Roughness	As measured using optical coherence tomography	Up to 13 weeks
Primary	Surgical Scar Collagen Content	As measured using optical coherence tomography	Up to 13 weeks
Primary	Surgical Scar Epidermal Thickness	As measured using optical coherence tomography	Up to 13 weeks
Secondary	Incidence of Adverse Events	Adverse events reported by participant and evaluated by treating physician	Up to 13 weeks