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Laser Treated Scars and Optical Coherence Tomography (OCT)

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05166395
Enrollment
0
Registered
2021-12-21
Start date
2024-05-01
Completion date
2025-12-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scar

Keywords

surgical scar

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.

Interventions

DEVICEEr: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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POSAS Scar AssessmentUp to 13 weeksPatient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Surgical Scar Blood FlowUp to 13 weeksAs measured using optical coherence tomography
Surgical Scar Skin RoughnessUp to 13 weeksAs measured using optical coherence tomography
Surgical Scar Collagen ContentUp to 13 weeksAs measured using optical coherence tomography
Surgical Scar Epidermal ThicknessUp to 13 weeksAs measured using optical coherence tomography

Secondary

MeasureTime frameDescription
Incidence of Adverse EventsUp to 13 weeksAdverse events reported by participant and evaluated by treating physician

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026