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Skin Imaging to Inform Laser Treatments

NCT04336163 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-01-30

Study results available
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Summary

The purpose of this study is to obtain information (such as lesion depth, depth of the most superficial part of the lesion, and the size and density of blood vessels) with the assistance of an imaging device, and use this information to assist in selection of laser settings for the treatment of skin conditions. The imaging modality is called Optical Coherence Tomography (OCT). Multiple laser modalities will be used, including intense pulsed light lasers (BroadBand Light, Profractional Sciton), pulsed dye lasers (Vbeam Perfecta, Candela), long-pulse 755nm lasers (GentleLASE, Candela), Sciton long-pulse 1064nm lasers, and non-ablative and ablative fractional resurfacing lasers (Profractional, Sciton). All of the lasers noted above are the only ones that will be used in this study. These lasers have 510k clearance and are being used as per their approved indications in this study. The choice of laser type is based on the skin lesion and is recommended by the physician, and the subjects who are going to enroll in this study will already be planned to undergo laser treatment as a standard of care for their condition. This is a pilot study that will explore the utility of skin imaging in guiding the laser treatment of skin lesions.

Conditions

  • Port-Wine Stain
  • Rosacea
  • Telangiectasia
  • Angioma

Interventions

DEVICE

Optical Coherence Tomography

Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.

Sponsors & Collaborators

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Kristen M Kelly, MD · University of California, Irvine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2022-07-08
Completion
2022-07-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336163 on ClinicalTrials.gov