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Skin Imaging to Inform Laser Treatments

Primary Purpose

Port-Wine Stain, Rosacea, Telangiectasia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Coherence Tomography
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-Wine Stain focused on measuring Optical Coherence Tomography, Pulsed Dye Laser, Port-Wine Stain, Rosacea, Telangiectasia, Angioma

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Subjects must meet the following inclusion criteria:

  • Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative.
  • Ages 4 and older. Patients younger than 4 may have difficulty cooperating with the OCT measurements because each measurement requires the patient to remain still for approximately 30 seconds.
  • Seeks and is scheduled for laser treatment of a skin lesion. Exclusion Criteria

Any of the following will exclude participation in the study:

  • Inability to understand and/or carry out subject instructions.

Sites / Locations

  • University of California, Irvine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prospective Study Group

Prospective Control Group

Arm Description

For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.

For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.

Outcomes

Primary Outcome Measures

Assessment of change in photographed lesion
Primary outcome variable includes assessment of change in photographed lesion. Two board-certified dermatologists will grade the degree of change of the photographed lesion in quartiles (no change or darkening=0-25, mild lightening=26-50, good lightening=51-75, excellent lightening=76-95, complete resolution=96-100).

Secondary Outcome Measures

Full Information

First Posted
March 18, 2020
Last Updated
July 20, 2022
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT04336163
Brief Title
Skin Imaging to Inform Laser Treatments
Official Title
Skin Imaging to Inform Laser Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
All 55 subjects enrolled in the study completed the initial study procedures, but due to the pandemic and the prolonged period where we were unable to follow up patients, we were not able to complete the aims for this protocol.
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The purpose of this research is to assist laser treatment of skin conditions by imaging the skin to obtain information about lesional skin. This is a pilot study that will explore the utility of skin imaging in guiding the laser treatment of skin lesions. This study will utilize Optical Coherence Tomography (OCT). Data acquisition of the skin will guide laser treatment by providing information on skin lesion characteristics. There have been shown to be many applications for OCT. This imaging modality has been used to examine normal skin, burn scars, hemangiomas, nevus flammeus, fibrosarcomas, rosacea, and telangiectasias. Skin conditions to be studied include vascular lesions, scars, and inflammatory conditions. Normal and lesional skin will be assessed. Currently, laser settings are selected without the assistance of imaging. Imaging with OCT provides more information about the characteristics of the skin lesion (such as lesion depth, depth of the most superficial part of the lesion, and the size and density of blood vessels), which could allow for more informed selection of laser settings to treat individual skin lesions. OCT has been used to examine laser treatments as well, but the proposed protocol would include the use of OCT to examine the stated skin lesions above before and after laser treatment in order to compare to historical/prospective controls that did not undergo OCT imaging. The goal of this study is to optimize laser treatment with the assistance of OCT and guide future laser treatments. OCT is an imaging modality that uses light to image turbid media such as living tissues, and has been successfully used to generate high resolution (~10 micron) cross-sectional images of tissue microstructure in the human retina, skin, gastrointestinal tract, and genitourinary tract. OCT systems are now commercially available for ophthalmic and dermatologic use, and there are several clinical reports on the use of OCT in the vascular system and aero digestive tract, Ophthalmology, Pleural disorder, Neural tissue, Aneurysm healing, and Oral Pathology. This device focuses low power non-laser broad band infrared light onto tissue and does not involve input of significant amounts of energy into the subject; no temperature rise occurs. Because the wavelength of light used for imaging does not have adverse tissue effects, there is no risk. Imaging with OCT provides information about the characteristics of the skin lesion (such as lesion depth, depth of the most superficial part of the lesion, and the size and density of blood vessels). OCT poses no known risks to the patients. A multitude of studies have been conducted that validate the utility of OCT in imaging many types of skin lesions. Vascular lesions formulate a good portion of skin diseases studied by OCT, which includes rosacea, port-wine stain, hemangiomas, fibrosarcomas, cherry angiomas, and telangiectasias. Other studies have examined imaging of burn scars, the micro-circulation of the skin, and vascular changes with topical medical application. In all of these studies, OCT imaging aided treatment as well as provided a method to assess treatment outcome. For port-wine stains, OCT has provided information such as vessel diameter and depth, which was discovered to be quite variable in port-wine stains, indicating that tailored laser treatments are likely to improve result. Byers et al. noted that OCT was a robust and non-invasive method for observing longitudinal dynamics of the subcutaneous microcirculation of tumors. Telangiectasias are a prominent feature of rosacea, and OCT has elucidated information about their treatment with intense-pulsed light to simply examine the effect of the treatment on the targeted lesions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain, Rosacea, Telangiectasia, Angioma
Keywords
Optical Coherence Tomography, Pulsed Dye Laser, Port-Wine Stain, Rosacea, Telangiectasia, Angioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective study on the impact of Optical Coherence Tomography in laser treatment of vascular skin conditions.
Masking
Care Provider
Masking Description
For the control group, the laser surgeon would be unaware of OCT measurements of patients in the control group and would need to rely on his/her experience and intuition to determine the laser settings to treat the patient. For the experimental group, the laser surgeon will be exposed to the OCT measurements.
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Study Group
Arm Type
Experimental
Arm Description
For the experimental group, the laser surgeon will be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on the measurements.
Arm Title
Prospective Control Group
Arm Type
Other
Arm Description
For the control group, the laser surgeon will not be exposed to the OCT measurements and will select laser settings and determine treatment parameters based on standard of care, intuition, and experience.
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography
Intervention Description
Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
Primary Outcome Measure Information:
Title
Assessment of change in photographed lesion
Description
Primary outcome variable includes assessment of change in photographed lesion. Two board-certified dermatologists will grade the degree of change of the photographed lesion in quartiles (no change or darkening=0-25, mild lightening=26-50, good lightening=51-75, excellent lightening=76-95, complete resolution=96-100).
Time Frame
Through study completion; average of one year
Other Pre-specified Outcome Measures:
Title
Number of participants with scarring, blistering, bruising, and scabbing
Description
Any adverse effects of treatment such as scarring, blistering, bruising, and scabbing.
Time Frame
Through study completion; average of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Subjects must meet the following inclusion criteria: Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative. Ages 4 and older. Patients younger than 4 may have difficulty cooperating with the OCT measurements because each measurement requires the patient to remain still for approximately 30 seconds. Seeks and is scheduled for laser treatment of a skin lesion. Exclusion Criteria Any of the following will exclude participation in the study: Inability to understand and/or carry out subject instructions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen M Kelly, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All co-researchers and research personnel only on this IRB protocol will have access to IPD.
Citations:
PubMed Identifier
29566276
Citation
Waibel JS, Holmes J, Rudnick A, Woods D, Kelly KM. Angiographic optical coherence tomography imaging of hemangiomas and port wine birthmarks. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22816. Online ahead of print.
Results Reference
result
PubMed Identifier
28095550
Citation
Waibel JS, Rudnick AC, Wulkan AJ, Holmes JD. The Diagnostic Role of Optical Coherence Tomography (OCT) in Measuring the Depth of Burn and Traumatic Scars for More Accurate Laser Dosimetry: Pilot Study. J Drugs Dermatol. 2016 Nov 1;15(11):1375-1380.
Results Reference
result
PubMed Identifier
29082084
Citation
Byers RA, Fisher M, Brown NJ, Tozer GM, Matcher SJ. Vascular patterning of subcutaneous mouse fibrosarcomas expressing individual VEGF isoforms can be differentiated using angiographic optical coherence tomography. Biomed Opt Express. 2017 Sep 19;8(10):4551-4567. doi: 10.1364/BOE.8.004551. eCollection 2017 Oct 1.
Results Reference
result
PubMed Identifier
28541265
Citation
Aldahan AS, Chen LL, Tsatalis JP, Grichnik JM. Optical Coherence Tomography Visualization of a Port-Wine Stain in a Patient With Sturge-Weber Syndrome. Dermatol Surg. 2017 Jun;43(6):889-891. doi: 10.1097/DSS.0000000000001055. No abstract available.
Results Reference
result
PubMed Identifier
26916576
Citation
Themstrup L, Ciardo S, Manfredi M, Ulrich M, Pellacani G, Welzel J, Jemec GB. In vivo, micro-morphological vascular changes induced by topical brimonidine studied by Dynamic optical coherence tomography. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):974-9. doi: 10.1111/jdv.13596. Epub 2016 Feb 25.
Results Reference
result
PubMed Identifier
27272077
Citation
Aldahan AS, Mlacker S, Shah VV, Chen LL, Nouri K, Grichnik JM. Utilization of Optical Coherence Tomography in the Evaluation of Cherry Hemangiomas. J Drugs Dermatol. 2016 Jun 1;15(6):713-4.
Results Reference
result
PubMed Identifier
27235002
Citation
Themstrup L, Welzel J, Ciardo S, Kaestle R, Ulrich M, Holmes J, Whitehead R, Sattler EC, Kindermann N, Pellacani G, Jemec GB. Validation of Dynamic optical coherence tomography for non-invasive, in vivo microcirculation imaging of the skin. Microvasc Res. 2016 Sep;107:97-105. doi: 10.1016/j.mvr.2016.05.004. Epub 2016 May 25.
Results Reference
result
PubMed Identifier
25007365
Citation
Urban J, Siripunvarapon AH, Meekings A, Kalowitz A, Markowitz O. Optical coherence tomography imaging of erythematotelangiectatic rosacea during treatment with brimonidine topical gel 0.33%: a potential method for treatment outcome assessment. J Drugs Dermatol. 2014 Jul;13(7):821-6.
Results Reference
result
PubMed Identifier
23455486
Citation
Ring HC, Mogensen M, Banzhaf C, Themstrup L, Jemec GB. Optical coherence tomography imaging of telangiectasias during intense pulsed light treatment: a potential tool for rapid outcome assessment. Arch Dermatol Res. 2013 May;305(4):299-303. doi: 10.1007/s00403-013-1331-z. Epub 2013 Mar 2.
Results Reference
result
PubMed Identifier
29611306
Citation
Mogensen M, Bojesen S, Israelsen NM, Maria M, Jensen M, Podoleanu A, Bang O, Haedersdal M. Two optical coherence tomography systems detect topical gold nanoshells in hair follicles, sweat ducts and measure epidermis. J Biophotonics. 2018 Sep;11(9):e201700348. doi: 10.1002/jbio.201700348. Epub 2018 Jun 19.
Results Reference
result
PubMed Identifier
27885682
Citation
Banzhaf CA, Thaysen-Petersen D, Bay C, Philipsen PA, Mogensen M, Prow T, Haedersdal M. Fractional laser-assisted drug uptake: Impact of time-related topical application to achieve enhanced delivery. Lasers Surg Med. 2017 Apr;49(4):348-354. doi: 10.1002/lsm.22610. Epub 2016 Nov 25.
Results Reference
result
PubMed Identifier
28213875
Citation
Olesen UH, Mogensen M, Haedersdal M. Vehicle type affects filling of fractional laser-ablated channels imaged by optical coherence tomography. Lasers Med Sci. 2017 Apr;32(3):679-684. doi: 10.1007/s10103-017-2168-z. Epub 2017 Feb 17.
Results Reference
result

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Skin Imaging to Inform Laser Treatments

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