Skin Imaging to Inform Laser Treatments

NCT04336163 | Terminated Results DMC FDA Device

• 1 other identifier: 20195222
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Port-Wine Stain; Rosacea; Telangiectasia; Angioma

Keywords

Optical Coherence Tomography; Pulsed Dye Laser; Port-Wine Stain; Rosacea; Telangiectasia; Angioma

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion; average of one year

Other Outcomes (1)

• Number of Participants With Scarring, Blistering, Bruising, and Scabbing

  Through study completion; average of one year

Study Arms (2)

Prospective Study Group

EXPERIMENTAL

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.

Device: Optical Coherence Tomography

Prospective Control Group

OTHER

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.

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

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

Prospective Control Group; Prospective Study Group

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any of the following will exclude participation in the study:
• Inability to understand and/or carry out subject instructions.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92617, United States

Location

Related Publications (12)

• 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.

  PMID: 29566276 RESULT

• 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.

  PMID: 28095550 RESULT

• 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.

  PMID: 29082084 RESULT

• 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.

  PMID: 28541265 RESULT

• 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.

  PMID: 26916576 RESULT

• 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.

  PMID: 27272077 RESULT

• 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.

  PMID: 27235002 RESULT

• 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.

  PMID: 25007365 RESULT

• 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.

  PMID: 23455486 RESULT

• 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.

  PMID: 29611306 RESULT

• 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.

  PMID: 27885682 RESULT

• 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.

  PMID: 28213875 RESULT

MeSH Terms

Conditions

Port-Wine Stain; Rosacea; Telangiectasis; Hemangioma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Kristen Kelly, MD
• Organization: University of California, Irvine

kmkelly@uci.edu

949-824-6550

Study Officials

• Kristen M Kelly, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: A prospective study on the impact of Optical Coherence Tomography in laser treatment of vascular skin conditions.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: April 7, 2020
• Study Start: September 20, 2019
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)