Skip to content

Skin Imaging to Inform Laser Treatments

Skin Imaging to Inform Laser Treatments

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04336163
Enrollment
55
Registered
2020-04-07
Start date
2019-09-20
Completion date
2022-07-08
Last updated
2024-01-30

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

Conditions

Angioma, Port-Wine Stain, Rosacea, Telangiectasia

Keywords

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

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.

Interventions

DEVICEOptical Coherence Tomography

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

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Change in Photographed LesionThrough study completion; average of one yearPrimary 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).

Other

MeasureTime frameDescription
Number of Participants With Scarring, Blistering, Bruising, and ScabbingThrough study completion; average of one yearAny adverse effects of treatment such as scarring, blistering, bruising, and scabbing.

Countries

United States

Participant flow

Participants by arm

ArmCount
Prospective Study Group
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. Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
55
Prospective Control Group
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. Optical Coherence Tomography: Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
0
Total55

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up550

Baseline characteristics

CharacteristicProspective Study GroupTotalProspective Control Group
Age, Categorical
<=18 years
8 Participants8 Participants
Age, Categorical
>=65 years
9 Participants9 Participants
Age, Categorical
Between 18 and 65 years
38 Participants38 Participants
Age, Continuous46 years46 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
40 Participants40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
8 Participants8 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants7 Participants0 Participants
Race (NIH/OMB)
White
40 Participants40 Participants0 Participants
Region of Enrollment
United States
55 participants55 participants
Sex: Female, Male
Female
45 Participants45 Participants0 Participants
Sex: Female, Male
Male
10 Participants10 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 0
other
Total, other adverse events
0 / 550 / 0
serious
Total, serious adverse events
0 / 550 / 0

Outcome results

Primary

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).

Time frame: Through study completion; average of one year

Population: 55 experimental group subjects were consented to this study. However, due to the global pandemic, subjects could not come for study visits, which significantly precluded the study team from following up with the subjects for several months. Therefore, the study was terminated. Although we have preoperative photographs, we did not have postoperative photographs of the subjects because we were not able to see them in followup.

Other Pre-specified

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

Any adverse effects of treatment such as scarring, blistering, bruising, and scabbing.

Time frame: Through study completion; average of one year

Population: 55 experimental group subjects were consented to this study. However, due to the global pandemic, subjects could not come for study visits, which significantly precluded the study team from following up with the subjects for several months. Therefore, the study was terminated.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prospective Study GroupNumber of Participants With Scarring, Blistering, Bruising, and Scabbing0 Participants
Prospective Control GroupNumber of Participants With Scarring, Blistering, Bruising, and Scabbing0 Participants

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