An interventional study of Optical Coherence Tomography in Port-Wine Stain, Rosacea and Telangiectasia, sponsored by University of California, Irvine. Terminated at 1 site in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Treatment
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.
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.
45 studies on the registry are indexed under Port-Wine Stain; 7 are open to participants now.
This study's enrollment of 55 is above the median of 29 across 30 interventional studies indexed under Port-Wine Stain.
Browse Port-Wine Stain studies →University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Subjects must meet the following inclusion criteria:
Any of the following will exclude participation in the study:
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
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
Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
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
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
| Milestone | Prospective Study Group | Prospective Control Group |
|---|---|---|
| Started | 55 | 0 |
| Completed | 0 | 0 |
| Not completed | 55 | 0 |
| Withdrew: Lost to follow-up | 55 | 0 |
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).
No measurements were reported for this outcome.
Any adverse effects of treatment such as scarring, blistering, bruising, and scabbing.
| Participants | Prospective Study Group | Prospective Control Group |
|---|---|---|
| Number of Participants With Scarring, Blistering, Bruising, and Scabbing | 0 | 0 |
Collected over From baseline to study completion, on average 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prospective Study Group | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Prospective Control Group | — | — | — |
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. The preoperative photographs could not be compared to the postoperative photographs since the subjects could not be followed.
| Age, Categorical(Participants) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| <=18 years | 8 | — | 8 |
| Between 18 and 65 years | 38 | — | 38 |
| >=65 years | 9 | — | 9 |
| Age, Continuous(years) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| Mean | 46 (4 to 89) | — | 46 (4 to 89) |
| Sex: Female, Male(Participants) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| Female | 45 | 0 | 45 |
| Male | 10 | 0 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 15 | — | 15 |
| Unknown or Not Reported | 40 | — | 40 |
| Race (NIH/OMB)(Participants) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 0 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 40 | 0 | 40 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 0 | 7 |
| Region of Enrollment(participants) | Prospective Study Group | Prospective Control Group | Total |
|---|---|---|---|
| United States | 55 | — | 55 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — All co-researchers and research personnel only on this IRB protocol will have access to IPD.
Ran from Sep 2019 to primary completion in Jul 2022, 33 months.
Results were first posted in Jan 2024, 1 year 6 months after primary completion.
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