Skin and Connective Tissue Diseases

All Conditions

Heart and Blood Diseases

Neoplasms

Diseases and Abnormalities at or Before Birth

Rosacea

Telangiectasis

Hemangioma

Hemangioma, Capillary

Port-Wine Stain

Skin Diseases

Vascular Diseases

Congenital Abnormalities

Skin Abnormalities

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

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.

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

Optical Coherence Tomography

Kristen M Kelly, MD

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.

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

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.

Skin Imaging to Inform Laser Treatments

All co-researchers and research personnel only on this IRB protocol will have access to IPD.

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

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).

University of California, Irvine

Professor of Dermatology

Number of subjects at risk for adverse events is 55. 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.

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.

Prospective Study 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.

Prospective Control Group

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

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.

Kristen Kelly, MD

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.

Assessment of Change in Photographed Lesion

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.

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

Overall Study

Symptoms and General Pathology

Sclerosis

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Nitrous Oxide

Sclerosing Solutions

It is performed by a radiologist technologist who has been trained in Ericksonian hypnoanalgesia in the Hospices Civils de Lyon and has been practicing it regularly for 1 year.

The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)

The running of a hypnosis session is protocolized and is based on three times:

* The hypnotic induction time that allows to move from the state of consciousness to a modified state of consciousness: it will be adapted according to the patient as specified by the procedure of Ericksonian hypnosis. It varies from a few seconds to 10 minutes. Induction time depends on the patient's level of stress, apprehension, subsequent experiences of hospitalization, history, and level of hypnotizability.
* The dissociation time. It is the state of modified consciousness obtained at the end of the induction which is prolonged,
* The time of "return". It is time that allows the patient to regain his classic state of consciousness.

Hypnoanalgesia group

The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) throughout the procedure.

For optimal use, the beginning of its administration by the radiological technologist is performed 3 minutes before the sclerosant injection (at the end of the locating ultrasound). The end of administration will correspond to the end of the injections of the sclerosing product. These sclerosing products are not considered experimental or ancillary products in this study.

Meopa Group

Claire BENOIT-RUBY

Adeline Mansuy

This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

Comparison of the pain score felt by the child during the procedure (score 0 or 1, absence or presence of pain, on an Analog Visual Scale (EVA)) between the MEOPA group and the hypnoanalgesia group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Skin Imaging to Inform Laser Treatments	NCT04336163	Port-Wine Stain Rosacea Telangiectasia Angioma	Optical Coheren...	4 Years -	University of California, Irvine
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology	NCT03674346	Angioma	Hypnoanalgesia ... Meopa Group	7 Years - 18 Years	Hospices Civils de Lyon
Skin Imaging to Inform Laser Treatments	NCT04336163	Port-Wine Stain Rosacea Telangiectasia Angioma	Optical Coheren...	4 Years -	University of California, Irvine

Spots Global Cancer Trial Database for angioma

Every month we try and update this database with for angioma cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for angioma

Every month we try and update this database with for angioma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for angioma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.