Smartphone Application to Detect Skin Lesions

Study Overview
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Brief Summary
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The primary objective of Part One of this study is to determine the sensitivity of an automated total body digital photography (TBDP) app to detect color and size changes in the human skin, and whether a new lesion has arisen. The primary objective of Part Two is to test the sensitivity and specificity as well as feasibility of field use of an automated TBDP app to detect pigmented and non-pigmented skin lesions in high risk populations.

Detailed Description
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SkinIO is an early-stage healthcare IT company specializing in education, early detection, and prevention of skin cancer. This study will utilize their product, skinIO, an enhanced full-body skin cancer screening system that works on mobile devices and tablets to track changes in skin over time without any additional imaging hardware. skinIO enables dermatology staff to photograph high-risk patients in 13 medical photography poses to quickly capture full-body skin surfaces at multiple resolutions using a mobile device. These images are automatically uploaded to a HIPAA-compliant server environment where they will be rapidly processed to detect any spots, lesions, and moles. Dermatologists will then be able to annotate these images and flag specific images for follow-up every month. In order to assess whether or not the software will accurately detect spot changes, the investigators will test the product on a sample of volunteer subjects. Part One: The study population will undergo one study visit. This visit will include 2 sets of photos taken by the research team after the collection of a small amount of identifying and contact information for each subject. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings (ie. moles, angiomas, scars, keloids, seborrheic keratosis, small tattoos, etc). These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3- 5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. These markers have been AP certified to be non-toxic. The following colors have been chosen: orange, black, brown, red, blue, purple, yellow and pink. A second photograph will be taken of the same areas of the body chosen for initial photographs to determine if the application could detect the changes. This group will not have their images sent to a dermatologist for evaluation, as they are artificially produced. Part Two: In order to test the sensitivity and feasibility of field of use of the TBDP app, a second convenience sample of patients will be recruited. Recruitment will be done in waiting rooms with the attending physician's consent. If needed, recruitment will be done outside of the waiting room in the form of flyers, website and e-mail announcements. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. Each projection corresponds to each body area that will be photographed to ensure total body photography. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. The patient will be provided a user guide with written instructions for application use. The TBDP app has a built-in reminder system for the patient. Any changes detected by the app will be stored on the research team's database. Standard of care will be followed for any new/changing lesions. Patients will be recommended to have a follow-up appointment with their dermatologist, within 2 weeks. No procedures will be completed by the research team, and a physician will not be seeing the patients during their research appointments. During these visits, the research team will compare the photographs taken by the TBDP app to the patient's skin to see how sensitive the app is. Patients will continue their regular office visits at 6 months and/or 12 months as per standard of care for high risk patients. The research team will use information from chart reviews for assessment of the outcome for new or changing lesions.

Official Title
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Skin Lesion Detection With Novel Total Body Digital Photography Smartphone Application

Conditions
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Skin Lesion

Intervention / Treatment
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* Other: Photos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females age 18 - 85. Subjects with the following skin types: Always burns, never tans or Burns easily, then develops light tan or Burns moderately, then develops light tan or Burns minimally rarely, then develops moderate tan. Subjects who deny prior skin reactions to washable markers. Subjects who have natural skin markings on at least 3 areas of their body. Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator in English. Subjects are able to complete the study procedures. Subjects are willing to have digital photos taken of them. Exclusion Criteria: Subjects who have a history of skin disease (eg. vitiligo, psoriasis) Subjects with the following skin types: Never burns, always develops a dark tan or Never burns, no noticeable change in appearance. Part Two (only): H] Subjects must be high risk. High risk is defined as subjects with conditions including, but not limited to: dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, immunosuppressed status I] Subjects must have an iPhone 4S or newer, or an iPad Air 2, iPad Mini 4 or iPad Pro in order to download and use the application and take photographs of high enough quality for the physician to analyze if needed. J] Subjects must have someone who is able to take photos of the subject every month. The designated individual may or may not be present at the initial encounter. 4.2 Exclusion Criteria A] Subjects who have a history of skin disease (eg. vitiligo, psoriasis) B] Subjects with the following skin types: Never burns, always develops a dark tan or Never burns, no noticeable change in appearance. Part Two (only) C] Subjects without the appropriate devices for app download. The appropriate devices are iPhone 4s or newer, or iPad Air 2, iPad Mini 4 or iPad Pro. D] Subjects who do not have someone who is capable of taking photos of the subject every month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 Artificial Lesions<br>Photos will be taken of skin lesion markings using a smartphone | Other: Photos<br>* Photos will be taken of skin lesion markings using a smart phone or tablet<br>|
| Group 2 high risk<br>A convenience sample of patients will be recruited. This population will consist of patients with known high risk to have new/changing lesions, and who fall within the Fitzpatrick skin types I-IV. High risk patients include, but are not limited to, those with dysplastic nevus syndrome, previous history of melanoma/non-melanoma skin cancer, fair skin, >16 nevi, family history of melanoma, and/or immunosuppressed status. The first photography session will be taken by the research team in all 13 projections. After the first visit, the patient will be instructed to take photographs every month for 12 months using the TBDP app on their smart phone or tablet, and have follow-up research appointments every 6 months. | Other: Photos<br>* Photos will be taken of skin lesion markings using a smart phone or tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of an automated total body digital photography (TBDP) | We will assess whether or not the photography software can accurately detect spot changes. We will test the product on a sample of volunteer subjects. The study population will undergo one study visit and will include 2 sets of photos. There will be an initial 3-5 photographs taken of areas of the body that have at least 3 natural or artificial skin markings. These markings will allow the app to calculate the parameters of any original lesions, and thereby more accurately detect new markings or changes based on these calculations. Once the original photographs are taken, one of each individual's original skin marking will be enhanced/enlarged with a marking pen, as well as 3-5 new marks added to the skin. A Sharpie brush tip permanent marker will be utilized to make the new skin markings. A second photograph will be taken of the same areas of the body chosen for the initial photographs in order to determine if the application could detect the changes. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of an automated total body digital photography (TBDP) in high risk subjects | Data will be compared between the last picture taken by the app before the clinic visit and the lesions seen by the clinician at the clinic visit. Total number of lesions will be those detected by the clinician, which were not present in the baseline skin evaluation. | Baseline, 6 and 12 months follow-up |