Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

Study Overview
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Brief Summary
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This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use.

Detailed Description
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The incidence of non-melanoma skin cancers, due to increased ultraviolet (UV) exposure, has increased by 300% over the past 2 decades. The innovative UV sensor, Shade, is designed to help people manage their UV exposure by quantifying their UV exposure levels through a linked smartphone application. In order to validate the effectiveness of Shade, we propose conducting a study communicating the level of UV exposure and correlating it with the development of actinic keratosis (AK), a precancerous lesion of the skin. We will recruit patients with multiple repeat AK's, as this population continues to develop AKs every year. We will include renal transplant patients. The risk of developing squamous cell carcinoma (SCC) in renal transplant patients is 65 times higher than normal patients. They are an ideal patient population for this study. We will evaluate the UV monitor's effectiveness in decreasing the number of AKs over a summer. This randomized partially blinded study will recruit 120 patients with a recent history of AK lesions and evaluate the incidence of new AKs after one summer. We will perform a control versus study group analysis. Half of the subjects (study group) will be randomly assigned to use the sensor along with its smartphone application, while the other half (control group) will receive standard of care treatment involving counseling to avoid sun exposure. Subjects will have regular standard of care visits with the dermatologist who will follow the number of actinic keratosis via clinical exam and photography. The primary outcome will be a statistically significant reduction by at least 25% of the cumulative number of newly occurred AK lesions between the control and the study group over one summer, counted at enrollment and follow-up. In subjects at one study site, skin DNA damage will also be assessed using cyclobutane pyrimidine dimers (CPD) levels measured by ELISA in both sun exposed (cheek) and sun protected skin (buccal mucosa) in both the study and control groups. Secondary outcomes will look at clinical decreases by 25% in CPD levels after using the sensor.

Official Title
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Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

Conditions
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Skin Cancer, Actinic Keratoses, Ultraviolet-Induced Change in Normal Skin, Behavior, Health, Behavior, Risk Reduction

Intervention / Treatment
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* Device: SHADE Ultraviolet Sensor
* Behavioral: Standard of care counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18-80 years of age given a diagnosis of actinic keratosis in the past year and/or has had a history of >5 actinic keratosis over the past 5 years has a compatible smartphone ((Apple version >= 7, Android version >= 4.4.2; no Jitterbug or Samsung Galaxy J3) willing to commit to dermatology visits (including standard of care visits) every 3 months for 6 months Exclusion Criteria: received UV therapy within the past 6 months work/lifestyle incompatible with wearing a UV sensor over the course of 1 year has difficulty controlling UV exposure has a medical condition judged incompatible with the study by the enrolling physician including the presence of an ICD or an existing plan for extended inpatient treatment has received field therapy (i.e., entire face or scalp) for the treatment of actinic keratosis (i.e., topical imiquimod, 5-fluorouracil, photodynamic therapy) in the past 3 months is an employee or direct relative of an employee of the investigational site or study sponsor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: SHADE Ultraviolet Sensor<br>Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance | Device: SHADE Ultraviolet Sensor<br>* Patients will wear device for 6 months in addition to their own method of photo-protection.<br>* Other names: SHADE;Behavioral: Standard of care counseling<br>* Patients will use their own method of photo-protection<br>|
| Active Comparator: Standard of Care Counseling<br>Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance | Behavioral: Standard of care counseling<br>* Patients will use their own method of photo-protection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group | Clinical counting of new actinic keratosis at 3 month intervals for a total duration of 6 months. Patient's actinic keratosis were counted at baseline (0 months), 3 months and 6 months. The average number of actinic keratosis at 6 months is only reported. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's non melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The average number of non melanoma skin cancers at 6 months is only reported. | 6 months | 
| Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression | PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. | Baseline, 3 months and 6 months. data at baseline and 6 months will be reported | 
| Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety | PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. | Baseline, 3 months and 6 months. data at baseline and 6 months will be reported | 
| Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities | PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. | Baseline, 3 months and 6 months. data at baseline and 6 months will be reported | 
| Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The number of melanoma skin cancers at each time point is reported. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultraviolet light, dosimetry, actinic keratosis, skin cancer, sun counseling, wearable device