Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

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.

Study Overview

• Status: Completed
• Conditions: Skin Cancer; Actinic Keratoses; Behavior, Health; Ultraviolet-Induced Change in Normal Skin; Behavior, Risk Reduction
• Intervention / Treatment: Device: SHADE Ultraviolet Sensor; Behavioral: Standard of care counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10024
      • Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device: SHADE Ultraviolet Sensor; 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; Patients will wear device for 6 months in addition to their own method of photo-protection.; Other Names: SHADE; Behavioral: Standard of care counseling; Patients will use their own method of photo-protection
Active Comparator: Standard of Care Counseling; Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance	Behavioral: Standard of care counseling; Patients will use their own method of photo-protection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: YouV Labs Inc.
• Investigators: Principal Investigator: George Varghese, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: actinic keratosis; wearable device; skin cancer; dosimetry; ultraviolet light; sun counseling
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Precancerous Conditions; Keratosis, Actinic; Keratosis; Skin Neoplasms
• Other Study ID Numbers: 1609017593; HHSn261201700005c (Other Identifier: National Institute of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available through publications, presentations at scientific symposia and seminars. Efforts will be made to publish our research findings in scientific journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. To encourage use of the data, subject level device data will be made available on request to qualified researchers including to NIH staff who agree to restrictions against public release of the data, attempts to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on the redistribution of the data to third parties, and proper acknowledgement of the data resource.
• IPD Sharing Time Frame: 1-5 years
• IPD Sharing Access Criteria: Requests will be made directly to SHADE by email through contact information to be provided on its web site and included in each publication based on these data. These data will be shared without fee through a single use web link which will enable the secure download of subject level device data in .csv format.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No