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Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315286
Recruitment Status : Completed
First Posted : October 20, 2017
Results First Posted : November 7, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
YouV Labs Inc.
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE October 20, 2017
Results First Submitted Date  ICMJE September 4, 2019
Results First Posted Date  ICMJE November 7, 2019
Last Update Posted Date December 18, 2019
Actual Study Start Date  ICMJE October 11, 2017
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
Quantification of actinic keratosis after using the UV sensor vs. control group [ Time Frame: 1 year ]
Clinical counting of new actinic keratosis at 3 month intervals for 12 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group [ Time Frame: 6 months ]
    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.
  • Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression [ Time Frame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported ]
    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.
  • Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety [ Time Frame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported ]
    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.
  • Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities [ Time Frame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported ]
    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.
  • Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2017)
  • Quantification of squamous cell carcinoma after using the UV sensor vs. control group [ Time Frame: 1 year ]
    Clinical counting of new squamous cell carcinomas at 3 month intervals for 12 months
  • Quantification of basal cell carcinoma after using the UV sensor vs. control group [ Time Frame: 1 year ]
    Clinical counting of new basal cell carcinomas at 3 month intervals for 12 months
  • Quantification of melanoma after using the UV sensor vs. control group [ Time Frame: 1 year ]
    Clinical counting of new melanomas at 3 month intervals for 12 months
  • Assess the impact of UV sensor (SHADE) on patient's quality of life. [ Time Frame: 1 year ]
    We will assess the impact of the wearable UV device on patient's quality of life assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) computer adaptive tests. Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities
  • Assessment of cyclobutane pyrimidine dimers in sun damaged skin and sun protected skin after using the UV sensor vs. control group [ Time Frame: 1 year ]
    Quantify the impact of Shade on skin DNA damage approximated by the assessment of cyclobutane pyrimidine dimers by digital photography by ELISA at 3, 6, 9, and 12 months after enrollment
  • Observations of UV sensor (SHADE) usage over the year [ Time Frame: 1 year ]
    Assess sensor usage in the study patient population and compare characteristics in observant vs non-observant and responsive vs non-responsive patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Official Title  ICMJE Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Skin Cancer
  • Actinic Keratoses
  • Ultraviolet-Induced Change in Normal Skin
  • Behavior, Health
  • Behavior, Risk Reduction
Intervention  ICMJE
  • Device: SHADE Ultraviolet Sensor
    Patients will wear device for 6 months in addition to their own method of photo-protection.
    Other Name: SHADE
  • Behavioral: Standard of care counseling
    Patients will use their own method of photo-protection
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: SHADE Ultraviolet Sensor
    • Behavioral: Standard of care counseling
  • Active Comparator: Standard of Care Counseling
    Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance
    Intervention: Behavioral: Standard of care counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2018)
111
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2017)
120
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03315286
Other Study ID Numbers  ICMJE 1609017593
HHSn261201700005c ( Other Identifier: National Institute of Health )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Time Frame: 1-5 years
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.
Current Responsible Party Weill Medical College of Cornell University
Original Responsible Party George I. Varghese, Weill Medical College of Cornell University, Assistant Attending in Dermatology
Current Study Sponsor  ICMJE Weill Medical College of Cornell University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE YouV Labs Inc.
Investigators  ICMJE
Principal Investigator: George Varghese, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP