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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

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.

Condition or disease Intervention/treatment Phase
Skin Cancer Actinic Keratoses Ultraviolet-Induced Change in Normal Skin Behavior, Health Behavior, Risk Reduction Device: SHADE Ultraviolet Sensor Behavioral: Standard of care counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Actual Study Start Date : October 11, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 31, 2019

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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315286


Locations
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United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10024
Sponsors and Collaborators
Weill Medical College of Cornell University
YouV Labs Inc.
Investigators
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Principal Investigator: George Varghese, MD Weill Medical College of Cornell University
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03315286    
Other Study ID Numbers: 1609017593
HHSn261201700005c ( Other Identifier: National Institute of Health )
First Posted: October 20, 2017    Key Record Dates
Results First Posted: November 7, 2019
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Keywords provided by Weill Medical College of Cornell University:
ultraviolet light
dosimetry
actinic keratosis
skin cancer
sun counseling
wearable device
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Neoplasms
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Site