Clinical trial NCT03315286: Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Official title: Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Actinic Keratoses
Ultraviolet-Induced Change in Normal Skin
Behavior, Health
Behavior, Risk Reduction
Keywords: ultraviolet light
dosimetry
actinic keratosis
skin cancer
sun counseling
wearable device
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: YouV Labs Inc.
First posted: 2017-10-20
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
timeFrame: 6 months
Secondary outcomes:
measure: Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
timeFrame: 6 months
measure: Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression
timeFrame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported
measure: Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety
timeFrame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported
measure: Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities
timeFrame: Baseline, 3 months and 6 months. data at baseline and 6 months will be reported
measure: Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: George Varghese, MD
role: PRINCIPAL_INVESTIGATOR
References: