Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

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.

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