Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Condition: Skin Cancer; Actinic Keratoses; Ultraviolet-Induced Change in Normal Skin; Behavior, Health; Behavior, Risk Reduction
MeSH terms: Keratosis, Actinic; Skin Neoplasms; Keratosis
Study type: Interventional

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.
    

Intervention name(s): SHADE Ultraviolet Sensor; Standard of care counseling
Intervention type(s): Device; Behavioral
Intervention description(s): Patients will wear device for 6 months in addition to their own method of photo-protection.; Patients will use their own method of photo-protection
Other intervention name(s): SHADE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ultraviolet light; dosimetry; actinic keratosis; skin cancer; sun counseling; wearable device