NCT03315286

Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Skin Cancer
• Actinic Keratoses
• Ultraviolet-Induced Change in Normal Skin
• Behavior, Health
• Behavior, Risk Reduction

Interventions

Type	Name	Description
DEVICE	SHADE Ultraviolet Sensor	Patients will wear device for 6 months in addition to their own method of photo-protection.
BEHAVIORAL	Standard of care counseling	Patients will use their own method of photo-protection

Timeline

• Start date: 2017-10-11
• Primary completion: 2019-01-31
• Completion: 2019-03-31
• First posted: 2017-10-20
• Last updated: 2019-12-18
• Results posted: 2019-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study