Status:
COMPLETED
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
YouV Labs Inc.
Conditions:
Skin Cancer
Actinic Keratoses
Eligibility:
All Genders
18-80 years
Phase:
NA
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 f...
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 manag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03315286
Start Date
October 11 2017
End Date
March 31 2019
Last Update
December 18 2019
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10024