Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure (NCT03315286) | Clinical Trial Compass
CompletedNot Applicable
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
United States111 participantsStarted 2017-10-11
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
Timeframe: 6 months
Trial details
NCT IDNCT03315286
SponsorWeill Medical College of Cornell University