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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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