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Validation of shade, a wearable ultraviolet light monitor, for use in kidney transplant recipients

Clinical Trial Details

The purpose of this study is to understand the impact of solar ultraviolet radiation on pre-cancerous and cancerous growths of the skin in patients following kidney transplant. This research study will evaluate if knowledge about the amount of ultraviolet (UV) radiation exposed to their skin can help patients prevent pre-cancerous growths on the skin by comparing two methods of delivering UV counseling. 

Key Eligibility: 

Inclusion Criteria 
1. Patient is 18-80 years of age? 
2. Patient received a transplant greater than 6 months ago and is taking immunosuppressive therapy? 
3. Patient was given a diagnosis of actinic keratosis in the past year and/or has had a history of 1 actinic keratosis at 5 or more visits over the past 10 years? 
4. Does the patient use a compatible smartphone? (Apple version = 7, Android version = 4.4.2) 
5. Is patient willing to commit to dermatology visits (including standard of care visits) every three months for one year? 

If any of the above answers are “no”, the subject does not qualify for this study. 

   Exclusion Criteria 

1. Has the patient received UV therapy in the past year? 
2. Is the patient’s work/lifestyle incompatible with wearing a UV sensor over the course of 1 year (i.e., construction, lifeguard)? 
3. Will the patient have difficulty controlling UV exposure (i.e. live in nursing home, extended hospitalizations)? 
4. Does the patient have 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? 
5. Has the patient 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 12 months? 
6. Is the patient an employee or direct relative of an employee of the investigational site or study sponsor? 

If any of the above answers are “yes”, the subject does not qualify for this study. 

Contact

Melissa Platt
dermresearch@med.cornell.edu
888-502-3218

Primary Investigator

George Varghese M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1609017593

ClinicalTrials.gov:

NCT03315286

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Study Type

Phase