Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03315286
• Collaborator: YouV Labs Inc. (Other)
• Enrollment: 111
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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 for use.

Condition or Disease	Intervention/Treatment	Phase
Skin Cancer; Actinic Keratoses; Ultraviolet-Induced Change in Normal Skin; Behavior, Health; Behavior, Risk Reduction	Device: SHADE Ultraviolet Sensor; Behavioral: Standard of care counseling	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
• Actual Study Start Date: Oct 11, 2017
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device: SHADE Ultraviolet Sensor Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance	Device: SHADE Ultraviolet Sensor; Patients will wear device for 6 months in addition to their own method of photo-protection.; Other Names: SHADE ; Behavioral: Standard of care counseling; Patients will use their own method of photo-protection
Active Comparator: Standard of Care Counseling Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance	Behavioral: Standard of care counseling; Patients will use their own method of photo-protection

Outcome Measures

Primary Outcome Measures

1. Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group [6 months]

   Clinical counting of new actinic keratosis at 3 month intervals for a total duration of 6 months. Patient's actinic keratosis were counted at baseline (0 months), 3 months and 6 months. The average number of actinic keratosis at 6 months is only reported.

Secondary Outcome Measures

1. Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group [6 months]

   Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's non melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The average number of non melanoma skin cancers at 6 months is only reported.

2. Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression [Baseline, 3 months and 6 months. data at baseline and 6 months will be reported]

   PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

3. Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety [Baseline, 3 months and 6 months. data at baseline and 6 months will be reported]

   PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

4. Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities [Baseline, 3 months and 6 months. data at baseline and 6 months will be reported]

   PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.

5. Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group [6 months]

   Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The number of melanoma skin cancers at each time point is reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Medical College of Cornell University	New York	New York	United States	10024

Sponsors and Collaborators

• Weill Medical College of Cornell University
• YouV Labs Inc.

Investigators

• Principal Investigator: George Varghese, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 14, 2018

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03315286
• Other Study ID Numbers: 1609017593; HHSn261201700005c
• First Posted: Oct 20, 2017
• Last Update Posted: Dec 18, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Weill Medical College of Cornell University: ultraviolet light; dosimetry; actinic keratosis; skin cancer; sun counseling; wearable device
• Additional relevant MeSH terms: Keratosis, Actinic; Skin Neoplasms; Keratosis

Study Results

Participant Flow

Recruitment Details	We recruited 14 patients with kidney transplantation & actinic keratosis from 10/2018 to 4/2018. We recruited another 97 patients with only a history of actinic keratosis without a history of kidney transplantation between 4/2018 and 7/2018. Patient were all recruited at one academic institution. We are presenting the data of the 97 patients.

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Period Title: Overall Study
STARTED	50	47
COMPLETED	49	43
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling	Total
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection	Total of all reporting groups
Overall Participants	50	47	97
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 50%	12 25.5%	37 38.1%
>=65 years	25 50%	35 74.5%	60 61.9%
Sex: Female, Male (Count of Participants)
Female	14 28%	20 42.6%	34 35.1%
Male	36 72%	27 57.4%	63 64.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4%	0 0%	2 2.1%
Not Hispanic or Latino	45 90%	47 100%	92 94.8%
Unknown or Not Reported	3 6%	0 0%	3 3.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	49 98%	47 100%	96 99%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2%	0 0%	1 1%
Region of Enrollment (participants) [Number]
United States	50 100%	47 100%	97 100%
Baseline measurement of Actinic keratosis (lesions) [Mean (Full Range) ]
Mean (Full Range) [lesions]	6.42	6.212	6.319

Outcome Measures

1. Primary Outcome

Title	Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
Description	Clinical counting of new actinic keratosis at 3 month intervals for a total duration of 6 months. Patient's actinic keratosis were counted at baseline (0 months), 3 months and 6 months. The average number of actinic keratosis at 6 months is only reported.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
Mean (Full Range) [lesions]	4.53	4.74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
Description	Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's non melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The average number of non melanoma skin cancers at 6 months is only reported.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
Mean (Full Range) [lesions]	0.04	0.232

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression
Description	PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Time Frame	Baseline, 3 months and 6 months. data at baseline and 6 months will be reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
baseline	44.2	43.6
6 months	45.3	43.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	Baseline results are reported here.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	6 month data is reported here
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety
Description	PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Time Frame	Baseline, 3 months and 6 months. data at baseline and 6 months will be reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
baseline	46.2	44.1
6 months	46.3	44.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	Baseline data is reported here.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	6 month data is reported here
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities
Description	PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be "I felt fearful" and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Time Frame	Baseline, 3 months and 6 months. data at baseline and 6 months will be reported

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
baseline	57	60
6 months	55.8	62.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	baseline data is reported here
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	6 month data is reported here
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
Description	Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The number of melanoma skin cancers at each time point is reported.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.

Arm/Group Title	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection	Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
Measure Participants	49	43
baseline	0	1
3 months	0	1
6 months	0	1

Adverse Events

Time Frame	Adverse effects were evaluated over the course of the study which was 6 months.
Adverse Event Reporting Description	All adverse reports were reported using an adverse event case report form. These are reported immediately into the patient's file and reported to the IRB.
Arm/Group Title	Device: SHADE Ultraviolet Sensor		Standard of Care Counseling
Arm/Group Description	Patients will receive an Ultraviolet (UV) sensor that will quantify their UV exposure through a linked smartphone application. Patients will also receive clinical counseling by their dermatologist regarding sun protection and avoidance SHADE Ultraviolet Sensor: Patients will wear device for 6 months in addition to their own method of photo-protection. Standard of care counseling: Patients will use their own method of photo-protection		Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance Standard of care counseling: Patients will use their own method of photo-protection
All Cause Mortality
	Device: SHADE Ultraviolet Sensor		Standard of Care Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/47 (0%)
Serious Adverse Events
	Device: SHADE Ultraviolet Sensor		Standard of Care Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Device: SHADE Ultraviolet Sensor		Standard of Care Counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/47 (0%)

Limitations/Caveats

Transplant patient population was limited, too small a size. Ideally, we would have liked to monitor patients over 1 year. Secondary outcomes of melanomas:, could not power the statistical analysis due to small number of diagnosed melanomas.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.