Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

• ClinicalTrials.gov Identifier: NCT03315286
• Recruitment Status: Completed
• First Posted: October 20, 2017
• Results First Posted: November 7, 2019
• Last Update Posted: December 18, 2019
• Sponsor: Weill Medical College of Cornell University
• Collaborator: YouV Labs Inc.
• Information provided by (Responsible Party): Weill Medical College of Cornell University

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Conditions: Skin Cancer; Actinic Keratoses; Ultraviolet-Induced Change in Normal Skin; Behavior, Health; Behavior, Risk Reduction
• Interventions: Device: SHADE Ultraviolet Sensor; Behavioral: Standard of care counseling
• Enrollment: 111

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.
Pre-assignment Details

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
Reason Not Completed
Lost to Follow-up	0	3
Withdrawal by Subject	1	0
Protocol Violation	0	1

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 Number of Baseline Participants		50	47	97
Baseline Analysis Population Description		We are posting the results of patients without a transplant (97).
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	47 participants	97 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	25 50.0%	12 25.5%	37 38.1%
	>=65 years	25 50.0%	35 74.5%	60 61.9%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	47 participants	97 participants
	Female	14 28.0%	20 42.6%	34 35.1%
	Male	36 72.0%	27 57.4%	63 64.9%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	47 participants	97 participants
	Hispanic or Latino	2 4.0%	0 0.0%	2 2.1%
	Not Hispanic or Latino	45 90.0%	47 100.0%	92 94.8%
	Unknown or Not Reported	3 6.0%	0 0.0%	3 3.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants	47 participants	97 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	49 98.0%	47 100.0%	96 99.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 2.0%	0 0.0%	1 1.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	50 participants	47 participants	97 participants
		50	47	97
Baseline measurement of Actinic keratosis [1]; Mean (Full Range); Unit of measure: Lesions
	Number Analyzed	50 participants	47 participants	97 participants
		6.42; (0 to 36)	6.212; (0 to 25)	6.319; (0 to 36)
		[1] Measure Analysis Population Description: We measured only the non transplant patients (97). 14 were excluded from baseline analysis.

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
Overall Number of Participants Analyzed	49	43
Mean (Full Range); Unit of Measure: lesions
	4.53; (0 to 14)	4.74; (0 to 22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	49	43
Mean (Full Range); Unit of Measure: lesions
	0.04; (0 to 1)	0.232; (0 to 2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Device: SHADE Ultraviolet Sensor, Standard of Care Counseling
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.03
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	49	43
Mean (Full Range); Unit of Measure: units on a scale
baseline	44.2; (38 to 62)	43.6; (38 to 55)
6 months	45.3; (38 to 62)	43.7; (38 to 59)

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	49	43
Mean (Full Range); Unit of Measure: units on a scale
baseline	46.2; (37 to 63)	44.1; (37 to 65)
6 months	46.3; (37 to 66)	44.7; (37 to 63)

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	49	43
Mean (Full Range); Unit of Measure: units on a scale
baseline	57; (34 to 65)	60; (44 to 65)
6 months	55.8; (36 to 65)	62.1; (47 to 65)

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.07
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0002
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

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
Overall Number of Participants Analyzed	49	43
Measure Type: Number; Unit of Measure: lesions
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 (%)	Affected / at Risk (%)
Total	0/50 (0.00%)	0/47 (0.00%)
Serious Adverse Events
	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/50 (0.00%)	0/47 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Device: SHADE Ultraviolet Sensor	Standard of Care Counseling
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/50 (0.00%)	0/47 (0.00%)

Limitations and 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.

Results Point of Contact

• Name/Title: Dr. George Varghese, Principal Investigator
• Organization: Weill Cornell Medicine
• Phone: 646-962-3376
• EMail: giv9006@med.cornell.edu

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03315286
• Other Study ID Numbers: 1609017593; HHSn261201700005c ( Other Identifier: National Institute of Health )
• First Submitted: October 11, 2017
• First Posted: October 20, 2017
• Results First Submitted: September 4, 2019
• Results First Posted: November 7, 2019
• Last Update Posted: December 18, 2019