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Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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
Arm/Group Title Device: SHADE Ultraviolet Sensor Standard of Care Counseling Total
Hide 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
Hide 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.
1.Primary Outcome
Title Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device: SHADE Ultraviolet Sensor Standard of Care Counseling
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device: SHADE Ultraviolet Sensor Standard of Care Counseling
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Device: SHADE Ultraviolet Sensor Standard of Care Counseling
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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%) 
Hide 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%) 
Hide 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%) 

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. George Varghese, Principal Investigator
Organization: Weill Cornell Medicine
Phone: 646-962-3376
EMail: giv9006@med.cornell.edu
Layout table for additonal information
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