Trial Outcomes & Findings for Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure (NCT NCT03315286)
NCT ID: NCT03315286
Last Updated: 2019-12-18
Results Overview
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.
COMPLETED
NA
111 participants
6 months
2019-12-18
Participant Flow
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.
Participant milestones
| Measure |
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
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
|
Standard of Care Counseling
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 Study
STARTED
|
50
|
47
|
|
Overall Study
COMPLETED
|
49
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
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
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
|
Standard of Care Counseling
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 Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
We measured only the non transplant patients (97). 14 were excluded from baseline analysis.
Baseline characteristics by cohort
| Measure |
Device: SHADE Ultraviolet Sensor
n=50 Participants
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
|
Standard of Care Counseling
n=47 Participants
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
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
47 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Baseline measurement of Actinic keratosis
|
6.42 lesions
n=5 Participants • We measured only the non transplant patients (97). 14 were excluded from baseline analysis.
|
6.212 lesions
n=7 Participants • We measured only the non transplant patients (97). 14 were excluded from baseline analysis.
|
6.319 lesions
n=5 Participants • We measured only the non transplant patients (97). 14 were excluded from baseline analysis.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
|
4.53 lesions
Interval 0.0 to 14.0
|
4.74 lesions
Interval 0.0 to 22.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
|
0.04 lesions
Interval 0.0 to 1.0
|
0.232 lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 months. data at baseline and 6 months will be reportedPROMIS (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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression
baseline
|
44.2 units on a scale
Interval 38.0 to 62.0
|
43.6 units on a scale
Interval 38.0 to 55.0
|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression
6 months
|
45.3 units on a scale
Interval 38.0 to 62.0
|
43.7 units on a scale
Interval 38.0 to 59.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 months. data at baseline and 6 months will be reportedPROMIS (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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety
baseline
|
46.2 units on a scale
Interval 37.0 to 63.0
|
44.1 units on a scale
Interval 37.0 to 65.0
|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety
6 months
|
46.3 units on a scale
Interval 37.0 to 66.0
|
44.7 units on a scale
Interval 37.0 to 63.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months and 6 months. data at baseline and 6 months will be reportedPROMIS (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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities
baseline
|
57 units on a scale
Interval 34.0 to 65.0
|
60 units on a scale
Interval 44.0 to 65.0
|
|
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities
6 months
|
55.8 units on a scale
Interval 36.0 to 65.0
|
62.1 units on a scale
Interval 47.0 to 65.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Device: SHADE Ultraviolet Sensor
n=49 Participants
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
|
Standard of Care Counseling
n=43 Participants
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
|
|---|---|---|
|
Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
baseline
|
0 lesions
|
1 lesions
|
|
Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
3 months
|
0 lesions
|
1 lesions
|
|
Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
6 months
|
0 lesions
|
1 lesions
|
Adverse Events
Device: SHADE Ultraviolet Sensor
Standard of Care Counseling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. George Varghese, Principal Investigator
Weill Cornell Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place