Actinic Keratoses, Behavior, Health, Behavior, Risk Reduction, Skin Cancer, Ultraviolet-Induced Change in Normal Skin
Conditions
Keywords
ultraviolet light, dosimetry, actinic keratosis, skin cancer, sun counseling, wearable device
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.
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.
Interventions
DEVICESHADE Ultraviolet Sensor
Patients will wear device for 6 months in addition to their own method of photo-protection.
BEHAVIORALStandard of care counseling
Patients will use their own method of photo-protection
Sponsors
YouV Labs Inc.
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 47 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Standard of Care Counseling | Total | Device: SHADE Ultraviolet Sensor |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 60 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 37 Participants | 25 Participants |
| Baseline measurement of Actinic keratosis | 6.212 lesions | 6.319 lesions | 6.42 lesions |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants | 92 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 47 Participants | 96 Participants | 49 Participants |
| Region of Enrollment United States | 47 participants | 97 participants | 50 participants |
| Sex: Female, Male Female | 20 Participants | 34 Participants | 14 Participants |
| Sex: Female, Male Male | 27 Participants | 63 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 47 |
| other Total, other adverse events | 0 / 50 | 0 / 47 |
| serious Total, serious adverse events | 0 / 50 | 0 / 47 |
Outcome results
Primary
Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group | 4.53 lesions |
| Standard of Care Counseling | Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group | 4.74 lesions |
p-value: 0.8t-test, 2 sided
Secondary
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Device: SHADE Ultraviolet Sensor | 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 |
| Device: SHADE Ultraviolet Sensor | 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 |
| Standard of Care Counseling | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities | baseline | 60 units on a scale |
| Standard of Care Counseling | 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 | 62.1 units on a scale |
Comparison: baseline data is reported herep-value: 0.07t-test, 2 sided
Comparison: 6 month data is reported herep-value: 0.0002t-test, 2 sided
Secondary
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Device: SHADE Ultraviolet Sensor | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety | baseline | 46.2 units on a scale |
| Device: SHADE Ultraviolet Sensor | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety | 6 months | 46.3 units on a scale |
| Standard of Care Counseling | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety | baseline | 44.1 units on a scale |
| Standard of Care Counseling | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety | 6 months | 44.7 units on a scale |
Comparison: Baseline data is reported here.p-value: 0.2t-test, 2 sided
Comparison: 6 month data is reported herep-value: 0.4t-test, 2 sided
Secondary
Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Device: SHADE Ultraviolet Sensor | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression | baseline | 44.2 units on a scale |
| Device: SHADE Ultraviolet Sensor | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression | 6 months | 45.3 units on a scale |
| Standard of Care Counseling | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression | baseline | 43.6 units on a scale |
| Standard of Care Counseling | Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression | 6 months | 43.7 units on a scale |
Comparison: Baseline results are reported here.p-value: 0.6t-test, 2 sided
Comparison: 6 month data is reported herep-value: 0.3t-test, 2 sided
Secondary
Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Device: SHADE Ultraviolet Sensor | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | baseline | 0 lesions |
| Device: SHADE Ultraviolet Sensor | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 3 months | 0 lesions |
| Device: SHADE Ultraviolet Sensor | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 6 months | 0 lesions |
| Standard of Care Counseling | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | baseline | 1 lesions |
| Standard of Care Counseling | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 3 months | 1 lesions |
| Standard of Care Counseling | Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 6 months | 1 lesions |
Secondary
Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
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
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Device: SHADE Ultraviolet Sensor | Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 0.04 lesions |
| Standard of Care Counseling | Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 0.232 lesions |
p-value: 0.03t-test, 2 sided