An interventional study of SHADE Ultraviolet Sensor and Standard of care counseling in Skin Cancer, Actinic Keratoses and Ultraviolet-Induced Change in Normal Skin, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention
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.
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.
604 studies on the registry are indexed under Skin Neoplasms; 126 are open to participants now.
This study's enrollment of 111 is above the median of 55 across 408 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Exclusion Criteria:
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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 · Behavioral: Standard of care counseling
Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance
Behavioral: Standard of care counseling
Patients will wear device for 6 months in addition to their own method of photo-protection.
Also known as: SHADE
Patients will use their own method of photo-protection
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
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
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
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
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
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
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.
| Milestone | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| Started | 50 | 47 |
| Completed | 49 | 43 |
| Not completed | 1 | 4 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| lesions | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group | 4.53 (0 to 14) | 4.74 (0 to 22) |
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.
| lesions | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group | 0.04 (0 to 1) | 0.232 (0 to 2) |
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.
| units on a scale | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| baseline | 44.2 (38 to 62) | 43.6 (38 to 55) |
| 6 months | 45.3 (38 to 62) | 43.7 (38 to 59) |
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.
| units on a scale | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| baseline | 46.2 (37 to 63) | 44.1 (37 to 65) |
| 6 months | 46.3 (37 to 66) | 44.7 (37 to 63) |
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.
| units on a scale | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| baseline | 57 (34 to 65) | 60 (44 to 65) |
| 6 months | 55.8 (36 to 65) | 62.1 (47 to 65) |
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.
| lesions | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling |
|---|---|---|
| baseline | 0 | 1 |
| 3 months | 0 | 1 |
| 6 months | 0 | 1 |
Collected over Adverse effects were evaluated over the course of the study which was 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device: SHADE Ultraviolet Sensor | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Standard of Care Counseling | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
We are posting the results of patients without a transplant (97).
| Age, Categorical(Participants) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 12 | 37 |
| >=65 years | 25 | 35 | 60 |
| Sex: Female, Male(Participants) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| Female | 14 | 20 | 34 |
| Male | 36 | 27 | 63 |
| Ethnicity (NIH/OMB)(Participants) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 45 | 47 | 92 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 49 | 47 | 96 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| United States | 50 | 47 | 97 |
| Baseline measurement of Actinic keratosis(lesions) | Device: SHADE Ultraviolet Sensor | Standard of Care Counseling | Total |
|---|---|---|---|
| Mean | 6.42 (0 to 36) | 6.212 (0 to 25) | 6.319 (0 to 36) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data will be available through publications, presentations at scientific symposia and seminars. Efforts will be made to publish our research findings in scientific journals. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive PubMed Central. To encourage use of the data, subject level device data will be made available on request to qualified researchers including to NIH staff who agree to restrictions against public release of the data, attempts to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on the redistribution of the data to third parties, and proper acknowledgement of the data resource.
Supporting information: Study protocol
Time frame: 1-5 years
Access criteria: Requests will be made directly to SHADE by email through contact information to be provided on its web site and included in each publication based on these data. These data will be shared without fee through a single use web link which will enable the secure download of subject level device data in .csv format.
Ran from Oct 2017 to primary completion in Jan 2019, 15 months.
Results were first posted in Nov 2019, 9 months after primary completion.
Of 94 non-industry interventional studies with no phase under Skin Neoplasms, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 15 months is below that.
Counting every sponsor, half of 116 studies reached it within 27 months; a quarter within 10 and three quarters within 66.
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →