Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
2 other identifiers
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedResults Posted
Study results publicly available
November 7, 2019
CompletedDecember 18, 2019
December 1, 2019
1.3 years
October 11, 2017
September 4, 2019
December 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (5)
Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
6 months
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
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
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
Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group
6 months
Study Arms (2)
Device: SHADE Ultraviolet Sensor
EXPERIMENTALPatients 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
Standard of Care Counseling
ACTIVE COMPARATORPatients will receive clinical counseling by their dermatologist regarding sun protection and avoidance
Interventions
Patients will wear device for 6 months in addition to their own method of photo-protection.
Patients will use their own method of photo-protection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- YouV Labs Inc.collaborator
Study Sites (1)
Weill Medical College of Cornell University
New York, New York, 10024, United States
Related Publications (1)
Dumont ELP, Kaplan PD, Do C, Banerjee S, Barrer M, Ezzedine K, Zippin JH, Varghese GI. A randomized trial of a wearable UV dosimeter for skin cancer prevention. Front Med (Lausanne). 2024 Mar 1;11:1259050. doi: 10.3389/fmed.2024.1259050. eCollection 2024.
PMID: 38495115DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Dr. George Varghese, Principal Investigator
- Organization
- Weill Cornell Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
George Varghese, MD
Weill Medical College of Cornell University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 20, 2017
Study Start
October 11, 2017
Primary Completion
January 31, 2019
Study Completion
March 31, 2019
Last Updated
December 18, 2019
Results First Posted
November 7, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
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.