Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure

NCT ID: NCT03315286

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2019-03-31

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.

Conditions

Skin Cancer; Actinic Keratoses; Ultraviolet-Induced Change in Normal Skin; Behavior, Health; Behavior, Risk Reduction

Keywords

ultraviolet light; dosimetry; actinic keratosis; skin cancer; sun counseling; wearable device

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

SHADE Ultraviolet Sensor

Intervention Type: DEVICE

Patients will wear device for 6 months in addition to their own method of photo-protection.

Standard of care counseling

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Standard of care counseling

Intervention Type: BEHAVIORAL

Patients will use their own method of photo-protection

Interventions

SHADE Ultraviolet Sensor

Patients will wear device for 6 months in addition to their own method of photo-protection.

Intervention Type: DEVICE

Standard of care counseling

Patients will use their own method of photo-protection

Intervention Type: BEHAVIORAL

Other Intervention Names

SHADE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YouV Labs Inc.

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Varghese, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38495115 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HHSn261201700005c

Identifier Type: OTHER

Identifier Source: secondary_id

1609017593

Identifier Type: -

Identifier Source: org_study_id