Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: SHADE Ultraviolet Sensor (Device)
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
干预措施: Standard of care counseling (Behavioral)
Standard of Care Counseling
Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance
干预措施: Standard of care counseling (Behavioral)
结局指标
主要结局
Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group
时间窗: 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.
次要结局
- 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)