N/A
N=97
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
Skin Cancer · Actinic Keratoses · Ultraviolet-Induced Change in Normal Skin · Behavior, Health · Behavior, Risk Reduction
Bottom Line
View on ClinicalTrials.gov: NCT03315286 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group — 4.53; 4.74 lesions — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SHADE Ultraviolet Sensor (Device); Standard of care counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group |
4.53; 4.74 | 0.8 |
| SECONDARY Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group |
0.04; 0.232 | 0.03 sig |
| SECONDARY Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression |
44.2; 43.6; 45.3; 43.7 | 0.6 |
| SECONDARY Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety |
46.2; 44.1; 46.3; 44.7 | 0.2 |
| SECONDARY Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities |
57; 60; 55.8; 62.1 | 0.07 |
| SECONDARY Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group |
0; 1; 0; 1; 0; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03315286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.