Clinical trial · Interventional
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
NCT03315286CI-TRIAL-00042400completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Behavior, Health | — | UNRESOLVED | — |
| Behavior, Risk Reduction | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Ultraviolet-Induced Change in Normal Skin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHADE Ultraviolet Sensor | Device | — | UNRESOLVED |
| Standard of care counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Device: SHADE Ultraviolet Sensor
- description
- 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
- interventionNames
- Device: SHADE Ultraviolet Sensor
- Behavioral: Standard of care counseling
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care Counseling
- description
- Patients will receive clinical counseling by their dermatologist regarding sun protection and avoidance
- interventionNames
- Behavioral: Standard of care counseling
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDumont 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 38495115