NCT05481073

Brief Summary

To validate the use of Ultraviolet (UV) radiation sensor in patients with actinic keratosis, to identify barriers to its use in prospective longitudinal studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

June 22, 2022

Last Update Submit

November 11, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • QOL UV sensor

    Questionnaire will be carried out to qualitatively evaluate different aspects of the usability of the UV device, Minimum Value 0; Maximun Value 20, where higher value is the better.

    Up to week 4

Interventions

UV sensorDEVICE

Use of UV sensor to be informed about the sun exposure daily through a mobile application

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-hospitalized patients routinely seen in dermatology outpatient clinics who meet the inclusion criteria will be offered the possibility of participating in the study.

You may qualify if:

  • \>=65 years presenting actinic keratosis on scalp and/or face

You may not qualify if:

  • Patients who, due to health problems or lifestyle habits, do not expose themselves regularly to UV radiation (outdoor) for at least one hour a day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermatology Unit (Hospital Clinic)

Barcelona, Spain

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

August 1, 2022

Study Start

June 13, 2022

Primary Completion

August 2, 2022

Study Completion

September 1, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations