UV Sensor in Patients With Actinic Keratosis

Pilot Feasibility Study of Using UV Sensor in Patients With Actinic Keratosis

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

Study Overview

• Status: Completed
• Conditions: Keratosis, Actinic
• Intervention / Treatment: Device: UV sensor

Detailed Description

To prevent both acute and chronic damage from exposure to UV A and UV B radiation. Personal UV exposure can be assessed by portable sensors. Having an accurate awareness of one's own behavior (assessed by the accuracy of the UV sensor), can motivate and engage with skin protection.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Dermatology Unit (Hospital Clinic)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Almirall, S.A.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: Usability UV sensor study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No