UV Sensor in Patients With Actinic Keratosis

• Sponsor: Almirall, S.A. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05481073
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 2.6
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratosis, Actinic	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 Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pilot Feasibility Study of Using UV Sensor in Patients With Actinic Keratosis
• Actual Study Start Date: Jun 13, 2022
• Anticipated Primary Completion Date: Aug 2, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Outcome Measures

Primary Outcome Measures

1. QOL UV sensor [Up to week 4]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Unit (Hospital Clinic)	Barcelona		Spain

Sponsors and Collaborators

• Almirall, S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Almirall, S.A.
• ClinicalTrials.gov Identifier: NCT05481073
• Other Study ID Numbers: Usability UV sensor study
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis

Study Results

No Results Posted as of Aug 3, 2022