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UV Sensor in Patients With Actinic Keratosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05481073
Recruitment Status : Completed
First Posted : August 1, 2022
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Almirall, S.A.

Study Description
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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
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
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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 : June 13, 2022
Actual Primary Completion Date : August 2, 2022
Actual Study Completion Date : September 1, 2022
Groups and Cohorts
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Intervention Details:
  • Device: UV sensor
    Use of UV sensor to be informed about the sun exposure daily through a mobile application

Outcome Measures
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Primary Outcome Measures :
  1. QOL UV sensor [ Time Frame: 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
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05481073


Locations
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Spain
Dermatology Unit (Hospital Clinic)
Barcelona, Spain
Sponsors and Collaborators
Almirall, S.A.
More Information
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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT05481073    
Other Study ID Numbers: Usability UV sensor study
First Posted: August 1, 2022    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms