Keratosis, ActinicNCT05481073
UV Sensor in Patients With Actinic Keratosis
An observational study of Keratosis, Actinic, run by Almirall, S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Keratosis, Actinic
- What is being tested?
- UV sensor
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- >=65 years presenting actinic keratosis on scalp and/or face
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Keratosis, Actinic
- Being tested
- UV sensor
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV sensorDevice
Use of UV sensor to be informed about the sun exposure daily through a mobile application
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start13 Jun 2022
- Primary completion2 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- More trials run by Almirall, S.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almirall, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481073
- Sponsor's protocol ID
- Usability UV sensor study
- Status last verified
- Nov 2022
- First submitted
- 22 Jun 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Using UV Sensor in Patients With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT05481073
- Acronym / sponsor ID
- Usability UV sensor study
- Conditions
- Keratosis, Actinic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Almirall, S.A.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate the use of Ultraviolet (UV) radiation sensor in patients with actinic keratosis, to identify barriers to its use in prospective longitudinal studies.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- >=65 years presenting actinic keratosis on scalp and/or face
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UV sensorUse of UV sensor to be informed about the sun exposure daily through a mobile application | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratosis, Actinic, run by Almirall, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QOL UV sensor (time frame: Up to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.