Skin DiseasesCOVIDX_EVCDAONCT06237036
Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion
An observational study of Skin Diseases and Skin Condition, run by AI Labs Group S.L at 1 site in Spain.
Trial summary
The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance. The study included 160 participants who have various skin issues, such as acne, psoriasis, or atopic dermatitis (a type of eczema). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Skin Condition
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 3 Mar 2022to 23 Oct 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. It encompassed a diverse patient cohort with a range of chronic dermatologic pathologies, providing a comprehensive representation of the population affected by these conditions.
Who may be able to join
- Patients who have provided their informed consent for participation in the study.
- Patients who demonstrate proficiency in both written and spoken Spanish or English.
- Patients who possess a smartphone, defined as a phone equipped with internet access and an integrated camera, regardless of make, model, or technical specifications.
Who cannot join
- Patients who, as determined by the investigator, did not adhere to the study procedures.
- Patients who were already utilizing the tool under investigation prior to the commencement of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner
The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance. The study included 160 participants who have various skin issues, such as acne, psoriasis, or atopic dermatitis (a type of eczema). The main questions it aims to answer are:
- Can this computer-aided diagnosis (CAD) system reliably track how a person's skin condition changes over time?
- Does using the tool lead to fewer in-person doctor visits?
- Are participants satisfied with using the tool at home?
Read more
Because this study focuses on evaluating the tool in a real-world setting, researchers did not use a comparison group.
What Participants Will Do
Participants will use a smartphone app for 6 months to help their doctors monitor their skin. They will:
- Take photos of their skin with their own smartphones and send them to their doctor through the app.
- Answer survey questions about their symptoms and how the condition affects their daily life.
- Complete surveys every two months to share if they are satisfied with the tool and if it is easy to use.
How Utility and Usability are Assessed
After the study, researchers and doctors will assess if the tool is practical and helpful for medical practice using several methods:
- Clinical Utility Questionnaire (CUS): Doctors use this to rate how well the AI tool tracks disease progression and helps them prioritize which participants need care first.
- Time Tracking: Researchers check if the tool lowers the time doctors spend on visits, allowing them to manage their workload more efficiently.
- System Usability Scale (SUS): Both doctors and participants use this to rate if the app is easy to navigate, simple to learn, and not too complex.
- Data Utility Questionnaire (DUQ): Doctors judge if the information collected by the app is useful for their regular practice and remote consultations.
Read the detailed description
Study Overview and Rationale The investigation was designed in response to the COVID-19 pandemic's disruption of dermatology care, which highlighted the need for efficient, remote tools to monitor chronic conditions like psoriasis, eczema, and acne. Current monitoring often relies on subjective human assessment; this study evaluates whether an Artificial Intelligence (AI) tool can provide more objective, continuous data from a participant's home to support clinical decision-making.
Objectives and Hypothesis Primary Objective: To validate the device's ability to reliably track the progression of chronic dermatological conditions. Success is measured by achieving a specific score on the Clinical Utility Questionnaire (CUS).
Secondary Objectives: To confirm high participant satisfaction with remote use, demonstrate a potential reduction in face-to-face consultations, and establish the device as a trustworthy monitoring system.
Hypothesis: The device can perform objective, continuous remote monitoring, increasing participant empowerment and reducing the need for frequent hospital visits.
Research Design and Methodology This is a prospective, observational, and analytical study involving a single group of participants.
Target Population: 160 adult participants (over age 18) diagnosed with chronic skin pathologies, including Psoriasis, Urticaria, Acne, Atopic Dermatitis, and others.
Duration: The total study duration was 18 months, with each participant followed for a 6-month period.
Participant Tasks:
Initial Visit: Participants are recruited, provide informed consent, and receive a study code. They capture their first photographs under medical supervision.
Remote Monitoring: At home, participants use their own smartphones to capture and transmit photos of affected areas at intervals determined by their specialist.
Questionnaires: Participants regularly complete symptoms and quality of life surveys (DLQI) within the app.
Data Quality and Statistical Analysis To ensure the integrity of the findings, the study implemented rigorous quality assurance and statistical protocols.
Quality Assurance and Monitoring
Site Monitoring: A designated independent monitor conducted reviews every 3 months (or every 5 participants) to verify data accuracy and ensure compliance with the Clinical Investigation Plan (CIP) and ISO 14155:2020 standards.
Data Validation: Computer filters automatically identify missing values or inconsistencies, while manual editing is used to detect logical errors.
Source Data Verification (SDV): The sponsor verified anonymized source documents, such as images and clinical records, against the electronic case report forms (CRFs).
Statistical Principles
- Primary Analysis: A one-sample Student's t-test was used to compare the mean CUS scores against the target threshold of 8.0/10.
- Secondary Analysis: Qualitative variables (like "yes/no" survey responses) are analyzed using frequency distributions, while quantitative data are summarized using means, medians, and standard deviations.
- Sample Size: The sample of 6 dermatologists and 160 participants was chosen to minimize observer variability while providing enough cases for a meaningful assessment.
Ethical and Safety Considerations The study adhered to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Data Protection: All participants were assigned alphanumeric codes to ensure anonymity. All data processing complied with GDPR and Spanish data protection laws.
Safety Monitoring: The study tracked Adverse Events (AE) and Serious Adverse Events (SAE). In this investigation, no adverse events or product reactions were observed.
Device Licensing: The manufacturer (AI Labs Group S.L.) provided the device free of charge for the study, but had no access to individual participant accounts or medical information.
- Conditions
- Skin Diseases, Skin Condition
- Keywords
- Dermatology, Skin lesions, Dermatologist, Artificial Intelligence, Chronic illness
- Medical subject headings
- Skin Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with the specified chronic dermatological conditions | The study encompasses patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. Treatment Patients participating in this study did not receive any specific treatment as part of the research protocol. Concomitant Medication/Treatment Patients continued their regular prescribed medications and treatments as directed by their primary healthcare providers. No additional medications or treatments were administered as part of this study. Follow-Up Duration The follow-up period extended for seven months. Throughout this duration, patients underwent a minimum of two follow-up visits, which could be conducted either remotely or in-person, as per the study\'s protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Utility Questionnaire (CUS) Score
The Clinical Utility Questionnaire (CUS) is a 13-item instrument assessing the practical value of the Legit.Health Plus device.
Scale Ranges: Items 1-10 use a 0-10 Likert scale (0=lowest utility, 10=highest). Items 11-12 are binary, scored as 0 (No) or 10 (Yes). Item 13 is categorical, scored as 0, 4, 8, or 10 based on the amount of consultation time saved.
Calculation Method: The Total Raw Score is the sum of all 13 items (Minimum: 0; Maximum: 130). This raw sum is normalized to a 10-point scale using the formula: (Total Raw Score / 130) × 10.
Interpretation: The final result is reported as a score from 0 to 10. Higher scores indicate greater perceived clinical utility. A score of 8.0 or higher was the pre-specified threshold for successful validation of the device's utility.
Measured: At the conclusion of the study evaluation period, up to 18 months.
Secondary outcomes (3)
System Usability Scale (SUS) Score
The System Usability Scale (SUS) is a standardized 10-item survey used to evaluate the usability and learnability of the Legit.Health Plus medical device.
Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Calculation Method: To calculate the SUS score, individual item responses are transformed into a 0-4 scale. For odd-numbered items (1, 3, 5, 7, 9), the score is the scale position minus 1. For even-numbered items (2, 4, 6, 8, 10), the score is 5 minus the scale position. The sum of these ten transformed scores is then multiplied by 2.5 to normalize the total result to a 10-point scale.
Formula: (Sum of Transformed Item Scores) × 2.5.
Interpretation: The final score ranges from 0 to 10. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability.
Measured: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
Patient Satisfaction Questionnaire Score
This 8-item questionnaire assesses user experience and satisfaction with the Legit.Health Plus device for remote monitoring.
Scale Ranges: Each of the 8 items (e.g., ease of use, empowerment, and support) is rated on a Likert scale from 0 to 10. For most items, 0 represents the lowest level of satisfaction (e.g., "Very difficult" or "Strongly disagree") and 10 represents the highest (e.g., "Very easy" or "Strongly agree").
Calculation Method: The total score is the arithmetic mean of the responses to the 8 individual items. The sum of all item scores is divided by 8 to produce a single value.
Interpretation: The final score ranges from 0 to 10. Higher scores indicate greater patient satisfaction with the remote monitoring system and the care received through the application.
Measured: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
Utility Questionnaire (DUQ) Score
The Data Utility Questionnaire (DUQ) is a standardized 5-item survey used to evaluate the utility of the information provided by the Legit.Health Plus medical device in the clinical consultation.
Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Calculation Method: To calculate the DUQ score, individual item responses are transformed into a 0-4 scale. The sum of these five scores is then multiplied by 100 and divided by (5*5) to normalize the total result to a 10-point scale.
Formula: (Sum of Transformed Item Scores) × 100/(5*5).
Interpretation: The final score ranges from 0 to 100. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability.
Measured: Collected once at the end of the 6-month follow-up period for each participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start3 Mar 2022
- Primary completion23 Oct 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- AI Labs Group S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital of Torrejon, Ribera Salud Hospitals, Spain
- Responsible party
- Sponsor
- Investigators
- Marta Andreu, MD, Principal investigator, Torrejón University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237036
- Sponsor's protocol ID
- LEGIT_COVIDX_EVCDAO_2022
- Other IDs
- EUPAS108260
- Acronym
- COVIDX_EVCDAO
- Status last verified
- Feb 2026
- First submitted
- 25 Jan 2024
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Computer-Aided Diagnosis (CAD) System Utilizing Artificial Intelligence Algorithms for Continuous and Remote Monitoring of Patient Condition Severity in an Objective and Stable Manner
- ClinicalTrials.gov ID
- NCT06237036
- Acronym / sponsor ID
- COVIDX_EVCDAO / LEGIT_COVIDX_EVCDAO_2022
- Conditions
- Skin Diseases, Skin Condition
- Keywords
- Dermatology, Skin lesions, Dermatologist, Artificial Intelligence, Chronic illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AI Labs Group S.LIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital of Torrejon, Ribera Salud Hospitals, Spain
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Posted 19 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance. The study included 160 participants who have various skin issues, such as acne, psoriasis, or atopic dermatitis (a type of eczema). The main questions it aims to answer are:
- Can this computer-aided diagnosis (CAD) system reliably track how a person's skin condition changes over time?
- Does using the tool lead to fewer in-person doctor visits?
- Are participants satisfied with using the tool at home?
Because this study focuses on evaluating the tool in a real-world setting, researchers did not use a comparison group.
What Participants Will Do
Participants will use a smartphone app for 6 months to help their doctors monitor their skin. They will:
- Take photos of their skin with their own smartphones and send them to their doctor through the app.
- Answer survey questions about their symptoms and how the condition affects their daily life.
- Complete surveys every two months to share if they are satisfied with the tool and if it is easy to use.
How Utility and Usability are Assessed
After the study, researchers and doctors will assess if the tool is practical and helpful for medical practice using several methods:
- Clinical Utility Questionnaire (CUS): Doctors use this to rate how well the AI tool tracks disease progression and helps them prioritize which participants need care first.
- Time Tracking: Researchers check if the tool lowers the time doctors spend on visits, allowing them to manage their workload more efficiently.
- System Usability Scale (SUS): Both doctors and participants use this to rate if the app is easy to navigate, simple to learn, and not too complex.
- Data Utility Questionnaire (DUQ): Doctors judge if the information collected by the app is useful for their regular practice and remote consultations.
Detailed description
Study Overview and Rationale The investigation was designed in response to the COVID-19 pandemic's disruption of dermatology care, which highlighted the need for efficient, remote tools to monitor chronic conditions like psoriasis, eczema, and acne. Current monitoring often relies on subjective human assessment; this study evaluates whether an Artificial Intelligence (AI) tool can provide more objective, continuous data from a participant's home to support clinical decision-making.
Objectives and Hypothesis Primary Objective: To validate the device's ability to reliably track the progression of chronic dermatological conditions. Success is measured by achieving a specific score on the Clinical Utility Questionnaire (CUS).
Secondary Objectives: To confirm high participant satisfaction with remote use, demonstrate a potential reduction in face-to-face consultations, and establish the device as a trustworthy monitoring system.
Hypothesis: The device can perform objective, continuous remote monitoring, increasing participant empowerment and reducing the need for frequent hospital visits.
Research Design and Methodology This is a prospective, observational, and analytical study involving a single group of participants.
Target Population: 160 adult participants (over age 18) diagnosed with chronic skin pathologies, including Psoriasis, Urticaria, Acne, Atopic Dermatitis, and others.
Duration: The total study duration was 18 months, with each participant followed for a 6-month period.
Participant Tasks:
Initial Visit: Participants are recruited, provide informed consent, and receive a study code. They capture their first photographs under medical supervision.
Remote Monitoring: At home, participants use their own smartphones to capture and transmit photos of affected areas at intervals determined by their specialist.
Questionnaires: Participants regularly complete symptoms and quality of life surveys (DLQI) within the app.
Data Quality and Statistical Analysis To ensure the integrity of the findings, the study implemented rigorous quality assurance and statistical protocols.
Quality Assurance and Monitoring
Site Monitoring: A designated independent monitor conducted reviews every 3 months (or every 5 participants) to verify data accuracy and ensure compliance with the Clinical Investigation Plan (CIP) and ISO 14155:2020 standards.
Data Validation: Computer filters automatically identify missing values or inconsistencies, while manual editing is used to detect logical errors.
Source Data Verification (SDV): The sponsor verified anonymized source documents, such as images and clinical records, against the electronic case report forms (CRFs).
Statistical Principles
- Primary Analysis: A one-sample Student's t-test was used to compare the mean CUS scores against the target threshold of 8.0/10.
- Secondary Analysis: Qualitative variables (like "yes/no" survey responses) are analyzed using frequency distributions, while quantitative data are summarized using means, medians, and standard deviations.
- Sample Size: The sample of 6 dermatologists and 160 participants was chosen to minimize observer variability while providing enough cases for a meaningful assessment.
Ethical and Safety Considerations The study adhered to the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Data Protection: All participants were assigned alphanumeric codes to ensure anonymity. All data processing complied with GDPR and Spanish data protection laws.
Safety Monitoring: The study tracked Adverse Events (AE) and Serious Adverse Events (SAE). In this investigation, no adverse events or product reactions were observed.
Device Licensing: The manufacturer (AI Labs Group S.L.) provided the device free of charge for the study, but had no access to individual participant accounts or medical information.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with the specified chronic dermatological conditions | – | –The study encompasses patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. Treatment Patients participating in this study did not receive any specific treatment as part of the research protocol. Concomitant Medication/Treatment Patients continued their regular prescribed medications and treatments as directed by their primary healthcare providers. No additional medications or treatments were administered as part of this study. Follow-Up Duration The follow-up period extended for seven months. Throughout this duration, patients underwent a minimum of two follow-up visits, which could be conducted either remotely or in-person, as per the study\'s protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with any of the specified chronic dermatological conditions that meet the inclusion criteria. These patients are attended at the Dermatology Department of the Hospital Universitario de Torrejón. It encompassed a diverse patient cohort with a range of chronic dermatologic pathologies, providing a comprehensive representation of the population affected by these conditions.
Key inclusion criteria (3 listed)
- Patients who have provided their informed consent for participation in the study.
- Patients who demonstrate proficiency in both written and spoken Spanish or English.
- Patients who possess a smartphone, defined as a phone equipped with internet access and an integrated camera, regardless of make, model, or technical specifications.
Key exclusion criteria (2 listed)
- Patients who, as determined by the investigator, did not adhere to the study procedures.
- Patients who were already utilizing the tool under investigation prior to the commencement of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Utility Questionnaire (CUS) Score
Time frame: At the conclusion of the study evaluation period, up to 18 months.
The Clinical Utility Questionnaire (CUS) is a 13-item instrument assessing the practical value of the Legit.Health Plus device. Scale Ranges: Items 1-10 use a 0-10 Likert scale (0=lowest utility, 10=highest). Items 11-12 are binary, scored as 0 (No) or 10 (Yes). Item 13 is categorical, scored as 0, 4, 8, or 10 based on the amount of consultation time saved. Calculation Method: The Total Raw Score is the sum of all 13 items (Minimum: 0; Maximum: 130). This raw sum is normalized to a 10-point scale using the formula: (Total Raw Score / 130) × 10. Interpretation: The final result is reported as a score from 0 to 10. Higher scores indicate greater perceived clinical utility. A score of 8.0 or higher was the pre-specified threshold for successful validation of the device's utility.
3 secondary outcomes
System Usability Scale (SUS) Score
Time frame: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
Patient Satisfaction Questionnaire Score
Time frame: Assessed once at the conclusion of the participant's evaluation phase, at the final study visit (up to 18 months).
Utility Questionnaire (DUQ) Score
Time frame: Collected once at the end of the 6-month follow-up period for each participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Study website on RWD catalogues of EMALink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Marta Andreu, MD principal investigator
Torrejón University Hospital
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 Skin Diseases and Skin Condition, run by AI Labs Group S.L 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 3 inclusion and 2 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 19 Mar 2026. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Utility Questionnaire (CUS) Score (time frame: At the conclusion of the study evaluation period, up to 18 months.). 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 19 Mar 2026.