An observational study in Skin Diseases and Skin Condition, sponsored by AI Labs Group S.L. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by AI Labs Group S.L · Observational
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:
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:
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:
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
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.
496 studies on the registry are indexed under Skin Diseases; 77 are open to participants now.
This study's enrollment of 160 is close to the median of 165 across 101 observational studies indexed under Skin Diseases.
Browse Skin Diseases studies →AI Labs Group S.L is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: At the conclusion of the study evaluation period, up to 18 months.
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.
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
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.
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
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.
Time frame: Collected once at the end of the 6-month follow-up period for each participant.
Recruitment occurred at the Hospital Universitario de Torrejón's Dermatology Department. Investigators identified eligible participants in a community healthcare setting. The recruitment period spanned 18 months, from April 13, 2022, to October 23, 2023. Researchers used the Patient Information Sheet to explain study details before obtaining informed consent. A total of 160 participants were enrolled.
| Milestone | Patients With the Specified Chronic Dermatological Conditions |
|---|---|
| Started | 160 |
| Completed | 160 |
| Not completed | 0 |
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.
| Units on a scale | Dermatologists Assessing the Device |
|---|---|
| Clinical Utility Questionnaire (CUS) Score | 7.39 ± 2.25 |
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.
| Units on a scale | Dermatologists Assessing the Device |
|---|---|
| System Usability Scale (SUS) Score | 8.70 ± 1.58 |
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.
| Units on a scale | Patients With the Specified Chronic Dermatological Conditions |
|---|---|
| Patient Satisfaction Questionnaire Score | 7.07 ± 2.83 |
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.
| Units on a scale | Dermatologists Assessing the Device |
|---|---|
| Utility Questionnaire (DUQ) Score | 87.3 ± 16.1 |
Collected over Tracked continuously from the initial enrollment visit through the 6-month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With the Specified Chronic Dermatological Conditions | 0/160 (0%) | 0/160 (0%) | 0/160 (0%) |
| Age, Continuous(Years) | Patients With the Specified Chronic Dermatological Conditions |
|---|---|
| Mean | 64 ± 19 |
| Sex: Female, Male(Participants) | Patients With the Specified Chronic Dermatological Conditions |
|---|---|
| Female | 92 |
| Male | 68 |
| Race (NIH/OMB)(Participants) | Patients With the Specified Chronic Dermatological Conditions |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Black or African American | 0 |
| White | 157 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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