Pilot Study: AI Algorithm for Dermatology Referral Optimization

NCT06228014 | Completed

• 1 other identifier: PS2022074
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational prospective and analytical study is to validate that the device is a valid tool for improving the adequacy of referrals to dermatology. As a secondary objectives the investigators set out to validate that the device reduces costs in secondary care; to validate that the device reduces dermatology waiting lists and to validate that the device optimizes clinical flow in Osakidetza. The primary care physician will explain to the patient what his/her participation in the study will consist of by means of the Patient Information Sheet. The patient, in turn, will be able to ask all the questions he/she considers appropriate in order to clarify all his/her doubts regarding the study. If the patient wishes to participate in the study, he/she will sign the Informed Consent Form and will be assigned a study code. After signing the informed consent, the data collection process begins. The Principal Investigator and/or collaborating investigators assigned to this task will collect demographic data (age, sex) and data related to the diagnosis, characteristics and treatment of the pathology. Primary care physicians should take photographs showing the areas affected by the pathology. These photographs will be taken with their own smartphone or using a mobile dermatoscope if the use of a mobile dermatoscope is clinically relevant. The primary care physician, will record the photographs periodically, uploading the images to a Google Drive folder that the study sponsor will enable at the beginning of the study. The photographs are named using a code that includes the patient ID (NNN) and photograph number (nn). Primary care physicians will assess the patient\'s pathology as they would in a routine consultation and record their diagnosis and referral criteria, and associate them with the patient\'s photographs and demographic data to be collected by the research team telematically at the end of the study duration. These information transfers and the storage of the photographs will be in line with the European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and the free movement of such data and the Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights. The specialist physicians will have a period of one month after the end of the recruitment period to evaluate and label the photographs taken. In this labeling process they will record their diagnosis, and whether they consider that the referral has been appropriate or not. This information will be collected by the research team telematically at the end of the study duration. This transfer of information and storage of the photographs will comply with European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and with Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights.

Conditions

Skin Diseases; Skin Condition

Keywords

Dermatology; General practitioners; Artificial Intelligence; Algorithm; Diagnostic

Outcome Measures

Primary Outcomes (1)

• Number of patients with inappropriate referrals

  We define an inappropriate referral as one that, according to the criteria of the specialists consulted in the study, does not require the attention of a dermatologist in order to be treated, as may be the case of seborrheic keratosis. For this purpose, a photograph will be taken and the date of the patient's visit to the clinic and the criteria for moving to the next stage of the care process will be recorded

  The moment of enrollment

Secondary Outcomes (5)

• Demographical Data

  The moment of enrollment

• Data on the primary care physician

  The moment of enrollment

• Cost reduction

  The moment of enrollment

• Waiting list reduction

  The moment of enrollment

• Clinical data

  The moment of enrollment

Study Arms (1)

Patients with any kind of skin pathologies

Adult patients (≥ 18 years) with skin pathologies seen in the primary care service of health centers referring to Cruces and Basurto University Hospitals. Patients participating in this study did not receive any specific treatment as part of the research protocol. 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years) with any kind of skin pathology seen in the primary care service of health centers referring to Cruces and Basurto University Hospitals.

You may qualify if:

• Patients with skin pathologies.
• Patients aged 18 years or older.
• Patients who have signed the informed consent for the study.

You may not qualify if:

• Patient who at the investigator\'s discretion will not comply with the study procedures.

Sponsors & Collaborators

• AI Labs Group S.L: lead
• Osakidetza: collaborator
• Servicio Vasco de Salud Osakidetza, Spain: collaborator
• Hospital de Cruces: collaborator

Study Sites (1)

University Hospital of Cruces

Barakaldo, Biscay, 48903, Spain

Location

MeSH Terms

Conditions

Skin Diseases; Disease

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: November 23, 2022
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

ES (1)