Clinical Workflow Optimization Using Artificial Intelligence for Dermatological Conditions

NCT06263413 | Recruiting

• 1 other identifier: 24.12.2266-GHM
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Artificial intelligence (AI) based on imaging holds tremendous potential to enhance visual diagnostic accuracy in the medical field. Amid the COVID-19 pandemic, limited access to in-person healthcare services drove shifts in medical care, hastening the adoption of telemedicine. In this context, AI usage for triage and decision support may be crucial for professionals to manage workload and improve performance. In dermatology, pigmented lesions, acne, and alopecia are three recurring pathology groups with high demand in dermatological centers. Both triage, clinical evaluation, and patient follow-up require in-person resources and specialist dedication. Employing tools like AI can benefit these professionals in reducing such processes and optimizing workload. Advancements in image recognition and interpretation, as well as in artificial intelligence, have spurred innovations in diagnosing various pathologies, including skin conditions. Computer-Aided Diagnosis (CAD) systems and other algorithm-based technologies have demonstrated the ability to classify lesion images with a competency comparable to that of an expert physician. In this study, the Legit.Health tool, developed by AI LABS GROUP S.L., which utilizes artificial intelligence to optimize clinical flow and patient care processes for skin conditions, will be evaluated. The purpose of this tool is to automatically prioritize patients with greater urgency, assign the type of consultation (dermatological or aesthetic), enhance diagnostic capability and detection of malignant pigmented lesions in auxiliary staff, and provide a visual record (photograph) of the condition for later review by external experts. Thus, the main objective of this study is to validate that Legit.Health, based on Artificial Intelligence, improves efficiency in clinical flow and patient care processes, thereby reducing time and cost of patient care through enhanced diagnostic accuracy and severity determination. The secondary objectives focus on measuring the diagnostic performance of Legit.Health: Demonstrate that Legit.Health enhances healthcare professionals\' ability to detect malignant or suspicious pigmented lesions. Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with female androgenetic alopecia. Demonstrate that Legit.Health improves healthcare professionals\' ability and precision in measuring the degree of involvement in patients with acne. Additionally, the study aims to assess the utility of this tool: Automate the triage/initial assessment process in patients presenting with pigmented lesions. Evaluate the reduction in healthcare resources usage by the center by reducing the number of triage consultations and directing the patient directly to the appropriate consultation (esthetic or dermatological). Evaluate Legit.Health\'s usability by the patient. Demonstrate that Legit.Health increases specialist satisfaction. Evaluate the reduction in healthcare resources usage by reducing the number of triage consultations and directing the patient directly to the appropriate consultation, whether in aesthetic or dermatological settings. Methodology Study Design Type This is an observational study, both prospective with a longitudinal character and retrospective case series. Study Period This study estimates a recruitment period of 3 months. The total study duration is estimated at 6 months, including the previous time for retrospective analysis and the necessary time after recruiting the last subject for database closure and editing, data analysis, and preparation of the final study report. The total study duration for each participant with pigmented lesions will be 1-3 months. The duration for patients with acne and alopecia will be 1 day. Study Population Adult patients (≥ 18 years) with skin pathologies treated at the Dermatology Unit of IDEI.

Conditions

Acne; Acne Vulgaris; Alopecia, Androgenetic; Pigmented Lesions; Pigmented Skin Lesion

Keywords

Acne; Androgenetic alopecia; Pigmented lesions; Artificial Intelligence; Algorithms; Classification; Detection

Outcome Measures

Primary Outcomes (2)

• Concordance between the physician's diagnosis and that of the tool.

  Analysis of concordance between the diagnosis issued by the dermatologist and that determined by the Legit.Health tool.

  At the moment of enrollment up to 1 year

• Agreement of detected malignancy between the dermatologist and Legit.Health tool

  Correlation analysis of the suspected malignancy between the dermatologist and the Artificial Intelligence tool

  At the moment of enrollment up to 1 year

Secondary Outcomes (2)

• Acne severity

  At the moment of enrollment up to 1 year

• Severity of alopecia

  At the moment of enrollment up to 1 year

Study Arms (3)

Patients with pigmented lesions and suspected malignancy

Patients treated at IDEI hospitals and with pigments skin lesions, which are suspected malignancy. The practitioners will take a photo of the lesion and upload into the tool so as to confirm both the diagnosis and suspicion of malignancy

Patients diagnosed with acne

Patients treated at IDEI hospitals and diagnosed with acne. Practitioners will take a photo of patients' face and upload it into the tool so as to check the severity of acne and compare it with the gold standard

Patients diagnosed with femenine androgenetic alopecia

Patients treated at IDEI hospitals and diagnosed with femenine androgenetic alopecia. Practitioners will take a photo of the top of the head and upload it into the tool so as to check the severity of alopecia and compare it with the gold standard

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pigmented lesions and suspected malignancy, patients diagnosed with inflammatory acne and women with androgenetic alopecia. All these people will be treated at the dermatology service of IDEI hospitals

You may qualify if:

• Patients aged 18 years or older (16 years for acne).
• Patients with pigmented lesions meeting any of the following conditions:
• Presenting for the first time with a pigmented lesion.
• Previously scheduled for dermoscopy consultation for the first time or for review of pigmented lesions.
• Patients with active inflammatory acne.
• Women with androgenetic alopecia.

You may not qualify if:

• Patients deemed by the investigator to be unable or unwilling to comply with the study procedures.

Sponsors & Collaborators

• AI Labs Group S.L: lead
• Instituto de Dermatología Integral (IDEI): collaborator

Study Sites (1)

IDEI Hospital

Madrid, 28009, Spain

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Alopecia

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Sánchez-Viera, PhD

  IDEI Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Sánchez-Viera, PhD

CONTACT

sanchez.viera@ideidermatologia.com

Jordi Barrachina, PhD

CONTACT

+34 660675578; jordibarrachina@legit.health

Study Design

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

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: January 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

ES (1)