Optimization of Clinical Workflow in Patients with Various Dermatological Conditions through Artificial Intelligence (Legit.Health_IDEI_2023)

Study type

• Study topic:
  Disease /health condition

  Medical device
• Study topic, other:
  Diagnosis of different skin pathologies
• Study type:
  Non-interventional study
• Scope of the study:
  Method development or testing

  Validation of study variables (exposure outcome covariate)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Acne

  Androgenetic alopecia

  Skin lesion
• Additional medical condition(s):
  Pigmented lesions suspected of malignancy

Population studied

• Short description of the study population:
  - Patients with pigmented lesions and suspected malignancy; - Patients 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
• Age groups:
  Adult and elderly population (>18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  150

Study design details

• Study design:
  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 time for retrospective analysis
• Main study objective:
  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.
• Setting:
  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.
• Outcomes:
  Primary Outcome Measure: 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.; Time Frame: At the moment of enrollment up to 1 year.; ; Primary Outcome Measure: 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.; Time Frame: At the moment of enrollment up to 1 year.; ; Secondary Outcome Measure: Acne severity.; Severity of acne assessed by both physicians and Legit.Health tool through lesion counting. A correlation analysis will be performed to check differences of criteria between them.; Time Frame: At the moment of enrollment up to 1 year.; ; Secondary Outcome Measure: Severity of alopecia.; Severity of androgenetic alopecia assessed by both physicians and Legit.Health tool with the Ludwig scale. A correlation analysis will be performed to check differences of criteria between them.; Time Frame: At the moment of enrollment up to 1 year.;