Non-Invasive Prospective Pilot in a Live Environment for the improvement of the diagnosis of Generalised Pustular Psoriasis

Study identification

• EU PAS number:
  EUPAS1000000910
• Study ID:
  1000000910
• Official title and acronym:
  Non-Invasive Prospective Pilot in a Live Environment for the improvement of the diagnosis of Generalised Pustular Psoriasis
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Title: Non-Invasive Prospective Pilot in a Live Environment for the improvement of the diagnosis of Generalised Pustular Psoriasis; Protocol Code: LEGIT HEALTH_BI_2024; Sponsor: Boehringer Ingelheim; ; Study Design & Objectives; This prospective, observational, cross-sectional study evaluated whether the AI-based medical device, Legit.Health Plus (v1.1.0.0), improves diagnostic accuracy for Generalized Pustular Psoriasis (GPP) and Hidradenitis Suppurativa (HS). The primary objective was to validate increased accuracy in HCPs diagnosing GPP, a rare condition often misdiagnosed in primary care.; ; Methods; Fifteen healthcare professionals (11 primary care physicians, 4 dermatologists) were recruited. Each participant evaluated 100 validated images of skin conditions, including GPP, HS, and confounders like eczema and acne. A pre-post design was used: participants diagnosed cases first without assistance, then reviewed the AI’s analysis (top 5 potential diagnoses with confidence levels) to confirm or revise their decision.; ; Key Results; Overall diagnostic accuracy significantly increased from 47.91% to 62.81% with the device (p < 0.05).; ; - Primary Care: Accuracy improved markedly from 44.29% to 61.71% (+17.4%).; - GPP (Primary Target): Overall accuracy doubled from 23.70% to 46.67% (p = 0.00001). In primary care, GPP detection rose by 120%.; - Hidradenitis Suppurativa: Accuracy improved from 85.48% to 93.60%.; - Palmoplantar Pustulosis: Primary care diagnoses increased by 146%.; ; Conclusion; The device significantly enhanced diagnostic accuracy for rare dermatological conditions, particularly in primary care settings where improvements reached 40%. No adverse events were reported.; ; Dates: 01/06/2024 – 15/09/2024
• Study status:
  Finalised

Research institutions and networks

Institutions

AI Labs Group S.L. (Legit.Health)

Spain

Study timelines

Date when funding contract was signed

Planned:27/05/2024

Actual:27/05/2024

Study start date

Planned:01/06/2024

Actual:01/06/2024

Date of final study report

Planned:15/09/2024

Actual:15/09/2024

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable