Multicenter Cluster-Randomized Controlled Trial Across Europe and Australia

Background & Aim

The study's primary objective is to assess the clinical impact and health-economic outcomes of using Dermalyser as a diagnostic decision support tool in primary care.

By comparing standard care with versus without Dermalyser, the trial evaluates whether Dermalyser improves referral accuracy, reduces unnecessary excisions, and maintains or improves early detection of melanoma and keratinocyte cancers (BCC and SCC).

Study Details

1. Design: Multicenter, cluster-randomized controlled trial with cross-over
2. Sites: Sweden, Germany, Netherlands, Scotland, Australia
3. Sample size: ~3,000 patients
4. Eligibility: Adults ≥18 years presenting in primary care with suspicious pigmented or non-pigmented skin lesions where malignancy cannot be excluded
5. Control group: Standard primary care without Dermalyser
6. Intervention group: Standard primary care with Dermalyser

Summary of Results

Results are pending. The primary endpoints include:

1. Proportion of patients excised or referred
2. Proportion of malignant cases among those excised/referred
3. Missed cancers identified during up to 5 years of follow-up

This is, to our knowledge, the first randomized multicenter RCT worldwide in primary care evaluating AI-based image analysis for skin cancer diagnostics.