Dermalyser is being evaluated in a prospective, double-blinded clinical study at Sahlgrenska University Hospital

Background & Aim

The study's primary objective is to evaluate the diagnostic accuracy of Dermalyser in differentiating invasive melanoma from melanoma in situ, as well as distinguishing thin (≤1.0 mm) from thick (>1.0 mm) invasive melanomas. This distinction is critical for treatment planning and prognosis.

The study also aims to compare Dermalyser's performance directly with board-certified dermatologists, using histopathology (PAD) as the reference standard.

Study Details

• Design: Single-center, prospective, double-blinded clinical trial
• Site: Sahlgrenska University Hospital, Gothenburg, Sweden
• Sample size: Up to ~900 patients screened, with ~300 histopathologically verified melanomas included
• Eligibility: Adults scheduled for excision of a suspected primary melanoma lesion

Summary of Results

Results are pending. The study will generate key evidence on Dermalyser's ability to accurately discriminate invasive from in situ melanoma, and thin from thick invasive melanomas. The outcomes will be critical for regulatory submissions and for validating clinical utility in secondary care dermatology.