Addition of dermoscopy to conventional naked-eye examination in melanoma screening: a randomized study.

OBJECTIVE We sought to assess the difference in lesion management between combined examination (naked-eye and dermoscopy) and conventional naked-eye examination in evaluations for melanoma; and to assess the impact on patient treatment of facilities for digital follow-up of diagnostically equivocal lesions. METHODS We conducted a randomized, controlled trial at a pigmented lesion clinic in a university hospital. A total of 938 consecutive subjects presenting between November 1, 2001, and March 31, 2002, were eligible and 25 were excluded because they were younger than 12 years of age; hence 913 subjects were enrolled. Participants were randomized to combined examination with mandatory excision of equivocal lesion (arm B) and with possibility of digital follow-up according to the clinician's decision (arm C), or to conventional naked-eye examination (mandatory excision of equivocal lesion) (arm A). The same pigmented lesion clinic staff examined all subjects. RESULTS Combined examination determined a significant reduction in the percentage of patients referred for operation (9.0% vs 15.6%) (P =.013). When facilities for digital follow-up of equivocal lesions were available, the percentage of patients classified as harboring lesions difficult to diagnose increased (group C, 35.8%; group B, 17.8%; P <.01). About half of them were immediately referred for operation whereas the remainder submitted to second examination (digital follow-up). Two melanomas (1 in situ and 1 invasive, 0.40-mm thick) were diagnosed after second examination performed 6 months later. The number of melanomas eventually excised within the study were similar among the 3 allocation groups (3, 2, and 3, respectively). CONCLUSIONS the addition of dermoscopy to conventional naked-eye examination is associated with a significant reduction of number of pigmented skin lesions excised for diagnostic verification. The possibility of digital follow-up of equivocal lesions is associated with a not negligible occurrence of initial melanomas left unexcised until the second consultation.