Résumé
Background Lentigo maligna (LM) is a melanocytic proliferation occurring on photo‐exposed skin that may progress to LM melanoma. Surgery is recommended as first‐line treatment. Excision margins of 5–10 mm remain, without international consensus. Several studies have shown that imiquimod, an immunomodulator, induces LM regression. This study investigated the effect of imiquimod versus placebo in neoadjuvant settings. Patients and Methods We performed a prospective, randomized, multicentre, phase III clinical study. Patients were randomly assigned in 1:1 ratio to receive imiquimod or placebo for 4 weeks, followed by LM excision 4 weeks after the last application of imiquimod or placebo. The primary endpoint was extra‐lesional excision, with a 5 mm margin from the residual pigmentation after imiquimod or vehicle. Secondary endpoints included the gain on the surface removed between the two groups; number of revision surgeries to obtain extra‐lesional excisions; relapse‐free time; and number of complete remissions after treatment. Results A total of 283 patients participated in this study; 247 patients, 121 patients in the placebo group and 126 in the imiquimod group, accounted for the modified ITT population. The first extralesional extirpation was performed in 116 (92%) imiquimod patients and in 102 (84%) placebo patients; the difference was not significant ( p = 0.0743). Regarding the surface of LM, imiquimod reduced the LM surface (4.6–3.1 cm 2 ) significantly ( p < 0.001) more compared to the placebo (3.9–4.1 cm 2 ). Conclusion Imiquimod reduces the lentigo maligna surface after 1 month of treatment, without a higher risk of intralesional excision and with a positive aesthetic outcome.