Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face
The primary endpoint of the study is to demonstrate that neoadjuvant treatment of LM by
imiquimod prior to surgery can reduce the frequency of intralesional excisions as from the
first surgical procedure, with a healthy tissue margin of 5mm. Furthermore, the improvement
in patient quality of life could also be significant.
The number of patients to be included in the study is 268.
For each patient, the study will involve several stages (S), as follows:
S0 (Selection): information and obtaining of the patient's informed consent. Performance of
biopsy for histological confirmation of LM
S1 (S0 + ~ 2 weeks): patient inclusion following anatomopathological confirmation of LM.
Patient randomisation in one or other study arm: imiquimod versus placebo and initiation of
S2 (S1 + 4 weeks): Discontinuation of imiquimod/placebo application. Scheduling of the
surgical procedure 4 weeks later.
S3 (S2 + 4 weeks): Surgery.
S4: After the last surgical procedure, simple clinical follow up will be ensured every 6
months for a period of 3 years, in order to study the recurrence rate.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the margin of resection. Success is defined by an extralesional excision as from the first surgical procedure performed with a healthy tissue margin of 5 mm.
Brigitte Dréno, MD, PhD
Nantes University Hospital
France: ANSM - Agence nationale de sécurité du médicament et des produits de santé