Lead investigator:

Jerry Marsden, Birmingham.

Interventions: 

This is an open label, non-randomised phase II study.  Patients will undergo 12 weeks of treatment with topical imiquimod.  They will be seen at 2, 4 and 8 weeks for possible dose adjustment.  All patients will progress to re-mapping, biopsy and complete surgical excision.  The entire specimen will be sectioned and examined histologically, and pathological complete, partial or no response will be determined.

Outcomes:

Primary outcome measure is to establish the histological complete response rate of imiquimod for treating lentigo maligna.

Justification for the trial:

Topical treatment for lentigo maligna would avoid many of the limitations of surgery and radiotherapy.  This study could provide valuable information about the effectiveness of imiquimod.

Initial discussions and prioritisation of trial ideas with leading clinicians in EB have led to this study being identified as the most achievable and relevant at the current time.