- Clinical diagnosis of lentigo maligna (LM) (acquired pigmented macule present for
more than 12 months with no change in skin surface texture or contour, no
palpability, diameter >10 mm, sited on the head or neck). The lower anatomical limit
is the root of the neck - a line joining the medial end of the clavicles with the
medial insertion of trapezius.
- Histological findings consistent with LM (increased numbers of atypical melanocytes
confined to the epidermis, sun damaged skin) in one or more 4mm punch biopsies(s)
from the darkest area, reported by a pathologist with expertise in the diagnosis of
melanocytic lesions, and part of a recognised NHS skin cancer Multi-Disciplinary
- The upper limit of the lesion is not defined by size, but it must be suitable for
complete surgical excision using a 5 mm lateral margin.
- The outline of the lesion must be easily defined visually in daylight around its
- Patient fit enough and willing to undergo surgery as required by the protocol.
- Clinical or histological evidence of invasive melanoma including any palpability of
the lesion, or clinical and/or histological evidence of regression or dermal invasion
- Aged less than 45 years
- Recurrent LM - the index lesion must not have been previously treated
- Life expectancy of less than 12 months
- Other skin lesions which may compromise the ability to complete this study, such as
co-existing or adjacent melanoma or non-melanoma skin cancer. Co-existing adjacent
actinic keratoses would not exclude the patient from the study
- Women of childbearing potential, who are pregnant, plan to become pregnant during
their study participation or breastfeeding.
- Unable to give informed consent.
- Hypersensitivity to imiquimod or to any of the excipients (methylhydroxybenzoate
(E218), propylhydroxybenzoate (E216), cetyl alcohol and stearyl alcohol).
- Taking immunosuppressive medication.
- Taking part in any other intervention study.