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Effect of Topical Imiquimod on Lentigo Maligna

Phase 4
45 Years
Not Enrolling
Lentigo Maligna

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Trial Information

Effect of Topical Imiquimod on Lentigo Maligna

Inclusion Criteria:

- 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
entire circumference.

- Patient fit enough and willing to undergo surgery as required by the protocol.

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.

Outcome Time Frame:

Results available at 1-2 week post surgery follow up visit.

Safety Issue:


Principal Investigator

Jerry Marsden, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Birmingham NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2010

Completion Date:

March 2012

Related Keywords:

  • Lentigo Maligna
  • Lentigo
  • Hutchinson's Melanotic Freckle