Effect of Topical Imiquimod on Lentigo Maligna

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jerry Marsden
• Collaborator: Department of Health, United Kingdom
• Treatments: Imiquimod

Criteria

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 Team.

• 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.