Status:
COMPLETED
Effect of Topical Imiquimod on Lentigo Maligna
Lead Sponsor:
Jerry Marsden
Collaborating Sponsors:
Department of Health, United Kingdom
Conditions:
Lentigo Maligna
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01161888
Start Date
June 1 2010
End Date
March 1 2012
Last Update
June 20 2012
Active Locations (1)
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1
Dr J Marsden
Queen Elizabeth Hospital, Birmingham, United Kingdom, B15 2TH