lentigo maligna MedDRA version: 12 Level: LLT Classification code 10024218 Term: lentigo maligna
Conditions
Interventions
Trade Name: Aldara 5% Cream
Product Name: Imiquimod
Product Code: N/A
Pharmaceutical Form: Cream
INN or Proposed INN: imiquimod
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. • 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. • Unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out the pathological complete regression (CR) rate when topically treating lentigo maligna lesions with imiquimod. Pathological Complete Regression means that the lesion has completely been removed when the skin is looked at under a microscope (histopathology). ; Secondary Objective: - Find out if clinicians can accurately tell whether the lesion has completely gone after imiquimod treatment by examining the area and comparing this to the histopathology result. - Find out what side effects there are of imiquimod treatment and what patients think of the imiquimod treatment. - To find out how much it will cost the NHS to treat LM patients with imiquimod. - To find out of imiquimod treatment might potentially provide the patient with some immunity (vaccination) against melanoma (that may occur in the future). - To find out the patients treatmetn preference for the design of a future randomised controlled trial. ; Primary end point(s): Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2mm slices. | — |
Countries
United Kingdom
Outcome results
None listed