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Effect of Topical Imiquimod on Lentigo Maligna

Information source: University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lentigo Maligna

Intervention: Imiquimod (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Jerry Marsden

Official(s) and/or principal investigator(s):
Jerry Marsden, Dr, Principal Investigator, Affiliation: University Hospitals Birmingham NHS Foundation Trust

Summary

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

Clinical Details

Official title: Effect of Topical Imiquimod on Lentigo Maligna

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

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

Secondary outcome:

Clinical assessment of response after imiquimod treatment

Clinical feasibility of imiquimod treatment

Number of consultations with NHS staff during imiquimod treatment

Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.

Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dr J Marsden, Queen Elizabeth Hospital, Birmingham B15 2TH, United Kingdom
Additional Information

Starting date: June 2010
Last updated: June 18, 2012

Page last updated: August 23, 2015

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