Effect of topical imiquimod on lentigo maligna. - Effect of topical imiquimod on lentigo maligna

Phase 1

Active, not recruiting

• Conditions: lentigo maligna; MedDRA version: 12 Level: LLT Classification code 10024218 Term: lentigo maligna

• Registration Number: EUCTR2009-016909-42-GB
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified