Effect of Topical Imiquimod on Lentigo Maligna

NCT ID: NCT01161888

Last Updated: 2012-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

Brief Summary

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

Conditions

Lentigo Maligna

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Imiquimod

250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.

Intervention Type: DRUG

Other Intervention Names

Aldara 5% cream

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Health, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Jerry Marsden

OTHER

Sponsor Role: lead

Responsible Party

Jerry Marsden

Consultant Dermatologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jerry Marsden, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Locations

Dr J Marsden

Queen Elizabeth Hospital, Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

LIMIT-1

Identifier Type: -

Identifier Source: org_study_id