Effect of Topical Imiquimod on Lentigo Maligna

NCT01161888 | Completed Phase 4 DMC

• 1 other identifier: LIMIT-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Results available at 1-2 week post surgery follow up visit.

Secondary Outcomes (5)

• Clinical assessment of response after imiquimod treatment

  Assessed at 12 week treatment visit and 1-2 week post surgery follow up

• Clinical feasibility of imiquimod treatment

  Tolerability will be assessed during treatment period of 12 weeks

• Number of consultations with NHS staff during imiquimod treatment

  Assessed up to week 12 visit

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

  Assessed with baseline and 12 week visit samples.

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

  Questionnaire completed at 12 weeks post surgery (follow up visit)

Interventions

Imiquimod DRUG

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

Also known as: Aldara 5% cream

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jerry Marsden: lead
• Department of Health, United Kingdom: collaborator

Study Sites (1)

Dr J Marsden

Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jerry Marsden, Dr

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Dermatologist

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: July 14, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2010-05

Locations

GB (1)