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Effect of Topical Imiquimod on Lentigo Maligna (LIMIT-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01161888
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : June 20, 2012
Department of Health, United Kingdom
Information provided by (Responsible Party):
Jerry Marsden, University Hospital Birmingham NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Lentigo Maligna Drug: Imiquimod Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Topical Imiquimod on Lentigo Maligna
Study Start Date : June 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Intervention Details:
  • Drug: 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.
    Other Name: Aldara 5% cream

Primary Outcome Measures :
  1. Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices. [ Time Frame: Results available at 1-2 week post surgery follow up visit. ]

Secondary Outcome Measures :
  1. Clinical assessment of response after imiquimod treatment [ Time Frame: Assessed at 12 week treatment visit and 1-2 week post surgery follow up ]
    The pathological response in the entire resected lesion will be compared with that predicted from clinical examination and biopsies taken before surgery, post imiquimod treatment. We will assess whether adequate surgical margins can be determined using clinical maps. It is essential to know the accuracy of the method of clinical assessment of response.

  2. Clinical feasibility of imiquimod treatment [ Time Frame: Tolerability will be assessed during treatment period of 12 weeks ]
    Number of reported local adverse reactions and systemic adverse reactions; adherence to treatment schedule and acceptability of imiquimod treatment.

  3. Number of consultations with NHS staff during imiquimod treatment [ Time Frame: Assessed up to week 12 visit ]
  4. Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens. [ Time Frame: Assessed with baseline and 12 week visit samples. ]
    Circulating immune responses to proteins expressed within melanoma will be measured using blood draws taken before imiquimod treatment and after completion of imiquimod therapy but before surgery. The demonstration of a circulating immune response would be an important finding that would strongly support the investigation of imiquimod as primary therapy for melanoma, even if coupled with subsequent surgery because of the potential for such an immune response to be preventative against recurrence or invasive disease.

  5. Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique. [ Time Frame: Questionnaire completed at 12 weeks post surgery (follow up visit) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01161888

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United Kingdom
Dr J Marsden
Queen Elizabeth Hospital, Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Jerry Marsden
Department of Health, United Kingdom
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Principal Investigator: Jerry Marsden, Dr University Hospitals Birmingham NHS Foundation Trust

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Responsible Party: Jerry Marsden, Consultant Dermatologist, University Hospital Birmingham NHS Foundation Trust Identifier: NCT01161888     History of Changes
Other Study ID Numbers: LIMIT-1
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: May 2010

Additional relevant MeSH terms:
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Hutchinson's Melanotic Freckle
Pigmentation Disorders
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers