Clinical trial NCT01161888: Effect of Topical Imiquimod on Lentigo Maligna
Official title: Effect of Topical Imiquimod on Lentigo Maligna
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lentigo Maligna
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Department of Health, United Kingdom
First posted: 2010-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Pathological complete regression (PCR) in the mapped biopsied and resected LM using 2 mm slices.
timeFrame: Results available at 1-2 week post surgery follow up visit.
Secondary outcomes:
measure: Clinical assessment of response after imiquimod treatment
timeFrame: Assessed at 12 week treatment visit and 1-2 week post surgery follow up
measure: Clinical feasibility of imiquimod treatment
timeFrame: Tolerability will be assessed during treatment period of 12 weeks
measure: Number of consultations with NHS staff during imiquimod treatment
timeFrame: Assessed up to week 12 visit
measure: Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.
timeFrame: Assessed with baseline and 12 week visit samples.
measure: Measurement of hypothetical treatment preferences for surgery or imiquimod for LM using standard gamble technique.
timeFrame: Questionnaire completed at 12 weeks post surgery (follow up visit)
Other outcomes:
Locations:
city: Queen Elizabeth Hospital, Birmingham
country: United Kingdom
facility: Dr J Marsden
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Jerry Marsden, Dr
role: PRINCIPAL_INVESTIGATOR
References: