Effect of Topical Imiquimod on Lentigo Maligna

Lentigo Maligna Clinical Trial

— LIMIT-1  

Official title:

Effect of Topical Imiquimod on Lentigo Maligna

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161888
• Other study ID #: LIMIT-1
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: June 18, 2012
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2010
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lentigo
• Lentigo Maligna

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Dr J Marsden	Queen Elizabeth Hospital, Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Jerry Marsden	Department of Health, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Clinical assessment of response after imiquimod treatment	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.	Assessed at 12 week treatment visit and 1-2 week post surgery follow up	No
Secondary	Clinical feasibility of imiquimod treatment	Number of reported local adverse reactions and systemic adverse reactions; adherence to treatment schedule and acceptability of imiquimod treatment.	Tolerability will be assessed during treatment period of 12 weeks	Yes
Secondary	Number of consultations with NHS staff during imiquimod treatment		Assessed up to week 12 visit	No
Secondary	Frequency of functional T cell responses recognising peptide epitopes in melanocyte differentiation and cancer-testis antigens.	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.	Assessed with baseline and 12 week visit samples.	No
Secondary	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)	No