Clinical trial · Interventional
Effect of Topical Imiquimod on Lentigo Maligna
NCT01161888CI-TRIAL-00007221LIMIT-1completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if topical imiquimod is effective in the pathological complete regression of lentigo maligna.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lentigo Maligna | Lentigo Maligna | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 (5)
- measure
- Clinical assessment of response after imiquimod treatment
- timeFrame
- Assessed at 12 week treatment visit and 1-2 week post surgery follow up
- description
- 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.
- measure
- Clinical feasibility of imiquimod treatment
- timeFrame
- Tolerability will be assessed during treatment period of 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.