LIMIT I is a multicentre, open label, non randomised, single stage trial to test the effectiveness of topical imiquimod cream on lentigo maligna.
Details of the Disease
Lentigo Maligna (LM) is an early form of cancer which usually appears as a dark patch of skin on the face and neck. LM can grow very slowly over several years, and at this stage is harmless because the cancer is in the outer layer of the skin. However, there is a small possibility that it could grow deeper in the skin which increases the risk of the cancer spreading. Because of this risk, it is important that LM is treated effectively at an early stage. The current treatment is surgery to remove all the cancerous cells.
The Research
The purpose the this study is to see whether a drug, called imiquimod, is an effective alternative therapy to surgery. Patients will undergo 12 weeks of treatment with topical imiquimod. All patients will progress to re-mapping, biopsy and complete surgical excision. The primary objective is to find out the pathological complete regression rate when topically treating lentigo maligna lesions with imiquimod. The secondary objectives are to define the accuracy of clinical assessment of response after imiquimod; assess the tolerability of imiquimod; assess the cost-effectiveness of the treatments; determine whether imiquimod therapy might vaccinate against melanoma; and establish patient treatment preferences for future trial design.
Outcome Measures
The primary outcome measure is to establish the histological complete response rate of imiquimod for treating lentigo maligna.
Recruitment
The aim is to recruit 40 patients over an eight month period from April 2010
Funding
This study is funded by the NIHR Research for Patient Benefit Programme.
If you would like further details about this study, or would like to help with recruitment, please contact Trial Manager: Nazia Boota tel. 0115 8230579.
