Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, longitudinal, uncontrolled study with follow-up for 5 years.Patients having undergone surgical excision of lentigo maligna (LM) or lentigo maligna melanoma (LMM) will be invited to this study. Eligible patients will start treatment with imiquimod 6 weeks after the excision, the treatment will last for up to 12 weeks. Inflammatory reactions and the occurrence of residual lesions will be documented. The healing effect will be determined (initial clearance rate) 20 weeks after start of treatment with imiquimod. All patients who were enrolled (=exposed to imiquimod in this study) will be followed up for 5 years or until recurrence of the LM or LMM

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Treatments: Imiquimod

Criteria

Inclusion Criteria:

• Age > 18 years

• Having undergone surgical excision of LM or LMM

• Positive histological finding of LM or LMM (positive histology of primary excision)

Exclusion Criteria:

• History of allergic reaction to imiquimod or its excipients.

• Pregnancy, breast-feeding or planned pregnancy during the study and women of child-bearing potential not using adequate contraception. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner

• History of malignant melanoma having metastasised or where metastasis could be expected

• Other malignant tumours in the study treatment area (exception actinic keratosis (AK))

• Lack of ability or willingness to give informed consent

• Lack of willingness to have personal study related data collected, archived or transmitted according to protocol

• Anticipated non-availability for study visits/procedures