Clinical Trial: Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Open Monocentric Pilot Study to Investigate the Potential of Imiquimod 5% Cream to Detect Residual and to Prevent Recurrence of Lentigo Maligna After Surgical Excision

Brief 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

Detailed Summary: Imiquimod (Aldara) 5% cream will be applied starting 6 weeks post-surgery to an area within 5 cm of treatment margins to each side of the original scar of the LM or LMM excision. Time period between removal of stitches and first administration of imiquimod should be 4 weeks, correspondent to approximate 6 weeks post surgery. Imiquimod cream is applied once daily. Each patient will begin with the application 3x/week. After two weeks of treatment the inflammation response to imiquimod will be assessed. If no or only minor inflammation is detectable in the treatment area, the dosing schedule will be increased to 5x/week. After four weeks of treatment the inflammation response will be assessed again. If still no or only minor inflammation is detectable, application will be extended to daily use. An interruption of the treatment with imiquimod cream is considered if severe local inflammatory reaction occurs, severe systemic reactions are apparent or if super-infection is observed at the treatment area. The primary objective of the study is to investigate the potential of imiquimod 5% cream to eliminate possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates. Secondary objectives of the study describe the incidence of subclinical residual lesions and local skin reactions.
Sponsor: Medical University of Graz

Current Primary Outcome: Elimination of possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates. [ Time Frame: 60 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of subclinical residual lesions and local skin reactions. [ Time Frame: 20 weeks ]

Original Secondary Outcome: Same as current

Information By: Medical University of Graz

Dates:
Date Received: March 16, 2010
Date Started: January 2011
Date Completion: January 2020
Last Updated: December 23, 2016
Last Verified: December 2016