Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna

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

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

Study Overview

• Status: Unknown
• Conditions: Lentigo Maligna
• Intervention / Treatment: Drug: Imiquimod

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz
  • Graz, Austria, 8036
    • Medical University of Graz, Dept. Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of subclinical residual lesions and local skin reactions.	20 weeks

Collaborators and Investigators

• Sponsor: Medical University of Graz

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimate): March 17, 2010

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: prevention; imiquimod; melanoma; Lentigo maligna
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Hyperpigmentation; Pigmentation Disorders; Melanosis; Melanoma; Recurrence; Lentigo; Hutchinson's Melanotic Freckle; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Imiquimod
• Other Study ID Numbers: Trial Photoderm Graz 2010-1