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 excisio

• Conditions: 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

• Registration Number: EUCTR2010-019422-13-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To be eligible, a patient must comply with all of the following criteria:
1.Having undergone surgical excision of LM or LMM.
2.Positive histological finding of LM or LMM (positive histology of primary
excision).
3.Age = 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient is ineligible and must not enter the study if any of the following criteria is met:
Safety concerns:
1.History of allergic reaction to imiquimod or its excipients.
2.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.
Lack of suitability for the study:
3.History of malignant melanoma having metastasised or where metastasis could be expected.
4.Other malignant tumours in the study treatment area (exception actinic keratosis (AK)).
Administrative reasons:
5.Lack of ability or willingness to give informed consent.
6.Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
7.Anticipated non-availability for study visits/procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified