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
Conditions
Interventions
Trade Name: Aldara 5 % Cream
Pharmaceutical Form: Cream
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to investigate the potential of Imiquimod 5% cream to eliminate possible subclinical lesions of lentigo maligna (LM) that resides after surgical excision by determining the long-term recurrence rates. ;Secondary Objective: Secondary objectives of the study describe the incidence of subclinical residual lesions and local skin reactions;Primary end point(s): No residual lesion and no inflammatory response detected between Day 1 and Week 12, no lesion visible at Week 20. No residual lesion and no inflammatory response detected between Day 1 and Week 12, at least one lesion is visible at Week 20. No residual lesion, but inflammatory response detected between Day 1 and Week 12, no lesion visible at Week 20. No residual lesion, but inflammatory response detected between Day 1 and Week 12, at least one lesion is visible at Week 20. Residual lesions detected between Day 1 and Week 12, no lesion visible at Week 20. F) Residual lesions detected between Day 1 and Week 12, at least one lesion is visible at Week 20. | — |
Countries
Austria
Outcome results
None listed