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
18 Years
N/A
Both
Lentigo Maligna
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Elimination of possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates.
Outcome Time Frame:
60 months
Safety Issue:
No
Principal Investigator
Peter Wolf, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical University of Graz, Austria
Authority:
Austria: Federal Office for Safety in Health Care
Study ID:
Trial Photoderm Graz 2010-1
NCT ID:
NCT01088737
Start Date:
January 2011
Completion Date:
January 2017
Related Keywords:
- Lentigo Maligna
- Lentigo maligna
- melanoma
- imiquimod
- prevention
- Lentigo
- Recurrence
- Hutchinson's Melanotic Freckle
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