Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna - Full Text View

Purpose

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

Condition	Intervention	Phase
Lentigo Maligna	Drug: Imiquimod	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Imiquimod

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:

Elimination of possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates. [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of subclinical residual lesions and local skin reactions. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	January 2011
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Intervention Details:

Imiquimod 5% 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.

Other Name: Aldara

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088737

Contacts

Contact: Peter Wolf, MD	+43 316 385 ext 80315	peter.wolf@medunigraz.at
Contact: Ingrid Wolf, MD+	+43 316 385 ext 13254	ingrid.wolf@medunigraz.at

Locations

Austria
Medical University of Graz	Not yet recruiting
Graz, Austria, 8036
Contact: Ingrid Wolf, MD +43 316 385 ext 13254 ingrid.wolf@medunigraz.at
Contact: Peter Wolf, MD+ +43 316 385 ext 12371 peter.wolf@medunigraz.at
Sub-Investigator: Ingrid Wolf, MD
Sub-Investigator: Verena Ahlgriem-Siess, MD
Sub-Investigator: Regina Fink-Puches, MD
Sub-Investigator: Rainer Hofmann-Wellenhof, MD
Sub-Investigator: Erika Richtig, MD
Sub-Investigator: Helmut Schaider, MD
Sub-Investigator: Alexandra Gruber-Wackernagel, MD
Principal Investigator: Peter Wolf, MD
Medical University of Graz, Dept. Dermatology	Recruiting
Graz, Austria, 8036
Contact: Peter Wolf, MD +43 316 385 ext 13254 peter.wolf@medunigraz.at
Contact: Ingrid Wolf, MD +43 316 385 ext 13254 ingrid.wolf@medunigraz.at

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator:

Peter Wolf, MD

Medical University of Graz, Austria

More Information

No publications provided

Responsible Party:	Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier:	NCT01088737 History of Changes
Other Study ID Numbers:	Trial Photoderm Graz 2010-1
Study First Received:	March 16, 2010
Last Updated:	February 12, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:

Lentigo maligna
melanoma
imiquimod
prevention

Additional relevant MeSH terms:

Pigmentation Disorders
Lentigo
Recurrence
Hutchinson's Melanotic Freckle
Melanosis
Hyperpigmentation
Skin Diseases
Disease Attributes
Pathologic Processes
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 16, 2013