Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna

NCT01088737 | Unknown Phase 2

• 1 other identifier: Trial Photoderm Graz 2010-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lentigo Maligna

Keywords

Lentigo maligna; melanoma; imiquimod; prevention

Outcome Measures

Primary Outcomes (1)

• Elimination of possible subclinical lesions of LM that resides after surgical excision by determining the long-term recurrence rates.

  60 months

Secondary Outcomes (1)

• Incidence of subclinical residual lesions and local skin reactions.

  20 weeks

Interventions

Imiquimod DRUG

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.

Also known as: Aldara

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Having undergone surgical excision of LM or LMM
• Positive histological finding of LM or LMM (positive histology of primary excision)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Medical University of Graz, Dept. Dermatology

Graz, 8036, Austria

Location

Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Hutchinson's Melanotic Freckle; Melanoma

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Peter Wolf, MD

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Bioimmunotherapy

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

AU (2)