Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna
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| First Received Date ICMJE | March 16, 2010 | ||||||||
| Last Updated Date | February 12, 2013 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01088737 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Incidence of subclinical residual lesions and local skin reactions. [ Time Frame: 20 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Imiquimod to Detect Residual Lesions and Prevent Recurrence of Lentigo Maligna | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Lentigo Maligna | ||||||||
| Intervention ICMJE | Drug: Imiquimod
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 |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Estimated Completion Date | January 2017 | ||||||||
| Estimated Primary Completion Date | January 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01088737 | ||||||||
| Other Study ID Numbers ICMJE | Trial Photoderm Graz 2010-1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Peter Wolf, MD, Medical University of Graz | ||||||||
| Study Sponsor ICMJE | Medical University of Graz | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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