E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives of the study describe the incidence of subclinical residual lesions and local skin reactions |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pilot study to investigate the potential of imiquimod 5% cream |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Duration of individual treatment 12 weeks with a 5-year observational follow-up period
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |