E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
To compare the efficacy of topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream in the treatment of actinic keratoses in organ transplant recipients |
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E.2.2 | Secondary objectives of the trial |
To compare the tolerability, the patients' satisfaction and the duration of the disease-free interval after treatment with topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream of actinic keratoses in organ transplant recipients To compare the reduction in the field cancerisation after treatment with topical imiquimod 5% cream versus photodynamic therapy with methyl-aminolaevulinate 16% cream of actinic keratoses in organ transplant recipients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 years or older Patients who had received a kidney, liver, lung or heart transplant more than 3 years prior to inclusion into the study Patients who had been treated at least 6 month prior to study entry with a stable twofold or threefold immunsupressive treatment Patients who had clinically confirmed epithelial dysplasia (actinic keratoses) in at least two anatomically separated contralateral areas on the face and/or scalp with comparable size and extension and minimum distance of 5 cm |
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E.4 | Principal exclusion criteria |
Invasive squamous cell carcinoma or basal cell carcinoma in the treatment area Known allergy to imiquimod and aminolaevulinic acid Patients who have received retinoids, interferons or investigational drugs within 4 weeks of study initiation Patients who are participating in other dermatological study Patients with instable organ function Persistent Hepatitis B or C infections Any evidence of systemic cancer Patients who have received any systemic cancer chemotherapy or radiation therapy Pregnant and lactating women
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical complete remission rate of actinic keratoses in organ transplant recipients 4 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminoöaevulinate 16% cream |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 weeks after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream |
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E.5.2 | Secondary end point(s) |
Clinical complete remission rate of actinic keratoses in organ transplant recipients 6 and 12 months after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream Global reduction of the area of specific fluorescence 1, 6 and 12 months after completion of treatment with imiquimod 5% cream and photodynamic therapy with methyl-aminolaevulinate 16% cream Treatment-associated Pain during the treatment and 2 and 4 weeks after completion of treatment Cosmetic response 1, 3, 6 and 12 months after completion of treatment Global patients' satisfaction 1, 3, 6 and 12 months after completion of treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Clinical complete remission rate: 6 and 12 months after completion of treatment Global reduction of the area of specific fluorescence: 1, 6 and 12 months after completion of treatment Treatment-associated Pain: during the tratment, 2 and 4 weeks after completion of treatment Cosmetic response 1, 3, 6 and 12 months after completion of treatment Global patients' satisfaction 1, 3, 6 and 12 months after completion of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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End of the trial after completion of the follow-up examination 12 months post therapy of 30 participants |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
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 | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |