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] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
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 evaluate clinical efficacy of daylight photodynamic therapy using Metvixia®compared to conventional PDT treatment using Metvixia® |
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E.2.2 | Secondary objectives of the trial |
1 To assess the safety of treatment
2 To assess the clinical efficacy at 1 month and 6 months post treatment
3 To assess the appearance of new keratoses 1 month rate, 3 months and 6 months
4 To consider the possible relationship between treatment efficacy at 1 month, 3 months and 6 months depending on the amount of light received |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Clinical diagnosis of at least 10 previously untreated AK lesions of Grade 1 and/or 2 of the scalp (at least 5 KA at each hlf of the scalp)
•Males or females above 18 years of age.
•Written informed consent.
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E.4 | Principal exclusion criteria |
- Patients with porphyria.
-Known allergy to metvixia® compound or excipients of the cream.
-Patients with history of hypersensitivity to nut products
-Patients receiving local treatment in the scalp areaea within the last 30 days.
-Patients receiving topical treatment,chemotherapy or immunotherapy in scalp area within the last 2 months.
-Sclerodermiform / nodular basal cell/intraepithelial carcinoma in the treated area
-Pregnant or breast-feeding women
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of disapeared Actinic Keratosis at 3 month |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- To evaluate the safety of treatment (questionnaire and pain assessment)
- The disappearance rate at 1 month and 6 months (relative to the layer of the inclusion visit)
- The emergence of new keratoses at 1 month and 6 months (new KAappeared) rates.
- The relationship between dose of sunlight received, measured by the luxmeter worn by the patient at the time of exposure, and clinical
efficacy 1 month, 3 months and 6 months |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0, 1 month, 3 month ant 6 month |
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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 | 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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 |
Patient is its own comparator |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
the same product (METVIXIA) |
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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.8.5 | 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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |