E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Actinic keratoses. These are dysplasia of the epidermis caused by chronic UV-irradiation, that developwithout treatment in 20% of the cases into skin cancer (spinalioma).
aktinische Keratosen. Dies sind durch chronische UV-Strahlung entstandene Dysplasien der Oberhaut (Epidermis), die bei fehlender Behandlung in ca 20% der Fälle in Hautkrebs (Plattenepithel-Carcinom) übergehen können. |
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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 |
Regression of actinic keratoses due to topic treatment with Birken-Oleogel
Rückbildung der aktinischen Keratosen durch lokale Behandlung mit Birken-Oleogel |
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E.2.2 | Secondary objectives of the trial |
Comparison to standard therapy (treatment with liquid nitrogen); comparison to the combined treatment with liquid nitrogen and Birken-Oleogel. tolerance of treatment.
Vergleich zu einer Standardthrapie (Besprühen mit flüssigem Stickstoff); Vergleich zur kombinierten Behandlung mit flüssigem Stickstoff und Birken-Oleogel. Verträglichkeit |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
adult male and female patients with <10 clinical or histological confirmed actinic keratosis . erwachsene männliche und weibliche Patienten mit <10 klinisch oder histologisch diagnostizierten aktinischen Präkanzerosen
informed consent of patients
schriftliche Einwilligungserklärung des Patienten nach Aufklärung
Agreement of the patient to follow the instructions of the investigator i.e. to conform to the condition of the clinical trial
Bereitschaft des Patienten, den Anweisungen des Prüfarztes zu folgen, d.H. die Studienbedingungen einzuhalten. |
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E.4 | Principal exclusion criteria |
>10 lesions, pigmented lesions
>10 Läsionen, pigmentierte Läsionen
adjuvant/simultaneous UV-therapy
gleichzeitige UV-Therapie
simultaneous treatment with other therapeuticals for actinic kertoses
gleichzeitige Anwendung anderer für aktinische Keratosen zugelassener Therapieverfahren und Externa (außer der Vergleichstherapie) |
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E.5 End points |
E.5.1 | Primary end point(s) |
regression of actinic keratoses after 12 weeks treatment.
Rückbildung der aktinischen Keratosen nach 12 Wochen Behandlung. |
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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 | Information not present in EudraCT |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |