E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aktiniske keratoser og nodulære basalcellecarcinomer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000614 |
E.1.2 | Term | Actinic keratosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004146 |
E.1.2 | Term | Basal cell carcinoma |
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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 |
Reduktion i antallet af behandlede aktiniske keratoser og basalcelle carcinomer, samt antal recidiverende elementer |
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E.2.2 | Secondary objectives of the trial |
Bivirkninger, Smerte, kosmetisk resultat samt flourescens |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patienter over 18 år Informeret mundtligt samt skriftligt samtykke Hudtype I-III Patienter med moderate til svære aktiniske keratoser(AK) (grad 2: moderat tykke AK som tydeligt ses og føles; grad 3: meget tykke og/ eller tydelige AK) i symmetriske områder svarende til skalpen, ansigt eller på hænder. Omkring AK indtegnes to symmetriske felter på hver mindst 5 x 5 cm. Hver felt skal indeholde 2–10 elementer. Patienter til behandling af histologiverificerede nodulære basalcelle carcinomer (BCC). Kun patienter med elementer i ansigtet der vurderes vanskelige at behandle og dårligt egnede til kirurgi inkluderes ud fra følgende kriterier: i) Elementer i H-zonen10 (på nasi, philtrum, labia oris, nedre periorbitale område, tindinger, peri-aurikulære område inklusiv auricula), ii) elementer over 15 mm i diamenter samt iii) elementer på svær solskadet hud. Fertile kvinder skal anvende sikker antikonception (p-piller, spiral, gestagendepotinjektion eller subdermal implantation, hormonel vaginal ring, transdermal depotplaster eller sterilisation) i forsøgsperioden.
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E.4 | Principal exclusion criteria |
§ Gravide og ammende § Patienter med kendt overfølsomhed for de aktive stoffer eller hjælpestofferne i Metvix. § Kendt tendens til at danne hypertrofiske ar eller keloider. Patienter som ikke skønnes at ville kunne følge behandlingsprotokollen (ex. demente, psykisk syge, alkoholiserede m.v.). Patienter der ikke giver informeret samtykke. Patienter med AK der på inklusionstidspunkter har spinocellulært carcinom i forsøgsområdet. Pigmenterede BCC. Morphea BCC. Patienter med Gorlins syndrom eller pophyri. Patienter med kendt herpes simplex virus infektion i det behandlingskrævende hudområde.
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduktion i antal behandlede aktiniske keratoser og nodulære basalcelle carcinomer Antal recidiverende elementer Lokale bivirkninger Kosmetiske resultat Smerte PpIX fluorescens |
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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 | Yes |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 | No |
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 |
laser treatment before metvix, creme applikation |
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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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47 patienter der inkluderes og behandles efter protokollen |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |