E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 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 |
Evaluere effekten af dagslys-medieret fotodynamisk terapi med methyl aminolevulinat ved behandling af basal celle karcinomer |
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E.2.2 | Secondary objectives of the trial |
Recidiv frekvens ved 6 og 12 måneders kontrol, smerte under behandlingen, bivirkninger umiddelbart efter behandling (rødme og sårdannelse), sene bivirkninger (hypo- og hyperpigmentering og ar), kosmetisk resultat |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patienter på 18 år eller derover. Informeret skriftligt og mundtligt samtykke. Patienter til behandling af histologiverificerede primære BCC i områder der nemt kan eksponeres for dagslys Fertile kvinder skal anvende sikker antikonception (p-piller, spiral, gestagendepotinjektion eller subdermal implantaion, hormonel vaginal ring, transdermal depotplaster eller sterilisation) i forsøgsperioden
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E.4 | Principal exclusion criteria |
Patienter som modtager immunsupprimerende medicinsk behandling eller af anden årsag er immunsupprimerede (fx HIV-positive patienter og diabetikere). Gravide eller ammende patienter. Patienter med kendt øget lysfølsomhed for synligt lys (ex. patienter med porphyri). Patienter som ikke skønnes at ville følge behandlingsprotokollen (fx svært alkoholiserede patienter, demente patienter, psykisk syge patienter, mv). Patienter som ikke giver informeret samtykke. Patienter med kendt overfølsomhed for de aktive stoffer eller hjælpestofferne i Metvix®
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E.5 End points |
E.5.1 | Primary end point(s) |
Det primære effektmål er klinisk behandlingsrespons efter 3 måneder. Det vurderes om læsionen er fuldstændig forsvundet ved behandlingen (complete response) eller ikke helt forsvundet ved behandlingen (non-complete response). |
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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) | 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 | 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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12 måneder efter sidste behandling |
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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 | 10 |
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 |