E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Development of actinic keratoses and skin cancer in kidney transplant patients - a randomised, intra-individual trial with blinded outcome evaluation. |
Utveckling av aktiniska keratoser och hudcancer hos njurtransplanterade patienter en randomiserad, intra individuell studie med blindad effektutvärdering. |
|
E.1.1.1 | Medical condition in easily understood language |
Development of actinic keratoses and skin cancer in kidney transplant patients. |
Utveckling av aktiniska keratoser och hudcancer hos njurtransplanterade patienter. |
|
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 | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040808 |
E.1.2 | Term | Skin cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047829 |
E.1.2 | Term | Warts (viral) |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
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 |
|
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 |
Number of new skincancer and actinic keratoses in PDT-treated side in relative to untreated side. |
Antal av nytillkomna hudcancer och aktiniska keratoser på
PDT-behandlad sida i relation till obehandlad sida. |
|
E.2.2 | Secondary objectives of the trial |
New warts in PDT-treated side in relative to un-treated control. |
Antal nya vårtor på PDT-behandlad sida i förhållande till obehandlad
kontroll. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who have undergone a kidney transplant at least 1 year ago.
Patients who have given written informed consent and are considered willing to follow the trial protocol.
Patients aged 40 years or older.
Patients with fair skin type defined as Fitzpatrick skin type I-III.
Fertile women must use a reliable form of contraception. |
Patienter som för minst ett år sedan genomgått njurtransplantation.
Patient som har givit sitt skriftliga samtycke att delta och antas vilja följa studieprotokollet.
Patienter över 40 år och äldre.
Patienter med ljus hudtyp definierad som Fitzpatrick hudtyp I-III.
Fertila kvinnor måste använda säkert preventivmedel.
|
|
E.4 | Principal exclusion criteria |
Patients under 40 and over 70 years of age.
Patients who have received PDT treatment in the areas under
investigation.
Patients with dark skin type defined as Fitzpatrick skin type IV-VI.
Patients, have signs of dysplastic skin changes in the areas
under investigation, such as warts, AK, NMSC, Bowen's disease,
keratoacanthoma or infiltrative tumours.
Patients known to have an allergy to any constituents of the MAL cream
Pregnant or breast-feeding patients. |
Patienter under 40 och över 70 års ålder.
Patienter som har fått PDT behandling på de undersökta områdena som
skall undersökas.
Patienter med mörk hud definierad som Fitzpatrick hudtyp IV-VI.
Patienter med tecken på dysplastiska förändringar i områdena
som skall undersökas så som vårtor, AK, NMSC.
Allergi mot något innehåll i MAL krämen
Gravida och ammande patienter. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of newly developed AK or skin cancer in the treatment areas |
Antal nyutvecklade AK eller hudcancer i behandlingsområdena |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT |
6, 12, 18, 24, 30, 36, 42, 48, 54, 60 månader efter första PDT. |
|
E.5.2 | Secondary end point(s) |
Number of newly developed viral warts
Adverse effects such as pigmentary changes and scar
Degree of photodamage and cosmetic outcome |
Antal nyutvecklade virus vårtor i behandlingsområdet
Biverkningar så som som pigmentförändringar, ärr
Grad av solskador och kosmetiskt resultat |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 72 months after first PDT |
6, 12, 18, 24, 30, 36, 42, 48, 54, 60 månader efter första PDT. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | 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 |
Ingen behandling |
No treatment |
|
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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
|
LVLS |
Sista visiten för sista patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |