E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
actinic keratosis |
aktinische Keratosen |
|
E.1.1.1 | Medical condition in easily understood language |
superficial skin cancer |
oberflächlichler Hautkrebs |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
To evaluate the influence of a single dose of diclofenac on pain development during photodynamic therapy |
Den Einfluss von Einmaldosis von Diclofenac auf die Schmerzentwicklung während der PDT zu evaluieren |
|
E.2.2 | Secondary objectives of the trial |
to evaluate whether the methods used for pain reduction have an impact on the severity of the local skin reaction or the long-term response rates. in addition, to evaluate the cosmetic outcome and the patients`global satisfaction with the treatment |
zu evaluieren, ob sich die Interventionen zur Schmerzreduktion hinsichtlich der Intensität der phototoxischen Hautreaktion und der Abheilungsraten der Läsionen unterscheiden. Weitere sekundäre Zielparameter sind das kosmetische Ergebnis und die globale Patientenzufriedenheit. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients with actinic keratoses on the head; age 18 years or older |
Patienten mit aktinischen Keratosen im Kopfbereich; Alter gleich oder größer 18 Jahre |
|
E.4 | Principal exclusion criteria |
intolerance to topically applied aminolevulinic acid; intolerance or allergy to diclofenac; florid and untreated gastric or duodenal ulcer |
Intoleranz von topisch applizierter Aminolävulinsäure; Intoleranz oder Allergie von/auf Diclofenac; unbehandeltes oder florides Magen- oder Zwölffingerdarmgeschwür |
|
E.5 End points |
E.5.1 | Primary end point(s) |
median pain score during and after PDT treatment |
Medianer Schmerzwert während und nach der PDT |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1, 5, 9, 13 and 17 minutes after initiation of PDT and 10, 20 ad 30 minutes after end of treatment |
1, 5, 9, 13 und 17 min nach Beginn der Bestrahlung sowie 10, 20 und 30 Minuten nach Beendigung der Therapie |
|
E.5.2 | Secondary end point(s) |
- the intensity of the local skin reaction
- the rate of complete response
- rhe cosmetic outcome
- patients` global satisfaction with the treatment |
- die Intensität der lokalen Hautreaktion
- die Abheilungsrate
- das kosmetische Ergebnis
- die Beurteilung der globalen Patientenzufriedenheit |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- immediately, 30 min, 2 and 7 days after PDT
- 3, 6 and 12 months after PDT
- 12 months after PDT
- 12 months after PDT |
- unmittelbar, 30 min sowie und 2 und 7 Tage nach der PDT;
- 3, 6 Monate und 12 Monate nach der PDT;
- nach 12 Monaten
- nach 12 Monaten |
|
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 | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Voltaren 50mg rapid |
Voltaren 50mg rapid |
|
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
|
LVLS |
Letzte Visite des letzten Patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |