E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluation of the impact from Polypodium leukotomos Extract on the Prophylaxis of Polymorphic Light Eruption (PMLE)
An investigator initiated, prospective, open label study with an in Austria registered nutricional supplement
|
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the impact of oral administered poplypodium leucotomos extract on the prophylaxis of polymorphic light eruption (PMLE).
Primary criteria: Intensity of skin lesions induced by Photoprovocation: Sum of number of papules, vesicles and plaques.
|
|
E.2.2 | Secondary objectives of the trial |
Secondary criteria: Duration until raise of papules, vesicles and plaques. Intensity of itching. Duration until raising of itching . Intensity of erythema. Duration until raising of eriyhema.
|
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient selection criteria: Patients with anamnesis and medication according PMLE are invited to take part in this trial.
Inclusion criteria: Man and women ≥18a, <65a; via anamnesis and/or photoprovocation approved diagnosis of PMLE, negative pregnancy testing for women of childbearing potential.
|
|
E.4 | Principal exclusion criteria |
Exclusion criteria: Age <18a, >65a; other photodermatosis or photosensitive disease; current treatment with systemic corticosteroids, antihistamins, immunsupressiv acting agents; phototherapy or photochemotherapy within the last 8 weeks; participation in another clinical trial; active infections; pregnancy; breast feeding women.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary criteria: Intensity of skin lesions induced by Photoprovocation: Sum of number of papules, vesicles and plaques.
Study parameters: - Erythema yes/no if yes: slight/medium/severe - Papules yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Vesicles yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Plaques yes/no if yes: 1 – 10 / > 10 – 30 / > 30 - Itching tested via Visual Analogue Scale
Evaluated will be Intensity and Duration until raise of PMLE läsions during first and second phase of Photoprovocation testing. First testing without second testing under intake of study drug.
|
|
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 | 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 | 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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
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 | No |
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 | Yes |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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
|
First Pat In: 04/2006 Last Pat Out: 07/2006
|
|
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 | 3 |
E.8.9.1 | In the Member State concerned days | |