E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polymorphic light eruption |
Polymorphe Lichtdermatose |
|
E.1.1.1 | Medical condition in easily understood language |
photodermatosis |
Photodermatose, "Sonnenallergie" |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051246 |
E.1.2 | Term | Photodermatosis |
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 |
To determine whether oral vitamin D supplementation abrogates the pathogenic mechanisms in PLE and prevents the manifestation of the disease. |
Es soll untersucht werden ob die Gabe von Vitamin D die Entstehungsmechanismen der Polymorphen Lichtdermatose beeinflusst und das Auftreten der Erkrankung verhindert. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age greater than 18 years and below 75 years
confirmed diagnosis of polymorphic light eruption by typical patient history and/or typical histology of skin lesions and/or positive photoprovocation results |
|
E.4 | Principal exclusion criteria |
Allergy or intolerance to Oleovit Vitamin D3 or Coconut
presence or history of malignant skin tumors,
dysplastic melanocytic nevus syndrome,
photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, basal cell nevus syndrome;
renal dysfunction, Sarcoid,
autoimmune disorders such as lupus erythematosus or dermatomyositis, psychiatric disorders, pregnancy or breast feeding, antinuclear antibodies such as anti-ds-DNA or anti-Ro/La, topical treatment with vitamin D derivates within 3 months, oral treatment with vitamin D within 6 months, 25-OH vitamin D levels > 30 ng/ml at screening visit, systemic treatment with steroids and/or other immunosuppressive drugs within 4 weeks, UV exposure in test fields within 8 weeks before the start of the study, general poor health status, treatment with thiazides or glycosides, serum hypercalcemia > 2,65 nmol/l |
|
E.5 End points |
E.5.1 | Primary end point(s) |
PLE test score of experimental photoprovocation |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
up to 3 years after start of study |
|
E.5.2 | Secondary end point(s) |
Clinical endpoints:
- PLE symptoms, quality of life, and HADS upon exposure to natural sun light during spring and summer
Laboratory endpoints:
- Quantification of histologic alterations
- Cytokine levels in serum
- Level and function of regulatory T cells (Tregs)
- Chemotaxis of neutrophils
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to 3 years after start of study |
|
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 | 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) | 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 | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |