Vitamin D supplementation in polymorphic light eruption: Randomized double-blinded placebo-controlled trial - Vitamin D and PLE

Phase 1

Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Polymorphic light eruption
MedDRA version: 14.1Level: PTClassification code 10051246Term: PhotodermatosisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Registration Number: EUCTR2012-000300-15-AT

Lead Sponsor: Medizinische Universität Graz, Univ. Klinik Dermatologie, Forschungseinheit für Photodermatologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether oral vitamin D supplementation abrogates the pathogenic mechanisms in PLE and prevents the manifestation of the disease.;Secondary Objective: not applicable;Primary end point(s): PLE test score of experimental photoprovocation;Timepoint(s) of evaluation of this end point: up to 3 years after start of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Clinical endpoints:<br>- PLE symptoms, quality of life, and HADS upon exposure to natural sun light during spring and summer<br>Laboratory endpoints:<br>- Quantification of histologic alterations<br>- Cytokine levels in serum<br>- Level and function of regulatory T cells (Tregs)<br>- Chemotaxis of neutrophils<br>;Timepoint(s) of evaluation of this end point: up to 3 years after start of study