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Polymorphic Light Eruption | Vitamin D Supplementation in Polymorphic Light Eruption

Polymorphic Light Eruption research study

What is the primary objective of this study?

Polymorphic light eruption (PLE) is a common photodermatosis with a high prevalence of approximately 11 to 21% in the population. Similar to lupus erythematosus (LE), an UV-inducible systemic autoimmune disease, PLE has a female preponderance with a mean onset in the second to third decade of life. PLE lesions are very itchy and typically appear on sun-exposed body sites in spring or early summer. The quality of life in patients with PLE is often severely disturbed, as evidenced by high levels of anxiety and depression. For prophylaxis besides conventional sunscreens, photo(chemo)therapy is effective in many cases, when administered over several weeks for hardening in early spring before the first natural sun exposure takes place. However, because prolonged treatment with UVB and/or photochemotherapy is potentially carcinogenic, the search for pathogenic mechanisms and new treatment options in PLE is ongoing. The exact pathogenesis of PLE is currently unknown but findings suggest an autoimmune-type background with resistance to UV-induced immune suppression and simultaneous immune reactions against skin photo-neoantigens. The investigators have recently found that PLE patients had significantly reduced 1,25-(OH)2-vitamin D3 serum levels (13-14ng/ml) compared to the normal population (>30ng/ml). In addition, the investigators were able to demonstrate in an intra-individual half-body trial that topical administration of an immunostimulatory 1,25-(OH)2-vitamin-D3 analogue calcipotriol reduced PLE symptoms in an experimental study. In the proposed randomized double-blinded placebo-controlled trial the investigators attempt to study the effect of oral vitamin D3 supplementation (2 x 40.000 IE, given orally two weeks apart) on PLE symptoms.

Who is eligible to participate?

Inclusion Criteria: - Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results Exclusion Criteria: - Allergy or intolerance to Oleovit D3 or Coconut/palm kernel - Presence or history of malignant skin tumors - Dysplastic melanocytic nevus syndrome - Photosensitive diseases such as porphyria, chronic actinic dermatitis, xeroderma pigmentosum, and basal cell nevus syndrome; autoimmune disorders such as lupus erythematosus or dermatomyositis - Sarcoid - Renal dysfunction - Psychiatric disorder - Pregnancy or breastfeeding - Topical treatment with vitamin D derivates within 3 months - Oral treatment with vitamin D within 6 months - Antinuclear antibodies such as anti-ds-DNA or anti- Ro/La - 25-hydroxy vitamin D serum levels > 30ng/ml at screening visit - Serum hypercalcemia > 2,65 nmol/L - Treatment with thiazides or glycosides - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Polymorphic Light Eruption

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Oral Vitamin D 340,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)

Drug:Miglyol 812 NNeutral oil of esters extracted from coconut and palm kernel

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Vitamin D3

Placebo

Study Status

Terminated

Start Date: April 2012

Completed Date: May 2015

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: PLE test score (from 0-12) of experimental photo provocation

Secondary Outcome: Cytokine levels in serum

Study sponsors, principal investigator, and references

Principal Investigator: Peter Wolf, MD

Lead Sponsor: Medical University of Graz

Collaborator: Austrian Science Fund (FWF)

More information:https://clinicaltrials.gov/show/NCT01595893

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