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VitD-PLE_2012
Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial
Sponsor study identifier
interventional
8
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 26, 2012
Actual (reported)May 10, 2012
Actual (reported)May 2015
Actual (reported)May 2015
Actual (reported)PLE test score (from 0-12) of experimental photo provocation
See study description.
At day 2, 3, 4, 5, and 8 (change from baseline)
Cytokine levels in serum
At day 22 and 36; and at month 4-8
Chemotaxis of neutrophils
At day 22 and 36; and at month 4-8 (compared to baseline)
Level of regulatory T cells
At day 22 and 36; and at month 4-8 (compared to baseline)
Quantification of skin alterations, including cellular infiltration and cytokine profile
Day 5 and 40
Dermatological quality of life (DLQI)
At month 4-8
40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
Neutral oil of esters extracted from coconut and palm kernel
Medical University of Graz, Department of Dermatology
Graz, A-8036, Austria
Schweintzger NA, Gruber-Wackernagel A, Shirsath N, Quehenberger F, Obermayer-Pietsch B, Wolf P. Influence of the season on vitamin D levels and regulatory T cells in patients with polymorphic light eruption. Photochem Photobiol Sci. 2016 Mar;15(3):440-6. doi: 10.1039/c5pp00398a. Epub 2016 Feb 25.
Peter Wolf, MD
Medical University of Graz
8 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2012
First Posted
May 10, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
June 13, 2016
Record last verified: 2016-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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