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Vitamin D Supplementation in Polymorphic Light Eruption (VitD-PLE_2012)

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ClinicalTrials.gov Identifier: NCT01595893
Recruitment Status : Terminated (Difficulties in recruiting the planned number of patients)
First Posted : May 10, 2012
Last Update Posted : June 13, 2016
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polymorphic Light Eruption Drug: Oral Vitamin D 3 Drug: Miglyol 812 N Phase 3

Detailed Description:

PLE patients will be subjected to experimental photo provocation with solar simulated UV radiation over several days before and after vitamin D3 supplementation. Disease symptoms will be quantified with a newly established and validated PLE test score, (AA + SI + 0.4P [range, 0-12], where AA is affected area score [range, 0-4], SI is skin infiltration score [range, 0-4], and P is pruritus score on a visual analogue scale [range, 0-10]). Optional biopsies will be taken to investigate the effect of oral vitamin D3 on UV-induced skin test sites, including cellular skin infiltration and expression and release of cytokines in situ as endpoints. We will also study the effect of oral vitamin D3 on abnormalities i) of levels and function of regulatory T cells, ii) chemotaxis of leucocytes, and iii) proinflammatory cytokines, i.e. alterations that have been previously linked to PLE pathogenesis. This will be done by i) FACS and co-culture T cell proliferation assays, ii) response of peripheral neutrophil leucocytes to the chemoattractants leukotriene B4 (LTB4) and formyl-methionyl-leucyl-phenylalanine, and iii) ELISA and immunobead assay of patient serum.

To back-up the results obtained with the PLE test score upon experimental photo provocation the study participants will receive a questionnaire on PLE symptoms and quality of life, adapted from scores as previously described. This questionnaire will allow monitoring PLE symptoms and quality of life in the patients during the summer season following the oral vitamin D3 supplementation in spring.

The results of the project will enlighten the mechanism of PLE and may establish the base of a novel prevention strategy via the vitamin D3 pathway.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial
Study Start Date : April 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3 Drug: Oral Vitamin D 3
40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
Other Name: Oleovit D3, Fresenius Kabi, Austria

Placebo Comparator: Placebo Drug: Miglyol 812 N
Neutral oil of esters extracted from coconut and palm kernel
Other Name: Vegetable oil

Primary Outcome Measures :
  1. PLE test score (from 0-12) of experimental photo provocation [ Time Frame: At day 2, 3, 4, 5, and 8 (change from baseline) ]
    See study description.

Secondary Outcome Measures :
  1. Cytokine levels in serum [ Time Frame: At day 22 and 36; and at month 4-8 ]
  2. Chemotaxis of neutrophils [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ]
  3. Level of regulatory T cells [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ]
  4. Quantification of skin alterations, including cellular infiltration and cytokine profile [ Time Frame: Day 5 and 40 ]
  5. Dermatological quality of life (DLQI) [ Time Frame: At month 4-8 ]
  6. HADS (hospital anxiety and depression scale) [ Time Frame: At month 4-8 ]
  7. Function of regulatory T cells [ Time Frame: 22 and 36; and at month 4-8 (compared to baseline) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595893

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Medical University of Graz, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Austrian Science Fund (FWF)
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Principal Investigator: Peter Wolf, MD Medical University of Graz
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01595893    
Other Study ID Numbers: Graz 24-220 ex 11/12
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Keywords provided by Medical University of Graz:
Polymorphic light eruption
Vitamin D3
Photo provocation
Immune function
Additional relevant MeSH terms:
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Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents