Trial record 5 of 111 for:    Open Studies | "Exanthema"

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

This study is currently recruiting participants.
Verified November 2013 by Medical University of Graz
Sponsor:
Collaborator:
Austrian Science Fund (FWF)
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01595893
First received: April 26, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Polymorphic Light Eruption
Drug: Oral Vitamin D 3
Drug: Miglyol 812 N
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • PLE test score (from 0-12) of experimental photo provocation [ Time Frame: At day 2, 3, 4, 5, and 8 (change from baseline) ] [ Designated as safety issue: No ]
    See study description.


Secondary Outcome Measures:
  • Cytokine levels in serum [ Time Frame: At day 22 and 36; and at month 4-8 ] [ Designated as safety issue: No ]
  • Chemotaxis of neutrophils [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ] [ Designated as safety issue: No ]
  • Level of regulatory T cells [ Time Frame: At day 22 and 36; and at month 4-8 (compared to baseline) ] [ Designated as safety issue: No ]
  • Quantification of skin alterations, including cellular infiltration and cytokine profile [ Time Frame: Day 5 and 40 ] [ Designated as safety issue: No ]
  • Dermatological quality of life (DLQI) [ Time Frame: At month 4-8 ] [ Designated as safety issue: No ]
  • HADS (hospital anxiety and depression scale) [ Time Frame: At month 4-8 ] [ Designated as safety issue: No ]
  • Function of regulatory T cells [ Time Frame: 22 and 36; and at month 4-8 (compared to baseline) ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595893

Contacts
Contact: Peter Wolf, MD +43 316-385 ext 80315 peter.wolf@medunigraz.at
Contact: Alexandra Gruber-Wackernagel, MD+ +43 316 385 ext 13254 alexandra.wackernagel@medunigraz.at

Locations
Austria
Medical University of Graz, Department of Dermatology Recruiting
Graz, Austria, A-8036
Contact: Alexandra Gruber-Wackernagel, MD    +43 316-385 ext 13254    alexandra.wackernagel@medunigraz.at   
Contact: Peter Wolf, MD+    +43 316-385 ext 80315    peter.wolf@medunigraz.at   
Principal Investigator: Peter Wolf, MD         
Sub-Investigator: Alexandra Gruber-Wackernagel, MD         
Sub-Investigator: Angelika Hofer, MD         
Sub-Investigator: Isabella Bambach         
Sub-Investigator: Helga Pressl, Mag.         
Sub-Investigator: Martin Inzinger, MD         
Sub-Investigator: Franz Legat, MD         
Sub-Investigator: Barbara Obermayer-Pietsch, MD         
Sponsors and Collaborators
Medical University of Graz
Austrian Science Fund (FWF)
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01595893     History of Changes
Other Study ID Numbers: Graz 24-220 ex 11/12
Study First Received: April 26, 2012
Last Updated: November 4, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Polymorphic light eruption
Vitamin D3
Photo provocation
Immune function

Additional relevant MeSH terms:
Exanthema
Dermatitis, Contact
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 22, 2014