Polymorphic Light EruptionPhase 3VitD-PLE_2012NCT01595893
Vitamin D Supplementation in Polymorphic Light Eruption
A Phase 3 study testing Oral Vitamin D 3 and Miglyol 812 N in people with Polymorphic Light Eruption, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- Oral Vitamin D 3 and Miglyol 812 N
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2012to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department of Dermatology
Graz, A-8036
About this study
Official title: Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial
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.
Read the 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.
- Conditions
- Polymorphic Light Eruption
- Being tested
- Oral Vitamin D 3, Miglyol 812 N
- Keywords
- Polymorphic light eruption, Vitamin D3, Photo provocation, Immune function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Vitamin D 3Drug
Also called Oleovit D3, Fresenius Kabi, Austria
40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
Miglyol 812 NDrug
Also called Vegetable oil
Neutral oil of esters extracted from coconut and palm kernel
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Not described Receives: Drug: Oral Vitamin D 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Miglyol 812 N |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLE test score (from 0-12) of experimental photo provocation
See study description.
Measured: At day 2, 3, 4, 5, and 8 (change from baseline)
Secondary outcomes (7)
Cytokine levels in serum
Measured: At day 22 and 36; and at month 4-8
Chemotaxis of neutrophils
Measured: At day 22 and 36; and at month 4-8 (compared to baseline)
Level of regulatory T cells
Measured: At day 22 and 36; and at month 4-8 (compared to baseline)
Quantification of skin alterations, including cellular infiltration and cytokine profile
Measured: Day 5 and 40
Dermatological quality of life (DLQI)
Measured: At month 4-8
HADS (hospital anxiety and depression scale)
Measured: At month 4-8
Function of regulatory T cells
Measured: 22 and 36; and at month 4-8 (compared to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Difficulties in recruiting the planned number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polymorphic Light EruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Responsible party
- Sponsor
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595893
- Sponsor's protocol ID
- Graz 24-220 ex 11/12
- Acronym
- VitD-PLE_2012
- Status last verified
- Jun 2016
- First submitted
- 26 Apr 2012
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26911519
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Supplementation in Polymorphic Light Eruption: Randomized Double-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01595893
- Acronym / sponsor ID
- VitD-PLE_2012 / Graz 24-220 ex 11/12
- Conditions
- Polymorphic Light Eruption
- Keywords
- Polymorphic light eruption, Vitamin D3, Photo provocation, Immune function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting the planned number of patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Oral Vitamin D 3 |
| Placebo | Placebo comparator | Drug: Miglyol 812 N |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed diagnosis of PLE by typical patient history, typical histology of skin lesions and/or positive photo provocation results
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Vitamin D 3Also: Oleovit D3, Fresenius Kabi, Austria40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart) | Drug | Vitamin D3 |
| Miglyol 812 NAlso: Vegetable oilNeutral oil of esters extracted from coconut and palm kernel | Drug | Placebo |
Primary outcome
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.
7 secondary outcomes
Cytokine levels in serum
Time frame: At day 22 and 36; and at month 4-8
Chemotaxis of neutrophils
Time frame: At day 22 and 36; and at month 4-8 (compared to baseline)
Level of regulatory T cells
Time frame: At day 22 and 36; and at month 4-8 (compared to baseline)
Quantification of skin alterations, including cellular infiltration and cytokine profile
Time frame: Day 5 and 40
Dermatological quality of life (DLQI)
Time frame: At month 4-8
HADS (hospital anxiety and depression scale)
Time frame: At month 4-8
Function of regulatory T cells
Time frame: 22 and 36; and at month 4-8 (compared to baseline)
Results and safety
The study was stopped early (reason given: Difficulties in recruiting the planned number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Derived from this study: PubMed 26911519Schweintzger 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wolf, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Vitamin D 3 and Miglyol 812 N in people with Polymorphic Light Eruption, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting the planned number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLE test score (from 0-12) of experimental photo provocation (time frame: At day 2, 3, 4, 5, and 8 (change from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.