Polymorphic Light EruptionNCT00871052
Calcipotriol and Polymorphic Light Eruption
A study testing Calcipotriol-containing cream 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 photodermatosis with an extremely high prevalence, particularly among young women (up to 20%). The disease is characterized through itchy skin lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early summer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polymorphic Light Eruption
- What is being tested?
- Calcipotriol-containing cream
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2009to May 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
- Age > 18 years
Who cannot join
- Presence of or history of malignant skin tumors
- Dysplastic melanocytic nevus syndrome
- Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- Autoimmune disorders such as Lupus erythematosus or dermatomyositis
- Psychiatric disorders
- Immune deficiency or systemic treatment with steroids and/or other immunosuppressive drugs
Show all 11Show fewer
- Pregnancy or lactation
- Antinuclear antibodies
- UV exposure in test fields within 8 weeks before study start
- General poor health status
- Severe liver or renal disease, disorders or therapy of the calcium metabolism with vitamin D containing drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calcipotriol in the Prevention of Polymorphic Light Eruption
Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence, particularly among young women (up to 20%). The disease is characterized through itchy skin lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early summer. Its etiopathogenesis is unknown but resistance to ultraviolet radiation (UVR)-induced immunosuppression with subsequent immune reactions against skin photoneoantigens has been suggested.
The phenomenon of UVR-induced immunosuppression (suppression of CHS) has been well known for many years. Recent findings showed that regulatory T cells (CD4+CD25+FoxP3+) (Tregs), a subset of T helper cells, are crucial in UVR-induced immunosuppression. However, the requirements for the maintenance of peripheral CD4+CD25+ T cells, important in suppression of immune responses, are still incompletely understood. Recent work suggests that cutaneous RANKL might be the physiologic missing link that couples UVR to immunosuppression. Epidermal RANKL, expressed in keratinocytes of inflamed skin due to e.g. UVR exposure was shown to control the number of Tregs via activation of dendritic cells, hereby mediating UVR-induced immunosuppression (e.g. suppression of allergic contact hypersensitivity responses). In addition to the suppression of local cutaneous hyperallergic responses, the development of systemic autoimmunity is suppressed. A strong inducer of RANKL expression and of Tregs is vitamin D3 that has been reported to have immunosuppressive effects. Interestingly, patients with autoimmune disorders (e.g. lupus erythematosus) may exhibit reduced vitamin D3 blood levels.
This randomized, double blinded left-right body side experimental comparison study was designed to assess the preventive effect of the vitamin D3 analogue calcipotriol in patients with PLE. The hypothesis is tested that treatment with a calcipotriol-containing cream can prevent the UVR-induced development of PLE skin lesions. Better insight into the pathogenesis of PLE may give clues to develop new therapeutic strategies.
Read the detailed description
PLE patients will be recruited through the Photodermatology Unit of the Department of Dermatology, Medical University of Graz, Austria. Eligible patients will be identified through diagnosis-related computer-assisted search in the electronic patient chart system of the Unit. The diagnosis of PLE will be verified by patient's history, clinical symptoms, histologic findings, laboratory studies and/or phototesting procedures.
A calcipotriol-cream and a placebo cream are used in this study. Fifteen PLE patients will be enrolled. On day 1, the individual minimal erythema dose (MED) is assessed on patients' skin by exposure to a test ladder of solar-simulated UVR produced by a xenon arc source (Oriel Corp. Darmstadt, Germany). From day 2 to 5, 0.5 individual MED exposures (increased by 0 to 30% per exposure, depending on the erythema response to a preceding dose) are given to a total of four 10-by-10 cm skin test fields on symmetrically located, individual PLE predilection sites on the trunk or extremities. These test fields are pretreated in a randomized and double-blinded fashion either with the calcipotriol cream or the placebo cream (twice a day) during 7 days before start of phototesting.
- Conditions
- Polymorphic Light Eruption
- Being tested
- Calcipotriol-containing cream
- Keywords
- Polymorphic light eruption, UV radiation, Vitamin D, Immune suppression, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol-containing creamDrug
Also called Vitamin D3 analogue
Topical treatment twice a day for 7 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Polymorphic light eruption score
Measured: 2 weeks
Secondary outcomes (3)
Pruritus
Measured: 2 weeks
Erythema
Measured: 2 weeks
Tanning
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871052
- Sponsor's protocol ID
- Graz IRB 19-129 ex 07/08
- Status last verified
- Oct 2009
- First submitted
- 27 Mar 2009
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gruber-Wackernagel A, Bambach I, Legat FJ, Hofer A, Byrne SN, Quehenberger F, Wolf P. Randomized double-blinded placebo-controlled intra-individual trial on topical treatment with a 1,25-dihydroxyvitamin D(3) analogue in polymorphic light eruption. Br J Dermatol. 2011 Jul;165(1):152-63. doi: 10.1111/j.1365-2133.2011.10333.x. Epub 2011 May 30.
PubMed 21428979
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcipotriol in the Prevention of Polymorphic Light Eruption
- ClinicalTrials.gov ID
- NCT00871052
- Acronym / sponsor ID
- Graz IRB 19-129 ex 07/08
- Conditions
- Polymorphic Light Eruption
- Keywords
- Polymorphic light eruption, UV radiation, Vitamin D, Immune suppression, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Mar 2009 (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 photodermatosis with an extremely high prevalence, particularly among young women (up to 20%). The disease is characterized through itchy skin lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early summer. Its etiopathogenesis is unknown but resistance to ultraviolet radiation (UVR)-induced immunosuppression with subsequent immune reactions against skin photoneoantigens has been suggested.
The phenomenon of UVR-induced immunosuppression (suppression of CHS) has been well known for many years. Recent findings showed that regulatory T cells (CD4+CD25+FoxP3+) (Tregs), a subset of T helper cells, are crucial in UVR-induced immunosuppression. However, the requirements for the maintenance of peripheral CD4+CD25+ T cells, important in suppression of immune responses, are still incompletely understood. Recent work suggests that cutaneous RANKL might be the physiologic missing link that couples UVR to immunosuppression. Epidermal RANKL, expressed in keratinocytes of inflamed skin due to e.g. UVR exposure was shown to control the number of Tregs via activation of dendritic cells, hereby mediating UVR-induced immunosuppression (e.g. suppression of allergic contact hypersensitivity responses). In addition to the suppression of local cutaneous hyperallergic responses, the development of systemic autoimmunity is suppressed. A strong inducer of RANKL expression and of Tregs is vitamin D3 that has been reported to have immunosuppressive effects. Interestingly, patients with autoimmune disorders (e.g. lupus erythematosus) may exhibit reduced vitamin D3 blood levels.
This randomized, double blinded left-right body side experimental comparison study was designed to assess the preventive effect of the vitamin D3 analogue calcipotriol in patients with PLE. The hypothesis is tested that treatment with a calcipotriol-containing cream can prevent the UVR-induced development of PLE skin lesions. Better insight into the pathogenesis of PLE may give clues to develop new therapeutic strategies.
Detailed description
PLE patients will be recruited through the Photodermatology Unit of the Department of Dermatology, Medical University of Graz, Austria. Eligible patients will be identified through diagnosis-related computer-assisted search in the electronic patient chart system of the Unit. The diagnosis of PLE will be verified by patient's history, clinical symptoms, histologic findings, laboratory studies and/or phototesting procedures.
A calcipotriol-cream and a placebo cream are used in this study. Fifteen PLE patients will be enrolled. On day 1, the individual minimal erythema dose (MED) is assessed on patients' skin by exposure to a test ladder of solar-simulated UVR produced by a xenon arc source (Oriel Corp. Darmstadt, Germany). From day 2 to 5, 0.5 individual MED exposures (increased by 0 to 30% per exposure, depending on the erythema response to a preceding dose) are given to a total of four 10-by-10 cm skin test fields on symmetrically located, individual PLE predilection sites on the trunk or extremities. These test fields are pretreated in a randomized and double-blinded fashion either with the calcipotriol cream or the placebo cream (twice a day) during 7 days before start of phototesting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
- Age > 18 years
Key exclusion criteria (11 listed)
- Presence of or history of malignant skin tumors
- Dysplastic melanocytic nevus syndrome
- Photosensitive diseases such as porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome, and others
- Autoimmune disorders such as Lupus erythematosus or dermatomyositis
- Psychiatric disorders
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 |
|---|---|---|
| Calcipotriol-containing creamAlso: Vitamin D3 analogueTopical treatment twice a day for 7 days | Drug | – |
Primary outcome
Polymorphic light eruption score
Time frame: 2 weeks
3 secondary outcomes
Pruritus
Time frame: 2 weeks
Erythema
Time frame: 2 weeks
Tanning
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2009.
- Derived from this study: PubMed 21428979Gruber-Wackernagel A, Bambach I, Legat FJ, Hofer A, Byrne SN, Quehenberger F, Wolf P. Randomized double-blinded placebo-controlled intra-individual trial on topical treatment with a 1,25-dihydroxyvitamin D(3) analogue in polymorphic light eruption. Br J Dermatol. 2011 Jul;165(1):152-63. doi: 10.1111/j.1365-2133.2011.10333.x. Epub 2011 May 30.
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 study testing Calcipotriol-containing cream 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 6 Oct 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Polymorphic light eruption score (time frame: 2 weeks). 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 NCT00871052, 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 6 Oct 2009.