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Calcipotriol in the Prevention of Polymorphic Light Eruption
Sponsor study identifier
interventional
13
1 country
1
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
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.
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 27, 2009
Actual (reported)March 30, 2009
Actual (reported)May 2009
Actual (reported)May 2009
Actual (reported)Polymorphic light eruption score
2 weeks
Pruritus
2 weeks
Erythema
2 weeks
Tanning
2 weeks
Topical treatment twice a day for 7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical University, Department of Dermatology
Graz, A-8036, Austria
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.
Peter Wolf, MD
Medical University of Graz
13 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2009
First Posted
March 30, 2009
Study Start
March 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
October 6, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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