Calcipotriol and Polymorphic Light Eruption

NCT00871052 | Completed

• 1 other identifier: Graz IRB 19-129 ex 07/08
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Polymorphic Light Eruption

Keywords

Polymorphic light eruption; UV radiation; Vitamin D; Immune suppression; Prevention

Outcome Measures

Primary Outcomes (1)

• Polymorphic light eruption score

  2 weeks

Secondary Outcomes (3)

• Pruritus

  2 weeks

• Erythema

  2 weeks

• Tanning

  2 weeks

Interventions

Calcipotriol-containing cream DRUG

Topical treatment twice a day for 7 days

Also known as: Vitamin D3 analogue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PLE either by typical history and/or typical histology of lesions and/or positive phototesting results
• Age \> 18 years

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University, Department of Dermatology

Graz, A-8036, Austria

Location

Related Publications (1)

• 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.

  PMID: 21428979 DERIVED

Study Officials

• Peter Wolf, MD

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

AU (1)