Calcipotriol and Polymorphic Light Eruption

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00871052
First received: March 27, 2009
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Polymorphic Light Eruption
Drug: Calcipotriol-containing cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Calcipotriol in the Prevention of Polymorphic Light Eruption

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Polymorphic light eruption score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pruritus [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Erythema [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Tanning [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Calcipotriol-containing cream
    Topical treatment twice a day for 7 days
    Other Name: Vitamin D3 analogue
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871052

Locations
Austria
Medical University, Department of Dermatology
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz, Austria
  More Information

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
ClinicalTrials.gov Identifier: NCT00871052     History of Changes
Other Study ID Numbers: Graz IRB 19-129 ex 07/08
Study First Received: March 27, 2009
Last Updated: October 2, 2009
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Polymorphic light eruption
UV radiation
Vitamin D
Immune suppression
Prevention

Additional relevant MeSH terms:
Exanthema
Dermatitis, Contact
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
Vitamin D
Calcitriol
Vitamins
Calcipotriene
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Dermatologic Agents
Therapeutic Uses
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014