Calcipotriol and Polymorphic Light Eruption

Sponsor

Medical University of Graz (Other)

Overall Status

Completed

CT.gov ID

NCT00871052

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polymorphic Light Eruption	Drug: Calcipotriol-containing cream	N/A

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

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Calcipotriol in the Prevention of Polymorphic Light Eruption

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Outcome Measures

Primary Outcome Measures

Polymorphic light eruption score [2 weeks]

Secondary Outcome Measures

Pruritus [2 weeks]
Erythema [2 weeks]
Tanning [2 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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