Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis

Phase 2TerminatedNCT00628797

Nicolas Hunzelmann9 enrolled

Overview

Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue involving the skin and internal organs. To date there is no proven therapy for the skin fibrosis available. A number of case reports and small uncontrolled cohort studies suggest that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc using a randomized, intraindividual half body irradiation protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Scleroderma Systemic Sclerosis

Interventions

intraindividual half body irradiation

UVA1OTHER

60 J/cm2 at least 36 tx

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * systemic sclerosis ACR criteria * skin fibrosis at least involving the distal third of the lower arm Exclusion Criteria: * photosensitizing drugs * recent UV therapy

Locations (2)

University of Tuebingen, Dept. of Dermatology

Tübingen, Baden-Wurttemberg, Germany

University of Cologne, Dept. of Dermatology

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

modified skin score

Time frame: 3 months

Secondary Outcomes

modified skin score

Time frame: 6 months

histologic examination

Time frame: 3 months

Data from ClinicalTrials.gov

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