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

NCT ID: NCT00628797

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Scleroderma Systemic Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A UVA1 B no UVA1

half body irradiation with random allocation right and left; after three months of treatment treatment of both sides

Group Type OTHER

UVA1

Intervention Type OTHER

60 J/cm2 at least 36 tx

A UVA1

Group Type EXPERIMENTAL

UVA1

Intervention Type RADIATION

intraindividual half body irradiation

UVA1

Intervention Type OTHER

60 J/cm2 at least 36 tx

Interventions

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UVA1

intraindividual half body irradiation

Intervention Type RADIATION

UVA1

60 J/cm2 at least 36 tx

Intervention Type OTHER

Other Intervention Names

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ultraviolet light Ultraviolet light

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Nicolas Hunzelmann

OTHER

Sponsor Role lead

Responsible Party

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Nicolas Hunzelmann

Prof. Dr. N. Hunzelmann

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nicolas Hunzelmann

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Dept. of Dermatology

Locations

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University of Tuebingen, Dept. of Dermatology

Tübingen, Baden-Wurttemberg, Germany

Site Status

University of Cologne, Dept. of Dermatology

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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07-200

Identifier Type: -

Identifier Source: org_study_id

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