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

May 29, 2017 updated by: Nicolas Hunzelmann

Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tuebingen, BW, Germany, 72076
        • University of Tuebingen, Dept. of Dermatology
    • NRW
      • Cologne, NRW, Germany, 50937
        • University of Cologne, Dept. of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A UVA1 B no UVA1
half body irradiation with random allocation right and left; after three months of treatment treatment of both sides
Other: UVA1
60 J/cm2 at least 36 tx
Other Names:
  • Ultraviolet light
Experimental: A UVA1
Other: UVA1
60 J/cm2 at least 36 tx
Other Names:
  • Ultraviolet light
Radiation: UVA1
intraindividual half body irradiation
Other Names:
  • ultraviolet light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified skin score
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
modified skin score
Time Frame: 6 months
6 months
histologic examination
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas Hunzelmann

Collaborators

University Hospital Tuebingen

Investigators

  • Principal Investigator: Nicolas Hunzelmann, University of Cologne, Dept. of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 29, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Sclerosis

Clinical Trials on UVA1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe