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

Primary Purpose

Systemic Scleroderma, Systemic Sclerosis

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

UVA1

About this trial

This is an interventional treatment trial for Systemic Scleroderma focused on measuring systemic sclerosis, skin fibrosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Tuebingen, Dept. of Dermatology
University of Cologne, Dept. of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

A UVA1 B no UVA1

A UVA1

Arm Description

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

Outcomes

Primary Outcome Measures

modified skin score

Secondary Outcome Measures

modified skin score

histologic examination

Full Information

NCT ID

NCT00628797

First Posted

February 26, 2008

Last Updated

May 29, 2017

Sponsor

Nicolas Hunzelmann

Collaborators

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT00628797

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

lack of recruitement

Study Start Date

February 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nicolas Hunzelmann

Collaborators

University Hospital Tuebingen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Scleroderma, Systemic Sclerosis

Keywords

systemic sclerosis, skin fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A UVA1 B no UVA1

Arm Type

Other

Arm Description

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

Arm Title

A UVA1

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

UVA1

Other Intervention Name(s)

ultraviolet light

Intervention Description

intraindividual half body irradiation

Intervention Type

Other

Intervention Name(s)

UVA1

Other Intervention Name(s)

Ultraviolet light

Intervention Description

60 J/cm2 at least 36 tx

Primary Outcome Measure Information:

Title

modified skin score

Time Frame

3 months

Secondary Outcome Measure Information:

Title

modified skin score

Time Frame

6 months

Title

histologic examination

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Hunzelmann

Organizational Affiliation

University of Cologne, Dept. of Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Tuebingen, Dept. of Dermatology

City

Tuebingen

State/Province

ZIP/Postal Code

72076

Country

Germany

Facility Name

University of Cologne, Dept. of Dermatology

City

Cologne

State/Province

NRW

ZIP/Postal Code

50937

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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