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

Phase 1

Terminated

• Conditions: Systemic Scleroderma; Systemic Sclerosis

• Registration Number: NCT00628797
• Lead Sponsor: Nicolas Hunzelmann

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-03-05
• Primary Completion: 2010-07
• Study Completion: 2013-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
modified skin score	3 months

Secondary Outcome Measures

Name	Time	Method
modified skin score	6 months
histologic examination	3 months

Trial Locations

Locations (2)

University of Tuebingen, Dept. of Dermatology; 🇩🇪 Tuebingen, BW, Germany

University of Cologne, Dept. of Dermatology; 🇩🇪 Cologne, NRW, Germany