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

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00628797
• Other study ID #: 07-200
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 26, 2008
• Last updated: May 29, 2017
• Start date: February 2008
• Est. completion date: November 2013

Study information

• Verified date: May 2017
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 2013
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Scleroderma
• Systemic Sclerosis

Intervention

Radiation:
• UVA1
intraindividual half body irradiation

Other:
• UVA1
60 J/cm2 at least 36 tx

Locations

Country	Name	City	State
Germany	University of Cologne, Dept. of Dermatology	Cologne	NRW
Germany	University of Tuebingen, Dept. of Dermatology	Tuebingen	BW

Sponsors (2)

Lead Sponsor	Collaborator
Nicolas Hunzelmann	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified skin score		3 months
Secondary	modified skin score		6 months
Secondary	histologic examination		3 months