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

Nicolas Hunzelmann

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Systemic Sclerosis; Systemic Scleroderma

Treatments: Other: UVA1

Study type: Interventional

Funder types: Other

Identifiers

NCT00628797

07-200

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

A UVA1 B no UVA1

Other group

Description:

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

Treatment:

Other: UVA1

Other: UVA1

A UVA1

Experimental group

Treatment:

Other: UVA1

Other: UVA1