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

N

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

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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