TerminatedNCT00628797Updated May 31, 2017

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

A Phase 1/2 interventional study of UVA1 and UVA1 in Systemic Scleroderma and Systemic Sclerosis, sponsored by Nicolas Hunzelmann. Terminated at 2 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-05-31.

Sponsored by Nicolas Hunzelmann · Phase 1/2, Interventional, and Treatment

Why this study was terminated

lack of recruitement

Phase: Phase 1/2
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Systemic Scleroderma
Systemic Sclerosis

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Keywords

systemic sclerosis
skin fibrosis

In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's enrollment of 9 is below the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.

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Lead sponsor

This is the only study on the registry with Nicolas Hunzelmann as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

systemic sclerosis ACR criteria
skin fibrosis at least involving the distal third of the lower arm

Exclusion criteria

Exclusion Criteria:

photosensitizing drugs
recent UV therapy

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 9 participants (actual)

Study arms

Other
A UVA1 B no UVA1
half body irradiation with random allocation right and left; after three months of treatment treatment of both sides
Other: UVA1
Experimental
A UVA1
Radiation: UVA1 · Other: UVA1

Interventions

RadiationUVA1
intraindividual half body irradiation
Also known as: ultraviolet light
OtherUVA1
60 J/cm2 at least 36 tx
Also known as: Ultraviolet light

What researchers measure

Primary outcomes

modified skin score
Time frame: 3 months

Secondary outcomes

modified skin score
Time frame: 6 months
histologic examination
Time frame: 3 months

Study locations

2 sites

University of Tuebingen, Dept. of Dermatology
Tuebingen, BW 72076, Germany
University of Cologne, Dept. of Dermatology
Cologne, NRW 50937, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00628797
Lead sponsor: Nicolas Hunzelmann
Collaborators: University Hospital Tuebingen
Responsible party: Nicolas Hunzelmann (Prof. Dr. N. Hunzelmann, University of Cologne) — Sponsor-investigator
First posted: Mar 5, 2008
Start date: Feb 2008
Primary completion: Jul 2010
Completion: Nov 2013
Last update: May 31, 2017

Study contacts

Nicolas Hunzelmann

principal investigator · University of Cologne, Dept. of Dermatology

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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