Systemic SclerodermaPhase 1/2NCT00628797
Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis
A Phase 1/2 study testing UVA1 in people with Systemic Scleroderma and Systemic Sclerosis, run by Nicolas Hunzelmann at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Scleroderma, Systemic Sclerosis
- What is being tested?
- UVA1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2008to Nov 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- systemic sclerosis ACR criteria
- skin fibrosis at least involving the distal third of the lower arm
Who cannot join
- photosensitizing drugs
- recent UV therapy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Cologne, Dept. of Dermatology
Cologne, North Rhine-Westphalia, 50937
University of Tuebingen, Dept. of Dermatology
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie
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
- Systemic Scleroderma, Systemic Sclerosis
- Being tested
- UVA1
- Keywords
- systemic sclerosis, skin fibrosis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UVA1Radiation
Also called ultraviolet light
intraindividual half body irradiation
UVA1Other
Also called Ultraviolet light
60 J/cm2 at least 36 tx
| Study group | Role | What they receive |
|---|---|---|
| A UVA1 B no UVA1 | Other | half body irradiation with random allocation right and left; after three months of treatment treatment of both sides Receives: Other: UVA1 |
| A UVA1 | Experimental | Not described Receives: Radiation: UVA1; Other: UVA1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified skin score
Measured: 3 months
Secondary outcomes (2)
modified skin score
Measured: 6 months
histologic examination
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2010
- Study completionNov 2013
Why it stopped: lack of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolas Hunzelmann
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor-investigator, Nicolas Hunzelmann, University of Cologne
- Investigators
- Nicolas Hunzelmann, Principal investigator, University of Cologne, Dept. of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628797
- Sponsor's protocol ID
- 07-200
- Status last verified
- May 2017
- First submitted
- 26 Feb 2008
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multizenter-Studie Zur UVA-1 Therapie für Die Hautbeteiligung Bei Systemischer Sklerodermie
- ClinicalTrials.gov ID
- NCT00628797
- Acronym / sponsor ID
- 07-200
- Conditions
- Systemic Scleroderma, Systemic Sclerosis
- Keywords
- systemic sclerosis, skin fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitement
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nicolas HunzelmannUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Feb 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A UVA1 B no UVA1 | Other | Other: UVA1half body irradiation with random allocation right and left; after three months of treatment treatment of both sides |
| A UVA1 | Experimental | Radiation: UVA1, Other: UVA1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- systemic sclerosis ACR criteria
- skin fibrosis at least involving the distal third of the lower arm
Key exclusion criteria (2 listed)
- photosensitizing drugs
- recent UV therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UVA1Also: ultraviolet lightintraindividual half body irradiation | Radiation | A UVA1 |
| UVA1Also: Ultraviolet light60 J/cm2 at least 36 tx | Other | A UVA1, A UVA1 B no UVA1 |
Primary outcome
modified skin score
Time frame: 3 months
2 secondary outcomes
modified skin score
Time frame: 6 months
histologic examination
Time frame: 3 months
Results and safety
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Hunzelmann principal investigator
University of Cologne, Dept. of Dermatology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UVA1 in people with Systemic Scleroderma and Systemic Sclerosis, run by Nicolas Hunzelmann at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified skin score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.