Effectiveness of UVA1-irradiation in the Treatment of Ear... | NCT00628797

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

NCT00628797

Sponsor

Nicolas Hunzelmann

Status

Terminated

Last Update Posted

May 31, 2017Actual

Enrollment

9Actual

Phase

Phase 1Phase 2

Conditions

Systemic Scleroderma
Systemic Sclerosis

Interventions

UVA1
UVA1

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitement

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2013Actual

First Submitted Date

Feb 26, 2008

First Submission Date that Met QC Criteria

Feb 26, 2008

First Posted Date

Mar 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2017

Last Update Posted Date

May 31, 2017Actual

Name	Class
University Hospital Tuebingen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UVA1	Radiation	intraindividual half body irradiation	A UVA1	ultraviolet light

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
modified skin score		3 months

Secondary Outcomes

Measure	Description	Time Frame
modified skin score		6 months
histologic examination		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas Hunzelmann	University of Cologne, Dept. of Dermatology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tuebingen, Dept. of Dermatology		Tübingen	Baden-Wurttemberg	72076	Germany
University of Cologne, Dept. of Dermatology

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014466	Ultraviolet Rays

Ancestor Terms

ID	Term
D008027	Light
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided