Photophoresis Versus Ciclosporine in Severe Atopic Dermat... | NCT02226068

Studies
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis

NCT02226068

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Mar 27, 2015Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Atopic Dermatitis

Interventions

Cyclosporine A (CsA)
Extracorporeal photopheresis (ECP)

Countries

Not provided

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

ID	Type	Description	Link
CsA-ECP	Other Identifier	DermatologyAUH-UK

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Aug 2003Actual

Completion Date

Jan 2004Actual

First Submitted Date

Aug 25, 2014

First Submission Date that Met QC Criteria

Aug 25, 2014

First Posted Date

Aug 26, 2014Estimated

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

Mar 26, 2015

Last Update Posted Date

Mar 27, 2015Estimated

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

Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CsA-ECP	Other	Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given	Drug: Cyclosporine A (CsA) Other: Extracorporeal photopheresis (ECP)
ECP-CsA	Other	Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given	Drug: Cyclosporine A (CsA) Other: Extracorporeal photopheresis (ECP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporine A (CsA)	Drug	3 mg/kg/day for 4 month	CsA-ECP ECP-CsA

Measure	Description	Time Frame
Change of SCORAD (SCORing Atopic Dermatitis)		4 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).

Exclusion Criteria:

Criteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erik Obitz, MD, DMSc	Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016572	Cyclosporine
D017893	Photopheresis

Ancestor Terms

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided