NCT02226068

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
Last Updated

March 27, 2015

Status Verified

August 1, 2014

Enrollment Period

1.2 years

First QC Date

August 25, 2014

Last Update Submit

March 26, 2015

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitisCiclosporineExtracorporal photopheresis

Outcome Measures

Primary Outcomes (1)

  • Change of SCORAD (SCORing Atopic Dermatitis)

    4 month

Study Arms (2)

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

Cyclosporine A (CsA)DRUG

3 mg/kg/day for 4 month

Also known as: Sandimmune
CsA-ECPECP-CsA
Extracorporeal photopheresis (ECP)OTHER

Administered two consecutive days twice a month for 4 month

CsA-ECPECP-CsA

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

CyclosporinePhotopheresis

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Erik Obitz, MD, DMSc

    Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 26, 2014

Study Start

June 1, 2002

Primary Completion

August 1, 2003

Study Completion

January 1, 2004

Last Updated

March 27, 2015

Record last verified: 2014-08