Atopic DermatitisNCT02226068
Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis
A study testing Cyclosporine A (CsA) and Extracorporeal photopheresis (ECP) in people with Atopic Dermatitis, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cyclosporine A (CsA) and Extracorporeal photopheresis (ECP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jan 2004
- Phase
- Interventional
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).
Who cannot join
- 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.
About this study
Official title: Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Cyclosporine A (CsA), Extracorporeal photopheresis (ECP)
- Keywords
- Atopic dermatitis, Ciclosporine, Extracorporal photopheresis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine A (CsA)Drug
Also called Sandimmune
3 mg/kg/day for 4 month
Extracorporeal photopheresis (ECP)Other
Administered two consecutive days twice a month for 4 month
| Study group | Role | What they receive |
|---|---|---|
| CsA-ECP | Other | Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given Receives: 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 Receives: Drug: Cyclosporine A (CsA); Other: Extracorporeal photopheresis (ECP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of SCORAD (SCORing Atopic Dermatitis)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJun 2002
- Primary completionAug 2003
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Obitz, MD, DMSc, Principal investigator, Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226068
- Sponsor's protocol ID
- CsAvsECP-AUH
- Other IDs
- CsA-ECP
- Status last verified
- Aug 2014
- First submitted
- 25 Aug 2014
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities
- ClinicalTrials.gov ID
- NCT02226068
- Acronym / sponsor ID
- CsAvsECP-AUH
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Ciclosporine, Extracorporal photopheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 26 Aug 2014 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CsA-ECP | Other | Drug: Cyclosporine A (CsA), Other: Extracorporeal photopheresis (ECP)Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given |
| ECP-CsA | Other | Drug: Cyclosporine A (CsA), Other: Extracorporeal photopheresis (ECP)Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Criteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Cyclosporine A (CsA)Also: Sandimmune3 mg/kg/day for 4 month | Drug | CsA-ECP, ECP-CsA |
| Extracorporeal photopheresis (ECP)Administered two consecutive days twice a month for 4 month | Other | CsA-ECP, ECP-CsA |
Primary outcome
Change of SCORAD (SCORing Atopic Dermatitis)
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
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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.
Erik Obitz, MD, DMSc principal investigator
Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Cyclosporine A (CsA) and Extracorporeal photopheresis (ECP) in people with Atopic Dermatitis, run by University of Aarhus.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of SCORAD (SCORing Atopic Dermatitis) (time frame: 4 month). 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 27 Mar 2015.