Dermatitis, AtopicNCT00616096
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
A study testing immunoadsorption in people with Dermatitis, Atopic, run by University of Luebeck at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- immunoadsorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atopical dermatitis
- Total serum IgE level above 5000 kU/l
- IGA score of 3 or above
- No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
- 18 years of age or above
- Effective contraception during therapy
- Informed consent
Who cannot join
- Unfavorable conditions for peripheral venous access
- Known hypersensitivity or allergy towards materials used in the adsorber columns
- Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
- Extreme bleeding tendency during anticoagulation
- Hypercoagulability
- Severe cardiovascular disease forbidding extracorporeal circulation
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- Severe systemic infection
- Serum IgG level below 250 mg/dl
- Severe immunodeficiency (e.g. AIDS)
- Treatment with an ACE inhibitor (discontinue drug at least 72 h before treatment)
- Pregnancy
- Lactation
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, University of Lübeck
Lübeck, Schleswig-Holstein, 23538
About this study
The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.
- Conditions
- Dermatitis, Atopic
- Being tested
- immunoadsorption
- Keywords
- Serum Immunoglobulin E above 5000 kU/l
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoadsorptionProcedure or surgery
First cycle: week 1, day 1-5
Second cycle: week 5, day 1-5
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: immunoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.
Measured: 13 weeks
Secondary outcomes (1)
Evidence of reduction of concomitant topical and/or systemic medication.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Investigators
- Detlef Zillikens, M. D., Study chair, Department of Dermatology, University of Lübeck, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616096
- Sponsor's protocol ID
- IAAD01
- Other IDs
- AZ07-111
- Status last verified
- Jan 2010
- First submitted
- 4 Feb 2008
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
- ClinicalTrials.gov ID
- NCT00616096
- Acronym / sponsor ID
- IAAD01
- Conditions
- Dermatitis, Atopic
- Keywords
- Serum Immunoglobulin E above 5000 kU/l
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Feb 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.
The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: immunoadsorption |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Atopical dermatitis
- Total serum IgE level above 5000 kU/l
- IGA score of 3 or above
- No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
- 18 years of age or above
Key exclusion criteria (13 listed)
- Unfavorable conditions for peripheral venous access
- Known hypersensitivity or allergy towards materials used in the adsorber columns
- Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
- Extreme bleeding tendency during anticoagulation
- Hypercoagulability
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 |
|---|---|---|
| immunoadsorptionFirst cycle: week 1, day 1-5 Second cycle: week 5, day 1-5 | Procedure or surgery | 1 |
Primary outcome
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.
Time frame: 13 weeks
1 secondary outcome
Evidence of reduction of concomitant topical and/or systemic medication.
Time frame: 13 weeks
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 28 Jan 2010.
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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.
Detlef Zillikens, M. D. study chair
Department of Dermatology, University of Lübeck, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunoadsorption in people with Dermatitis, Atopic, run by University of Luebeck at 1 site 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 7 inclusion and 13 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 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance. (time frame: 13 weeks). 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 28 Jan 2010.