Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
NCT ID: NCT00310492
Last Updated: 2015-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2006-04-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Subcutaneous immunotherapy
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Subcutaneous injections
placebo injections
subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Interventions
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subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Atopic dermatitis according to Hanifin/Rajka
* Chronic course of Atopic dermatitis
* SCORAD larger than 25 points
Exclusion Criteria
* Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks
* History of specific immunotherapy with mites
* UV radiation
* Group 4 topical corticosteroids (European classification)
18 Years
55 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Hendrik Wolf, PhD
Role: STUDY_DIRECTOR
ALK-SCHERAX Arzneimittel GmbH
Alexander Kapp, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
Hanover, , Germany
Countries
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Other Identifiers
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SHX0556
Identifier Type: -
Identifier Source: org_study_id