Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
This study has been completed.
Sponsor:
ALK-Abelló A/S
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00310492
First received: April 2, 2006
Last updated: February 7, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 2, 2006 | ||||||||
| Last Updated Date | February 7, 2013 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes from baseline in SCORAD and topical medication consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ] Sccore of atopic dermatitis (SCORAD) |
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| Original Primary Outcome Measures ICMJE |
Recording of symptoms and medication | ||||||||
| Change History | Complete list of historical versions of study NCT00310492 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ] Eczema Area Severity Index (EASI) |
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| Original Secondary Outcome Measures ICMJE |
Quality of life and adverse events | ||||||||
| Current Other Outcome Measures ICMJE |
SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ] Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI) |
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| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis | ||||||||
| Official Title ICMJE | Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites | ||||||||
| Brief Summary | This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Atopic Dermatitis | ||||||||
| Intervention ICMJE | Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Name: ALK-depot SQ mites |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 154 | ||||||||
| Completion Date | November 2009 | ||||||||
| Primary Completion Date | May 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00310492 | ||||||||
| Other Study ID Numbers ICMJE | SHX0556 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | ALK-Abelló A/S | ||||||||
| Study Sponsor ICMJE | ALK-Abelló A/S | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | ALK-Abelló A/S | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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