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Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00310492
First received: April 2, 2006
Last updated: December 28, 2015
Last verified: December 2015

April 2, 2006
December 28, 2015
April 2006
May 2009   (final data collection date for primary outcome measure)
Changes from baseline in SCORAD and topical medication consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Sccore of atopic dermatitis (SCORAD)
Recording of symptoms and medication
Complete list of historical versions of study NCT00310492 on ClinicalTrials.gov Archive Site
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)
Quality of life and adverse events
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)
Not Provided
 
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
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
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Atopic Dermatitis
Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Name: ALK-depot SQ mites
  • Active Comparator: Subcutaneous immunotherapy
    Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
    Intervention: Biological: subcutaneous immunotherapy
  • Placebo Comparator: Subcutaneous injections
    placebo injections
    Intervention: Biological: subcutaneous immunotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
November 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive specific IgE to house dust mites
  • Atopic dermatitis according to Hanifin/Rajka
  • Chronic course of Atopic dermatitis
  • SCORAD larger than 25 points

Exclusion Criteria:

  • Erythrodermia
  • 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)
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00310492
SHX0556
No
Not Provided
Not Provided
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Study Director: Hendrik Wolf, PhD ALK-SCHERAX Arzneimittel GmbH
Principal Investigator: Alexander Kapp, MD, Prof. Hannover Medical School
ALK-Abelló A/S
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP