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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310492
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief Summary:
This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: subcutaneous immunotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2006
Primary Completion Date : May 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Subcutaneous immunotherapy
Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Name: ALK-depot SQ mites
Placebo Comparator: Subcutaneous injections
placebo injections
Biological: subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U
Other Name: ALK-depot SQ mites



Primary Outcome Measures :
  1. Changes from baseline in SCORAD and topical medication consumption [ Time Frame: 1 year ]
    Sccore of atopic dermatitis (SCORAD)


Secondary Outcome Measures :
  1. Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption [ Time Frame: 1 year ]
    Eczema Area Severity Index (EASI)


Other Outcome Measures:
  1. SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire [ Time Frame: 1 year ]
    Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310492


Locations
Germany
Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie
Hannover, Germany, D-30449 Hannover
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Study Director: Hendrik Wolf, PhD ALK-SCHERAX Arzneimittel GmbH
Principal Investigator: Alexander Kapp, MD, Prof. Hannover Medical School

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00310492     History of Changes
Other Study ID Numbers: SHX0556
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases