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Efficacy and Safety Trial of ALK-Depot SQ Mites in Subjects With Atopic Dermatitis
This study is ongoing, but not recruiting participants.
Sponsored by: ALK-Abelló A/S
Information provided by: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00310492
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
 Biological: ALK-depot SQ mites
 Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Recording of symptoms and medication

Secondary Outcome Measures:
  • Quality of life and adverse events

Estimated Enrollment: 140
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Study ID Numbers: SHX0556
Study First Received: April 2, 2006
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00310492  
Health Authority: Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
 Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009



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