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: February 7, 2013
Last verified: February 2013
  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: subcutaneous immunotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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

Primary Outcome Measures:
  • Changes from baseline in SCORAD and topical medication consumption [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sccore of atopic dermatitis (SCORAD)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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)


Enrollment: 154
Study Start Date: April 2006
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00310492     History of Changes
Other Study ID Numbers: SHX0556
Study First Received: April 2, 2006
Last Updated: February 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on July 20, 2014