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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: February 7, 2013
Last verified: February 2013
History of Changes
  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
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 May 16, 2013