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Completed

NCT Number: NCT00310492

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie

Hanover, D-30449 Hannover, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

subcutaneous immunotherapy

Biological

Updosing by 16 injections to 100,000 SQ-U

Other names: ALK-depot SQ mites

Primary outcomes

  1. Changes from baseline in SCORAD and topical medication consumption

    Time frame: 1 year

    Sccore of atopic dermatitis (SCORAD)

Secondary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 4, 2006
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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