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

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Biological: subcutaneous immunotherapy

• Registration Number: NCT00310492
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-02
• Study First Submitted QC: 2006-04-02
• Study First Posted: 2006-04-04
• Primary Completion: 2009-05
• Study Completion: 2009-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous immunotherapy	subcutaneous immunotherapy	Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U
Subcutaneous injections	subcutaneous immunotherapy	placebo injections

Primary Outcome Measures

Name	Time	Method
Changes from baseline in SCORAD and topical medication consumption	1 year	Sccore of atopic dermatitis (SCORAD)

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption	1 year	Eczema Area Severity Index (EASI)

Trial Locations

Locations (1)

Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie; 🇩🇪 Hannover, Germany