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

Phase 3CompletedNCT00310492

ALK-Abelló A/S154 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

154

Conditions

Atopic Dermatitis

Interventions

subcutaneous immunotherapyBIOLOGICAL

Updosing by 16 injections to 100,000 SQ-U

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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)

Locations (1)

Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie

Hanover, Germany

Outcomes

Primary Outcomes

Changes from baseline in SCORAD and topical medication consumption

Sccore of atopic dermatitis (SCORAD)

Time frame: 1 year

Secondary Outcomes

Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption

Eczema Area Severity Index (EASI)

Time frame: 1 year

Data from ClinicalTrials.gov

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