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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310492

Enrollment

154

Registered

2006-04-04

Start date

2006-04-30

Completion date

2009-11-30

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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

Interventions

BIOLOGICALsubcutaneous immunotherapy

Updosing by 16 injections to 100,000 SQ-U

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Changes from baseline in SCORAD and topical medication consumption	1 year	Sccore of atopic dermatitis (SCORAD)

Secondary

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

Other

Measure	Time frame	Description
SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire	1 year	Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026