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NCT00310492 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00310492
Other study ID # SHX0556
Secondary ID
Status Completed
Phase Phase 3
First received April 2, 2006
Last updated December 28, 2015
Start date April 2006
Est. completion date November 2009

Study information
Verified date December 2015
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date November 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• subcutaneous immunotherapy
Updosing by 16 injections to 100,000 SQ-U

Locations
Country Name City State
Germany Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie Hannover

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Other SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI) 1 year No
Primary Changes from baseline in SCORAD and topical medication consumption Sccore of atopic dermatitis (SCORAD) 1 year No
Secondary Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption Eczema Area Severity Index (EASI) 1 year No
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