NCT00310492

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

3.1 years

First QC Date

April 2, 2006

Last Update Submit

December 28, 2015

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline in SCORAD and topical medication consumption

    Sccore of atopic dermatitis (SCORAD)

    1 year

Secondary Outcomes (1)

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

    1 year

Other Outcomes (1)

  • SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire

    1 year

Study Arms (2)

Subcutaneous immunotherapy

ACTIVE COMPARATOR

Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U

Biological: subcutaneous immunotherapy

Subcutaneous injections

PLACEBO COMPARATOR

placebo injections

Biological: subcutaneous immunotherapy

Interventions

subcutaneous immunotherapyBIOLOGICAL

Updosing by 16 injections to 100,000 SQ-U

Also known as: ALK-depot SQ mites
Subcutaneous immunotherapySubcutaneous injections

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive specific IgE to house dust mites
  • Atopic dermatitis according to Hanifin/Rajka
  • Chronic course of Atopic dermatitis
  • SCORAD larger than 25 points

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie

Hanover, D-30449 Hannover, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Hendrik Wolf, PhD

    ALK-SCHERAX Arzneimittel GmbH

    STUDY DIRECTOR

  • Alexander Kapp, MD, Prof.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2006

First Posted

April 4, 2006

Study Start

April 1, 2006

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

DE(1)