Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis

September 17, 2014 updated by: Astellas Pharma Inc

A Double Blind, Multicentre, Randomised, Parallel Group Study to Demonstrate the Equivalence of the Response to Vaccination of a Tacrolimus Ointment Regimen to a Steroid Ointment Regimen in Children With Moderate to Severe Atopic Dermatitis

Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
      • St. Leonards, New South Wales, Australia, 2065
    • Queensland
      • Benowa, Queensland, Australia, 4217
      • Carina Heights, Queensland, Australia, 4152
      • Herston, Queensland, Australia, 4029
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
    • Victoria
      • Carlton, Victoria, Australia, 3053
      • Parkville, Victoria, Australia, 3052
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
  • Belgium
      • Leuven, Belgium, 3000
  • Germany
      • Bretten, Germany, 75015
      • Ettenheim, Germany, 77955
      • Gersfeld, Germany, 36129
      • Kehl, Germany, 77694
      • Tettnang, Germany, 88069
  • Hungary
      • Budapest, Hungary, 1089
      • Debrecen, Hungary, 4032
      • Pecs, Hungary, 7624
      • Szeged, Hungary, 6720
  • Iceland
      • Kopavogur, Iceland, 201
  • Malta
      • St. Julians, Malta
  • Poland
      • Karpacz, Poland, 58-540
      • Krakow, Poland, 30-633
      • Lodz, Poland, 90-153
      • Lodz, Poland, 91-347
      • Opole, Poland, 45-372
      • Poznan, Poland, 60-214
      • Rabka-Zdroj, Poland, 34-700
      • Warszawa, Poland, 01-219
      • Warszawa, Poland, 04-740
      • Wroclaw, Poland, 50-376
      • Wroclaw, Poland, 51-136
      • Zabrze, Poland, 41-800
      • Zgierz, Poland, 95-100
  • Portugal
      • Lisboa, Portugal, 1649-035
      • Porto, Portugal, 4430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with moderate to severe atopic dermatitis and in need for treatment
  • Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C

Exclusion Criteria:

  • Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine
  • Patients have an acute severe febrile illness, genetic epidermal barrier defect such as Netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area
  • Patients have already received a meningo polysaccharide or conjugated vaccine against meningitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
tacrolimus ointment 0.03%
Drug: tacrolimus ointment 0.03%
topical application
Other Names:
  • Protopic 0.03%
Biological: Meningitec
im injection
Biological: AC VAX
im injection
ACTIVE_COMPARATOR: 2
hydrocortisone acetate 1% and butyrate 0.1%
Biological: Meningitec
im injection
Biological: AC VAX
im injection
Drug: hydrocortisone acetate ointment 1%
topical application
Other Names:
  • ATC code H02AB09
Drug: hydrocortisone butyrate ointment 0.1%
topical application
Other Names:
  • ATC code H02AB09
OTHER: 3
Control group vaccination and challenge dose only
Biological: Meningitec
im injection
Biological: AC VAX
im injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with serum bactericidal antibody titer of ≥ 8
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of other immunological parameters
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

November 1, 2004

Study Completion (ACTUAL)

November 1, 2004

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (ESTIMATE)

December 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-06-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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