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

This study has been completed.

Sponsor:

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00801957

First received: December 3, 2008

Last updated: January 21, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 3, 2008

Last Updated Date

January 21, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients with serum bactericidal antibody titer of ≥ 8 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00801957 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of other immunological parameters [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Atopic Dermatitis

Intervention ^ICMJE

Drug: tacrolimus ointment 0.03%
topical application

Other Name: Protopic 0.03%
Drug: hydrocortisone acetate ointment 1%
topical application

Other Name: ATC code H02AB09
Drug: hydrocortisone butyrate ointment 0.1%
topical application

Other Name: ATC code H02AB09
Biological: Meningitec
im injection
Biological: AC VAX
im injection

Study Arm (s)

Experimental: 1
tacrolimus ointment 0.03%
Interventions:
- Drug: tacrolimus ointment 0.03%
- Biological: Meningitec
- Biological: AC VAX
Active Comparator: 2
hydrocortisone acetate 1% and butyrate 0.1%
Interventions:
- Drug: hydrocortisone acetate ointment 1%
- Drug: hydrocortisone butyrate ointment 0.1%
- Biological: Meningitec
- Biological: AC VAX
3
Control group vaccination and challenge dose only
Interventions:
- Biological: Meningitec
- Biological: AC VAX

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

260

Completion Date

November 2004

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years to 11 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Belgium, Germany, Hungary, Iceland, Malta, Poland, Portugal

Administrative Information

NCT Number ^ICMJE

NCT00801957

Other Study ID Numbers ^ICMJE

FG-506-06-27

Has Data Monitoring Committee

Responsible Party

Disclosure Office Europe, Astellas Pharma Europe BV

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Central Contact

Astellas Pharma Europe BV

Information Provided By

Astellas Pharma Inc

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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