Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
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
1 other identifier
interventional
260
8 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2003
36 active sites
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
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedSeptember 18, 2014
September 1, 2014
1.7 years
December 3, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with serum bactericidal antibody titer of ≥ 8
5 weeks
Secondary Outcomes (1)
Assessment of other immunological parameters
7 months
Study Arms (3)
1
EXPERIMENTALtacrolimus ointment 0.03%
2
ACTIVE COMPARATORhydrocortisone acetate 1% and butyrate 0.1%
3
OTHERControl group vaccination and challenge dose only
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Kogarah, New South Wales, 2217, Australia
Unknown Facility
St Leonards, New South Wales, 2065, Australia
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Benowa, Queensland, 4217, Australia
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Carina Heights, Queensland, 4152, Australia
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Herston, Queensland, 4029, Australia
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North Adelaide, South Australia, 5006, Australia
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Carlton, Victoria, 3053, Australia
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Parkville, Victoria, 3052, Australia
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Fremantle, Western Australia, 6160, Australia
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Leuven, 3000, Belgium
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Bretten, 75015, Germany
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Ettenheim, 77955, Germany
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Gersfeld, 36129, Germany
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Kehl, 77694, Germany
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Tettnang, 88069, Germany
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Budapest, 1089, Hungary
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Debrecen, 4032, Hungary
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Pécs, 7624, Hungary
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Szeged, 6720, Hungary
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Kopavogur, 201, Iceland
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Saint Julians, Malta
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Karpacz, 58-540, Poland
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Krakow, 30-633, Poland
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Lodz, 90-153, Poland
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Lodz, 91-347, Poland
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Opole, 45-372, Poland
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Poznan, 60-214, Poland
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Rabka-Zdrój, 34-700, Poland
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Warsaw, 01-219, Poland
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Warsaw, 04-740, Poland
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Wroclaw, 50-376, Poland
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Wroclaw, 51-136, Poland
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Zabrze, 41-800, Poland
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Zgierz, 95-100, Poland
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Lisbon, 1649-035, Portugal
Unknown Facility
Porto, 4430, Portugal
Related Publications (1)
Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23.
PMID: 16798785BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2008
First Posted
December 4, 2008
Study Start
March 1, 2003
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
September 18, 2014
Record last verified: 2014-09