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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00801957 |
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Date of registration:
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03/12/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
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Scientific title:
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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 |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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260 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00801957 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Belgium
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Germany
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Hungary
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Iceland
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Malta
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Poland
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Portugal
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Contacts
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Name:
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Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Astellas Pharma Europe B.V. |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
11 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atopic Dermatitis
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Intervention(s)
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Biological: Meningitec
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Drug: hydrocortisone acetate ointment 1%
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Drug: hydrocortisone butyrate ointment 0.1%
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Drug: tacrolimus ointment 0.03%
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Biological: AC VAX
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Primary Outcome(s)
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Percentage of patients with serum bactericidal antibody titer of = 8
[Time Frame: 5 weeks]
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Secondary Outcome(s)
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Assessment of other immunological parameters
[Time Frame: 7 months]
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Secondary ID(s)
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FG-506-06-27
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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