Status:
COMPLETED
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00801957
Start Date
March 1 2003
End Date
November 1 2004
Last Update
September 18 2014
Active Locations (36)
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1
Kogarah, New South Wales, Australia, 2217
2
St Leonards, New South Wales, Australia, 2065
3
Benowa, Queensland, Australia, 4217
4
Carina Heights, Queensland, Australia, 4152