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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Page 1 of 9 (36 locations)

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