NCT00801957

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	tacrolimus ointment 0.03%	topical application
DRUG	hydrocortisone acetate ointment 1%	topical application
DRUG	hydrocortisone butyrate ointment 0.1%	topical application
BIOLOGICAL	Meningitec	im injection
BIOLOGICAL	AC VAX	im injection

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2008-12-04
• Last updated: 2014-09-18

Locations

36 sites across 8 countries: Australia, Belgium, Germany, Hungary, Iceland, Malta, Poland, Portugal