Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: tacrolimus ointment 0.03%; Biological: Meningitec; Drug: hydrocortisone acetate ointment 1%; Drug: hydrocortisone butyrate ointment 0.1%; Biological: AC VAX

• Registration Number: NCT00801957
• Lead Sponsor: Astellas Pharma Inc

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 vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2008-12-03
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	tacrolimus ointment 0.03%	tacrolimus ointment 0.03%
3	Meningitec	Control group vaccination and challenge dose only
2	hydrocortisone butyrate ointment 0.1%	hydrocortisone acetate 1% and butyrate 0.1%
1	AC VAX	tacrolimus ointment 0.03%
1	Meningitec	tacrolimus ointment 0.03%
3	AC VAX	Control group vaccination and challenge dose only
2	hydrocortisone acetate ointment 1%	hydrocortisone acetate 1% and butyrate 0.1%
2	Meningitec	hydrocortisone acetate 1% and butyrate 0.1%
2	AC VAX	hydrocortisone acetate 1% and butyrate 0.1%

Primary Outcome Measures

Name	Time	Method
Percentage of patients with serum bactericidal antibody titer of ≥ 8	5 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment of other immunological parameters	7 months