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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00801957
Enrollment
260
Registered
2008-12-04
Start date
2003-03-31
Completion date
2004-11-30
Last updated
2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine

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.

Interventions

DRUGtacrolimus ointment 0.03%

topical application

DRUGhydrocortisone acetate ointment 1%

topical application

DRUGhydrocortisone butyrate ointment 0.1%

topical application

BIOLOGICALMeningitec

im injection

BIOLOGICALAC VAX

im injection

Sponsors

Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients with serum bactericidal antibody titer of ≥ 85 weeks

Secondary

MeasureTime frame
Assessment of other immunological parameters7 months

Countries

Australia, Belgium, Germany, Hungary, Iceland, Malta, Poland, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026