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

NCT00801957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-09-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2004-11-30
Completion
2004-11-30

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00801957 on ClinicalTrials.gov