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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00801957
First received: December 3, 2008
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: tacrolimus ointment 0.03%
Drug: hydrocortisone acetate ointment 1%
Drug: hydrocortisone butyrate ointment 0.1%
Biological: Meningitec
Biological: AC VAX
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Percentage of patients with serum bactericidal antibody titer of ≥ 8 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of other immunological parameters [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Enrollment: 260
Study Start Date: March 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
tacrolimus ointment 0.03%
Drug: tacrolimus ointment 0.03%
topical application
Other Name: Protopic 0.03%
Biological: Meningitec
im injection
Biological: AC VAX
im injection
Active Comparator: 2
hydrocortisone acetate 1% and butyrate 0.1%
Drug: hydrocortisone acetate ointment 1%
topical application
Other Name: ATC code H02AB09
Drug: hydrocortisone butyrate ointment 0.1%
topical application
Other Name: ATC code H02AB09
Biological: Meningitec
im injection
Biological: AC VAX
im injection
3
Control group vaccination and challenge dose only
Biological: Meningitec
im injection
Biological: AC VAX
im injection

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.

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801957

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00801957     History of Changes
Other Study ID Numbers: FG-506-06-27
Study First Received: December 3, 2008
Last Updated: January 21, 2009
Health Authority: Australia: Human Research Ethics Committee
Belgium: Ministry of Social Affairs, Public Health and the Environment
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute

Keywords provided by Astellas Pharma Inc:
atopic dermatitis
meningitis
vaccination
tacrolimus
steroids
equivalence response
meningococcal vaccine

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014