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 (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00801957
First received: December 3, 2008
Last updated: September 17, 2014
Last verified: September 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00801957     History of Changes
Other Study ID Numbers: FG-506-06-27
Study First Received: December 3, 2008
Last Updated: September 17, 2014
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
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Tacrolimus
Anti-Inflammatory Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014