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

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:

MedlinePlus related topics: Meningitis

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate Tacrolimus

U.S. FDA Resources

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 BV

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 May 19, 2013