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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801957
• Other study ID #: FG-506-06-27
• Status: Completed
• Phase: Phase 2
• First received: December 3, 2008
• Last updated: September 17, 2014
• Start date: March 2003
• Est. completion date: November 2004

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeBelgium: Ministry of Social Affairs, Public Health and the EnvironmentGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• tacrolimus ointment 0.03%
topical application
• hydrocortisone acetate ointment 1%
topical application
• hydrocortisone butyrate ointment 0.1%
topical application

Biological:
• Meningitec
im injection
• AC VAX
im injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

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

References & Publications (1)

Hofman T, Cranswick N, Kuna P, Boznanski A, Latos T, Gold M, Murrell DF, Gebauer K, Behre U, Machura E, Olafsson J, Szalai Z; International Tacrolimus Ointment Study Group. Tacrolimus ointment does not affect the immediate response to vaccination, the generation of immune memory, or humoral and cell-mediated immunity in children. Arch Dis Child. 2006 Nov;91(11):905-10. Epub 2006 Jun 23. Erratum in: Arch Dis Child. 2007 Jan;92(1):93. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with serum bactericidal antibody titer of = 8		5 weeks	No
Secondary	Assessment of other immunological parameters		7 months	No

External Links

•   Link to Results on JAPIC - enter 140601 in the JapicCTI-RNo. field