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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2004

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.

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

Arms, Groups and Cohorts

  • Experimental: 1
    • tacrolimus ointment 0.03%
  • Active Comparator: 2
    • hydrocortisone acetate 1% and butyrate 0.1%
  • Other: 3
    • Control group vaccination and challenge dose only

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients with serum bactericidal antibody titer of ≥ 8
    • Time Frame: 5 weeks

Secondary Measures

  • Assessment of other immunological parameters
    • Time Frame: 7 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Astellas Pharma Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Central Contact, Study Chair, Astellas Pharma Europe B.V.

References

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. doi: 10.1136/adc.2006.094276. Epub 2006 Jun 23. Erratum In: Arch Dis Child. 2007 Jan;92(1):93.

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