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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 260
- Primary Endpoint
- Percentage of patients with serum bactericidal antibody titer of ≥ 8
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
tacrolimus ointment 0.03%
Intervention: tacrolimus ointment 0.03% (Drug)
1
tacrolimus ointment 0.03%
Intervention: Meningitec (Biological)
1
tacrolimus ointment 0.03%
Intervention: AC VAX (Biological)
2
hydrocortisone acetate 1% and butyrate 0.1%
Intervention: hydrocortisone acetate ointment 1% (Drug)
2
hydrocortisone acetate 1% and butyrate 0.1%
Intervention: hydrocortisone butyrate ointment 0.1% (Drug)
2
hydrocortisone acetate 1% and butyrate 0.1%
Intervention: Meningitec (Biological)
2
hydrocortisone acetate 1% and butyrate 0.1%
Intervention: AC VAX (Biological)
3
Control group vaccination and challenge dose only
Intervention: Meningitec (Biological)
3
Control group vaccination and challenge dose only
Intervention: AC VAX (Biological)
Outcomes
Primary Outcomes
Percentage of patients with serum bactericidal antibody titer of ≥ 8
Time Frame: 5 weeks
Secondary Outcomes
- Assessment of other immunological parameters(7 months)