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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: tacrolimus ointment 0.03%
* Drug: hydrocortisone acetate ointment 1%
* Drug: hydrocortisone butyrate ointment 0.1%
* Biological: Meningitec
* Biological: AC VAX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>tacrolimus ointment 0.03% | Drug: tacrolimus ointment 0.03%<br>* topical application<br>* Other names: Protopic 0.03%;Biological: Meningitec<br>* im injection<br>Biological: AC VAX<br>* im injection<br>|
| Active Comparator: 2<br>hydrocortisone acetate 1% and butyrate 0.1% | Drug: hydrocortisone acetate ointment 1%<br>* topical application<br>* Other names: ATC code H02AB09;Drug: hydrocortisone butyrate ointment 0.1%<br>* topical application<br>* Other names: ATC code H02AB09;Biological: Meningitec<br>* im injection<br>Biological: AC VAX<br>* im injection<br>|
| Other: 3<br>Control group vaccination and challenge dose only | Biological: Meningitec<br>* im injection<br>Biological: AC VAX<br>* im injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with serum bactericidal antibody titer of ≥ 8 |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of other immunological parameters |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine