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

Astellas

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: hydrocortisone butyrate ointment 0.1%; Biological: AC VAX; Drug: tacrolimus ointment 0.03%; Biological: Meningitec; Drug: hydrocortisone acetate ointment 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00801957

FG-506-06-27

Details and patient eligibility

About

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 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.

Enrollment: 260 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 3 patient groups

1

Experimental group

Description:

tacrolimus ointment 0.03%

Treatment:

Biological: AC VAX

Biological: Meningitec

Drug: tacrolimus ointment 0.03%

2

Active Comparator group

Description:

hydrocortisone acetate 1% and butyrate 0.1%

Treatment:

Biological: AC VAX

Drug: hydrocortisone acetate ointment 1%

Biological: Meningitec

Drug: hydrocortisone butyrate ointment 0.1%

3

Other group

Description:

Control group vaccination and challenge dose only

Treatment:

Biological: AC VAX

Biological: Meningitec