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Trial record 26 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT00801957
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: tacrolimus ointment 0.03% Drug: hydrocortisone acetate ointment 1% Drug: hydrocortisone butyrate ointment 0.1% Biological: Meningitec Biological: AC VAX Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2003
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1
tacrolimus ointment 0.03%
Drug: tacrolimus ointment 0.03%
topical application
Other Name: Protopic 0.03%

Biological: Meningitec
im injection

Biological: AC VAX
im injection

Active Comparator: 2
hydrocortisone acetate 1% and butyrate 0.1%
Drug: hydrocortisone acetate ointment 1%
topical application
Other Name: ATC code H02AB09

Drug: hydrocortisone butyrate ointment 0.1%
topical application
Other Name: ATC code H02AB09

Biological: Meningitec
im injection

Biological: AC VAX
im injection

3
Control group vaccination and challenge dose only
Biological: Meningitec
im injection

Biological: AC VAX
im injection




Primary Outcome Measures :
  1. Percentage of patients with serum bactericidal antibody titer of ≥ 8 [ Time Frame: 5 weeks ]

Secondary Outcome Measures :
  1. Assessment of other immunological parameters [ Time Frame: 7 months ]


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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801957


  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Chair: Central Contact Astellas Pharma Europe B.V.

Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00801957     History of Changes
Other Study ID Numbers: FG-506-06-27
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
atopic dermatitis
meningitis
vaccination
tacrolimus
steroids
equivalence response
meningococcal vaccine
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Hydrocortisone-17-butyrate
Vaccines
Tacrolimus
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents