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

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

tacrolimus ointment 0.03%

hydrocortisone acetate ointment 1%

hydrocortisone butyrate ointment 0.1%

Meningitec

AC VAX

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Arm Description

tacrolimus ointment 0.03%

hydrocortisone acetate 1% and butyrate 0.1%

Control group vaccination and challenge dose only

Outcomes

Primary Outcome Measures

Percentage of patients with serum bactericidal antibody titer of ≥ 8

Secondary Outcome Measures

Assessment of other immunological parameters

Full Information

NCT ID

NCT00801957

First Posted

December 3, 2008

Last Updated

September 17, 2014

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00801957

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

November 2004 (Actual)

Study Completion Date

November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

tacrolimus ointment 0.03%

Arm Title

Arm Type

Active Comparator

Arm Description

hydrocortisone acetate 1% and butyrate 0.1%

Arm Title

Arm Type

Other

Arm Description

Control group vaccination and challenge dose only

Intervention Type

Drug

Intervention Name(s)

tacrolimus ointment 0.03%

Other Intervention Name(s)

Protopic 0.03%

Intervention Description

topical application

Intervention Type

Drug

Intervention Name(s)

hydrocortisone acetate ointment 1%

Other Intervention Name(s)

ATC code H02AB09

Intervention Description

topical application

Intervention Type

Drug

Intervention Name(s)

hydrocortisone butyrate ointment 0.1%

Other Intervention Name(s)

ATC code H02AB09

Intervention Description

topical application

Intervention Type

Biological

Intervention Name(s)

Meningitec

Intervention Description

im injection

Intervention Type

Biological

Intervention Name(s)

AC VAX

Intervention Description

im injection

Primary Outcome Measure Information:

Title

Percentage of patients with serum bactericidal antibody titer of ≥ 8

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

Assessment of other immunological parameters

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Europe B.V.

Official's Role

Study Chair

Facility Information:

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

City

Benowa

State/Province

Queensland

ZIP/Postal Code

4217

Country

Australia

City

Carina Heights

State/Province

Queensland

ZIP/Postal Code

4152

Country

Australia

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

City

Bretten

ZIP/Postal Code

75015

Country

Germany

City

Ettenheim

ZIP/Postal Code

77955

Country

Germany

City

Gersfeld

ZIP/Postal Code

36129

Country

Germany

City

Kehl

ZIP/Postal Code

77694

Country

Germany

City

Tettnang

ZIP/Postal Code

88069

Country

Germany

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

City

Kopavogur

ZIP/Postal Code

201

Country

Iceland

City

St. Julians

Country

Malta

City

Karpacz

ZIP/Postal Code

58-540

Country

Poland

City

Krakow

ZIP/Postal Code

30-633

Country

Poland

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

City

Lodz

ZIP/Postal Code

91-347

Country

Poland

City

Opole

ZIP/Postal Code

45-372

Country

Poland

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

City

Rabka-Zdroj

ZIP/Postal Code

34-700

Country

Poland

City

Warszawa

ZIP/Postal Code

01-219

Country

Poland

City

Warszawa

ZIP/Postal Code

04-740

Country

Poland

City

Wroclaw

ZIP/Postal Code

50-376

Country

Poland

City

Wroclaw

ZIP/Postal Code

51-136

Country

Poland

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

City

Porto

ZIP/Postal Code

4430

Country

Portugal

12. IPD Sharing Statement

Citations:

PubMed Identifier

16798785

Citation

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.

Results Reference

background

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

Link to Results on JAPIC - enter 140601 in the JapicCTI-RNo. field

Learn more about this trial

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

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