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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00801957




Registration number
NCT00801957
Ethics application status
Date submitted
3/12/2008
Date registered
4/12/2008
Date last updated
18/09/2014

Titles & IDs
Public title
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
FG-506-06-27
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tacrolimus ointment 0.03%
Treatment: Drugs - hydrocortisone acetate ointment 1%
Treatment: Drugs - hydrocortisone butyrate ointment 0.1%
Other interventions - Meningitec
Other interventions - AC VAX

Experimental: 1 - tacrolimus ointment 0.03%

Active Comparator: 2 - hydrocortisone acetate 1% and butyrate 0.1%

Other: 3 - Control group vaccination and challenge dose only


Treatment: Drugs: tacrolimus ointment 0.03%
topical application

Treatment: Drugs: hydrocortisone acetate ointment 1%
topical application

Treatment: Drugs: hydrocortisone butyrate ointment 0.1%
topical application

Other interventions: Meningitec
im injection

Other interventions: AC VAX
im injection

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with serum bactericidal antibody titer of = 8
Timepoint [1] 0 0
5 weeks
Secondary outcome [1] 0 0
Assessment of other immunological parameters
Timepoint [1] 0 0
7 months

Eligibility
Key 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
Minimum age
2 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Kogarah
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- Benowa
Recruitment hospital [4] 0 0
- Carina Heights
Recruitment hospital [5] 0 0
- Herston
Recruitment hospital [6] 0 0
- North Adelaide
Recruitment hospital [7] 0 0
- Carlton
Recruitment hospital [8] 0 0
- Parkville
Recruitment hospital [9] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4217 - Benowa
Recruitment postcode(s) [4] 0 0
4152 - Carina Heights
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5006 - North Adelaide
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Germany
State/province [2] 0 0
Bretten
Country [3] 0 0
Germany
State/province [3] 0 0
Ettenheim
Country [4] 0 0
Germany
State/province [4] 0 0
Gersfeld
Country [5] 0 0
Germany
State/province [5] 0 0
Kehl
Country [6] 0 0
Germany
State/province [6] 0 0
Tettnang
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Hungary
State/province [8] 0 0
Debrecen
Country [9] 0 0
Hungary
State/province [9] 0 0
Pecs
Country [10] 0 0
Hungary
State/province [10] 0 0
Szeged
Country [11] 0 0
Iceland
State/province [11] 0 0
Kopavogur
Country [12] 0 0
Malta
State/province [12] 0 0
St. Julians
Country [13] 0 0
Poland
State/province [13] 0 0
Karpacz
Country [14] 0 0
Poland
State/province [14] 0 0
Krakow
Country [15] 0 0
Poland
State/province [15] 0 0
Lodz
Country [16] 0 0
Poland
State/province [16] 0 0
Opole
Country [17] 0 0
Poland
State/province [17] 0 0
Poznan
Country [18] 0 0
Poland
State/province [18] 0 0
Rabka-Zdroj
Country [19] 0 0
Poland
State/province [19] 0 0
Warszawa
Country [20] 0 0
Poland
State/province [20] 0 0
Wroclaw
Country [21] 0 0
Poland
State/province [21] 0 0
Zabrze
Country [22] 0 0
Poland
State/province [22] 0 0
Zgierz
Country [23] 0 0
Portugal
State/province [23] 0 0
Lisboa
Country [24] 0 0
Portugal
State/province [24] 0 0
Porto

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00801957
Trial related presentations / publications
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. Epub 2006 Jun 23. Erratum in: Arch Dis Child. 2007 Jan;92(1):93.
Public notes

Contacts
Principal investigator
Name 0 0
Central Contact
Address 0 0
Astellas Pharma Europe B.V.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications