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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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%
Treatment: Other - Meningitec
Treatment: Other - 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

Treatment: Other: Meningitec
im injection

Treatment: Other: AC VAX
im injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
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
Sex
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
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2004
Sample size
Target
Accrual to date
Final
260
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/study/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. doi: 10.1136/adc.2006.094276. 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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00801957