Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
NCT ID: NCT00801957
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2003-03-31
2004-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Moisturizer to Prevent Atopic Dermatitis
NCT03808532
Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis
NCT00691262
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
NCT00480896
Immune Response to Varicella Vaccination in Children With Atopic Dermatitis
NCT00406081
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
NCT02748993
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
tacrolimus ointment 0.03%
tacrolimus ointment 0.03%
topical application
Meningitec
im injection
AC VAX
im injection
2
hydrocortisone acetate 1% and butyrate 0.1%
hydrocortisone acetate ointment 1%
topical application
hydrocortisone butyrate ointment 0.1%
topical application
Meningitec
im injection
AC VAX
im injection
3
Control group vaccination and challenge dose only
Meningitec
im injection
AC VAX
im injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tacrolimus ointment 0.03%
topical application
hydrocortisone acetate ointment 1%
topical application
hydrocortisone butyrate ointment 0.1%
topical application
Meningitec
im injection
AC VAX
im injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C
Exclusion Criteria
* 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
2 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kogarah, New South Wales, Australia
St Leonards, New South Wales, Australia
Benowa, Queensland, Australia
Carina Heights, Queensland, Australia
Herston, Queensland, Australia
North Adelaide, South Australia, Australia
Carlton, Victoria, Australia
Parkville, Victoria, Australia
Fremantle, Western Australia, Australia
Leuven, , Belgium
Bretten, , Germany
Ettenheim, , Germany
Gersfeld, , Germany
Kehl, , Germany
Tettnang, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Kopavogur, , Iceland
Saint Julians, , Malta
Karpacz, , Poland
Krakow, , Poland
Lodz, , Poland
Lodz, , Poland
Opole, , Poland
Poznan, , Poland
Rabka-Zdrój, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Zgierz, , Poland
Lisbon, , Portugal
Porto, , Portugal
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FG-506-06-27
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.