Atopic DermatitisPhase 2NCT00801957
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
A Phase 2 study testing tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1% and hydrocortisone butyrate ointment 0.1% in people with Atopic Dermatitis, run by Astellas Pharma Inc at 36 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1% and hydrocortisone butyrate ointment 0.1%
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 36 sitesin 8 countries
- Study dates
- Mar 2003to Nov 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
Poland13 sites
Study site
Karpacz, 58-540
Study site
Krakow, 30-633
Study site
Lodz, 90-153
Study site
Lodz, 91-347
Study site
Opole, 45-372
Study site
Poznan, 60-214
Study site
Rabka-Zdrój, 34-700
Study site
Warsaw, 01-219
Study site
Warsaw, 04-740
Study site
Wroclaw, 50-376
Study site
Wroclaw, 51-136
Study site
Zabrze, 41-800
Study site
Zgierz, 95-100
Australia9 sites
Study site
Benowa, Queensland, 4217
Study site
Carina Heights, Queensland, 4152
Study site
Carlton, Victoria, 3053
Study site
Fremantle, Western Australia, 6160
Study site
Herston, Queensland, 4029
Study site
Kogarah, New South Wales, 2217
Study site
North Adelaide, South Australia, 5006
Study site
Parkville, Victoria, 3052
Study site
St Leonards, New South Wales, 2065
Germany5 sites
Study site
Bretten, 75015
Study site
Ettenheim, 77955
Study site
Gersfeld, 36129
Study site
Kehl, 77694
Study site
Tettnang, 88069
Hungary4 sites
Study site
Budapest, 1089
Study site
Debrecen, 4032
Study site
Pécs, 7624
Study site
Szeged, 6720
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1%, hydrocortisone butyrate ointment 0.1%, Meningitec, AC VAX
- Keywords
- atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine
- Medical subject headings
- Dermatitis, Atopic, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus ointment 0.03%Drug
Also called Protopic 0.03%
topical application
hydrocortisone acetate ointment 1%Drug
Also called ATC code H02AB09
topical application
hydrocortisone butyrate ointment 0.1%Drug
Also called ATC code H02AB09
topical application
MeningitecBiological
im injection
AC VAXBiological
im injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | tacrolimus ointment 0.03% Receives: Drug: tacrolimus ointment 0.03%; Biological: Meningitec; Biological: AC VAX |
| 2 | Active comparator | hydrocortisone acetate 1% and butyrate 0.1% Receives: Drug: hydrocortisone acetate ointment 1%; Drug: hydrocortisone butyrate ointment 0.1%; Biological: Meningitec; Biological: AC VAX |
| 3 | Other | Control group vaccination and challenge dose only Receives: Biological: Meningitec; Biological: AC VAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with serum bactericidal antibody titer of ≥ 8
Measured: 5 weeks
Secondary outcomes (1)
Assessment of other immunological parameters
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startMar 2003
- Primary completionNov 2004
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801957
- Sponsor's protocol ID
- FG-506-06-27
- Status last verified
- Sep 2014
- First submitted
- 3 Dec 2008
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16798785
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801957
- Acronym / sponsor ID
- FG-506-06-27
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, meningitis, vaccination, tacrolimus, steroids, equivalence response, meningococcal vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus ointment 0.03%, Biological: Meningitec, Biological: AC VAXtacrolimus ointment 0.03% |
| 2 | Active comparator | Drug: hydrocortisone acetate ointment 1%, Drug: hydrocortisone butyrate ointment 0.1%, Biological: Meningitec, Biological: AC VAXhydrocortisone acetate 1% and butyrate 0.1% |
| 3 | Other | Biological: Meningitec, Biological: AC VAXControl group vaccination and challenge dose only |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimus ointment 0.03%Also: Protopic 0.03%topical application | Drug | 1 |
| hydrocortisone acetate ointment 1%Also: ATC code H02AB09topical application | Drug | 2 |
| hydrocortisone butyrate ointment 0.1%Also: ATC code H02AB09topical application | Drug | 2 |
| Meningitecim injection | Biological | 1, 2, 3 |
| AC VAXim injection | Biological | 1, 2, 3 |
Primary outcome
Percentage of patients with serum bactericidal antibody titer of ≥ 8
Time frame: 5 weeks
1 secondary outcome
Assessment of other immunological parameters
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2014.
- Background: PubMed 16798785Hofman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study chair
Astellas Pharma Europe B.V.
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tacrolimus ointment 0.03%, hydrocortisone acetate ointment 1% and hydrocortisone butyrate ointment 0.1% in people with Atopic Dermatitis, run by Astellas Pharma Inc at 36 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Poland, Australia, Germany, Hungary, Portugal and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with serum bactericidal antibody titer of ≥ 8 (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.