Dermatitis, AtopicPhase 2NCT00560326
Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis
A Phase 2 study testing Tacrolimus Ointment 0.03% in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 8 sites in 5 countries.
Trial summary
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 6 to 30 months
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Tacrolimus Ointment 0.03%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jun 2003to Dec 2006
- 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 6 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
- Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.
Who cannot join
- Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
- Patient has clinically infected atopic dermatitis.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
About this study
Official title: A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
Read the detailed description
This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.
During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.
Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.
Height, weight and pulse of the patient are recorded at each visit.
Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.
- Conditions
- Dermatitis, Atopic
- Being tested
- Tacrolimus Ointment 0.03%
- Keywords
- Paediatric patients, Tacrolimus, Dermatitis, Atopic
- Medical subject headings
- Dermatitis, Atopic
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%
Once or twice daily topical application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Tacrolimus Ointment 0.03% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
Measured: 24 months
Secondary outcomes (1)
Assess efficacy from parameters as follows: - Physician's global evaluation of clinical response - Physician's assessment of individual signs - Affected area - Parent/guardian's assessment of global response - EASI
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startJun 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00560326
- Sponsor's protocol ID
- FG-506-06-33
- Status last verified
- Aug 2014
- First submitted
- 16 Nov 2007
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Non-comparative Study to Evaluate the Safety and Efficacy of Tacrolimus Oint¬Ment in Paediatric Patients
- ClinicalTrials.gov ID
- NCT00560326
- Acronym / sponsor ID
- FG-506-06-33
- Conditions
- Dermatitis, Atopic
- Keywords
- Paediatric patients, Tacrolimus, Dermatitis, Atopic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Nov 2007 (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.
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
Detailed description
This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.
During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.
Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.
Height, weight and pulse of the patient are recorded at each visit.
Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tacrolimus Ointment 0.03% |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
- Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.
Key exclusion criteria (2 listed)
- Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
- Patient has clinically infected atopic dermatitis.
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%Once or twice daily topical application | Drug | 1 |
Primary outcome
Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations
Time frame: 24 months
1 secondary outcome
Assess efficacy from parameters as follows: - Physician's global evaluation of clinical response - Physician's assessment of individual signs - Affected area - Parent/guardian's assessment of global response - EASI
Time frame: 24 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 1 Sep 2014.
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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.
8 sites in 5 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% in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 8 sites in 5 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 2 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 1 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 8 sites in Canada, Ireland, Finland, Latvia, United Kingdom. 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?
Assess safety from observations of adverse events, laboratory examinations, pulse, height, weight and tacrolimus blood concentrations (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2014.