Dermatitis, AtopicPhase 3NCT00560378
Long-term Safety of Protopic in Atopic Eczema
A Phase 3 study testing Tacrolimus ointment 0.1% in people with Dermatitis, Atopic and Eczema, Atopic, run by Astellas Pharma Inc at 41 sites in 12 countries.
Trial summary
Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1% Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Dermatitis, Atopic, Eczema, Atopic
- What is being tested?
- Tacrolimus ointment 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 789 participants
- Where
- 41 sitesin 12 countries
- Study dates
- Jun 1998to Jun 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
- Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
- Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older
Who cannot join
- Patient has an infection requiring treatment
- Patient is known to be HIV positive
- Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment
Trial locations and contacts
41 sites in 12 countries.
41 sites in 12 countries
France10 sites
Study site
Bordeaux
Study site
Brest
Study site
Gaël
Study site
Lyon
Study site
Nantes
Study site
Paris
Study site
Pessac
Study site
Quimper
Study site
Saint-Etienne
Study site
Tours
Germany9 sites
Study site
Bonn
Study site
Düsseldorf
Study site
Erlangen
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Hanover
Study site
München
Study site
Münster
Study site
Tübingen
United Kingdom8 sites
Study site
Cardiff
Study site
Coventry
Study site
Lancaster
Study site
Leicester
Study site
Liverpool
Study site
London
Study site
Manchester
Study site
Southhampton
About this study
Official title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis
Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%
Read the detailed description
A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).
- Conditions
- Dermatitis, Atopic, Eczema, Atopic
- Being tested
- Tacrolimus ointment 0.1%
- Keywords
- Tacrolimus, Administration, topical, Drug safety, Adults, Children
- 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 0.1%Drug
Also called Protopic
Topical
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus Ointment 0.1% | Experimental | Not described Receives: Drug: Tacrolimus ointment 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 4 Years
Secondary outcomes (1)
Haematology and biochemistry parameters and vital signs
Measured: 4 Years
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 1998
- Study completionJun 2005
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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560378
- Sponsor's protocol ID
- FG-506-06-21
- Status last verified
- Sep 2014
- First submitted
- 16 Nov 2007
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.
PubMed 18637898
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 Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00560378
- Acronym / sponsor ID
- FG-506-06-21
- Conditions
- Dermatitis, Atopic, Eczema, Atopic
- Keywords
- Tacrolimus, Administration, topical, Drug safety, Adults, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 1998
- Study completion
- Jun 2005 (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.
Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%
Detailed description
A long-term, multi-centre, open label, non-comparative phase III study in patients with atopic dermatitis. All centres in Europe which have participated or are still participating in the FG-506-06-12, FG-506-06-18 or FG-506-06-19, FG-506-06-22 or FG-506-06-23 studies will be offered a participation in the protocol. Only patients enrolled by those centres for the above mentioned studies, who have received at least one dose of study medication can be enrolled. Tacrolimus ointment 0.1% will be administered until clearance of the skin occurs. Treatment is restarted after signs and symptoms reoccur. Safety will be assessed from adverse events reported by the patient/parent/guardian or observed by the investigator at the site of application and elsewhere. The safety evaluation will include monitoring of routine hematology and serum chemistry parameters at Baseline/Day 1, Week 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36, Month 42 and/or at the end of the study (End-of-Study Visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus Ointment 0.1% | Experimental | Drug: Tacrolimus ointment 0.1% |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Every patient who has participated in the FG-506-06-12, FG-506-06-18, FG-506-06-19, FG-506-06-22 or FG-506-06-23 study, and has received at least one dose of study medication
- Patient is likely to benefit from further treatment with Tacrolimus (FK506) ointment in the opinion of the investigator
- Patient has atopic dermatitis with Body surface involvement between 5% and 60% for patients with the age of 2 years to 15 years (not having reached their 16th birthday) and between 5% and 100% for patients with 16 years of age or older
Key exclusion criteria (3 listed)
- Patient has an infection requiring treatment
- Patient is known to be HIV positive
- Patient has a systemic disease, including cancer or history of cancer or AIDS, which would contraindicate the use of Tacrolimus (FK506) ointment
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 0.1%Also: ProtopicTopical | Drug | Tacrolimus Ointment 0.1% |
Primary outcome
Incidence of adverse events
Time frame: 4 Years
1 secondary outcome
Haematology and biochemistry parameters and vital signs
Time frame: 4 Years
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 18637898Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.
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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 director
Astellas Pharma GmbH
41 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus ointment 0.1% in people with Dermatitis, Atopic and Eczema, Atopic, run by Astellas Pharma Inc at 41 sites in 12 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 3 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 41 sites in France, Germany, United Kingdom, Finland, Spain and 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of adverse events (time frame: 4 Years). 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 NCT00560378, 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.