Dermatitis, AtopicPhase 3NCT00691262
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
A Phase 3 study testing tacrolimus ointment in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 9 sites in Italy.
Trial summary
Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- tacrolimus ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 9 sitesItaly
- Study dates
- Oct 2003to Feb 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient may be male or female of any ethnic group
- Patient is aged 2 years to 15 years (not having completed his/her 16th birthday) and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5).
- Patient known to be responsive to topical steroids
- Patient's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
- Patient meets the following wash-out criteria:
- Topical corticosteroids
Show all 11Show fewer
- Systemic corticosteroids (for the treatment of AD only)
- Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
- Other investigational drugs
- Light Treatments (UVA, UVB)
- Patient has not taken/patient and legal representative agree that the patient does not take for the complete study period any medication or therapy prohibited by the protocol
Who cannot join
- Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- Patient is pregnant or breast-feeding
- Patient has a skin infection on the affected (and to be treated) area
- Patient has a known hypersensitivity to macrolides in general, to Tacrolimus or any excipient of the ointment
- Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
- Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
- Patient is known to be HIV positive
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites
Study site
Bologna, 40100
Study site
Catania, 95124
Study site
Genova, 16100
Study site
Lecco, 23900
Study site
Naples, 80138
Study site
Padova, 35128
Study site
Roma, 00161
Study site
Roma, 00165
Study site
Roma, 00167
About this study
Official title: A Long Term, Non-comparative, Multi-centre Study to Further Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis.
Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.
Read the detailed description
The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD course.
- Conditions
- Dermatitis, Atopic
- Being tested
- tacrolimus ointment
- Keywords
- Atopic dermatitis, Prograf, Tacrolimus, FK506, Tacrolimus ointment
- 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 ointmentDrug
Also called FK506
transdermal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tacrolimus ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
Measured: 1 year
Secondary outcomes (2)
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if before month 6) visit
Measured: 1 year
The rate of patients with at least 60% improvement in the Score in Atopic Dermatitis (SCORAD) at month 6/end of study (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startOct 2003
- Primary completionFeb 2005
- Study completionFeb 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 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 Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691262
- Sponsor's protocol ID
- FG-506-06-IT-02
- Status last verified
- Aug 2014
- First submitted
- 3 Jun 2008
- 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, Multi-centre Study to Further Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis.
- ClinicalTrials.gov ID
- NCT00691262
- Acronym / sponsor ID
- FG-506-06-IT-02
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic dermatitis, Prograf, Tacrolimus, FK506, Tacrolimus ointment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 5 Jun 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.
Objective of this study is to further assess the response to treatment and safety of 0.03% tacrolimus (FK506) ointment when used for 6 months in pediatric patients with moderate to severe atopic dermatitis, known to be responsive to topical steroids.
Detailed description
The main phase is 6 month duration, but the follow-up phase up to 12 months will allow the collection of RTT and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect AD course.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus ointment |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patient may be male or female of any ethnic group
- Patient is aged 2 years to 15 years (not having completed his/her 16th birthday) and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5).
- Patient known to be responsive to topical steroids
- Patient's legal representative has given written informed consent. If the patient is capable of understanding the purposes and risks of the trial written informed consent has been obtained from the patient as well. Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
- Patient meets the following wash-out criteria:
Key exclusion criteria (7 listed)
- Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- Patient is pregnant or breast-feeding
- Patient has a skin infection on the affected (and to be treated) area
- Patient has a known hypersensitivity to macrolides in general, to Tacrolimus or any excipient of the ointment
- Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
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 ointmentAlso: FK506transdermal | Drug | 1 |
Primary outcome
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit
Time frame: 1 year
2 secondary outcomes
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 12/end of study (if before month 6) visit
Time frame: 1 year
The rate of patients with at least 60% improvement in the Score in Atopic Dermatitis (SCORAD) at month 6/end of study (if before month 6) visit and at month 12/end of study (if after month 6) visit, each compared to baseline (day 1)
Time frame: 1 year
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 director
Astellas Pharma Europe B.V.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus ointment in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 9 sites in Italy.
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 11 inclusion and 7 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 9 sites in Italy. 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?
The rate of patients with at least 50% (i.e. at least moderate) improvement according to the physician's global evaluation of clinical response at month 6/end of study (if before month 6) visit (time frame: 1 year). 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.