Dermatitis, AtopicPhase 3NCT00480896
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
A Phase 3 study testing tacrolimus ointment in people with Dermatitis, Atopic, run by Astellas Pharma Inc at 22 sites in 11 countries.
Trial summary
A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares. 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?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 22 sitesin 11 countries
- Study dates
- Jun 2004to Nov 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
- Male or female patient of any ethnic group
- Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)
Who cannot join
- Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- Patient had a clinically significant skin infection on the affected (and to be treated) area
Trial locations and contacts
22 sites in 11 countries.
22 sites in 11 countries
Germany4 sites
Study site
Düsseldorf
Study site
Frankfurt
Study site
Kiel
Study site
Mahlow
Netherlands4 sites
Study site
Amsterdam
Study site
Groningen
Study site
Nijmegen
Study site
Utrecht
About this study
Official title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"
A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.
- Conditions
- Dermatitis, Atopic
- Being tested
- tacrolimus ointment, Placebo ointment
- Keywords
- Dermatitis, atopic, Tacrolimus, Child, treatment outcomes
- 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 Protopic®, FK506 ointment
Topical application
Placebo ointmentDrug
Topical application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tacrolimus ointment |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations of atopic dermatitis requiring intervention.
Measured: 12 months
Secondary outcomes (1)
Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJun 2004
- Primary completionNov 2005
- Study completionNov 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Principal investigator, Universitätsklinikum Frankfurt Zentrum für Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480896
- Sponsor's protocol ID
- FG-506-06-41
- Status last verified
- Sep 2014
- First submitted
- 30 May 2007
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thaci D, Reitamo S, Gonzalez Ensenat MA, Moss C, Boccaletti V, Cainelli T, van der Valk P, Buckova H, Sebastian M, Schuttelaar ML, Ruzicka T; European Tacrolimus Ointment Study Group. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol. 2008 Dec;159(6):1348-56. doi: 10.1111/j.1365-2133.2008.08813.x. Epub 2008 Sep 6.
PubMed 18782319
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
- Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"
- ClinicalTrials.gov ID
- NCT00480896
- Acronym / sponsor ID
- FG-506-06-41
- Conditions
- Dermatitis, Atopic
- Keywords
- Dermatitis, atopic, Tacrolimus, Child, treatment outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 31 May 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.
A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus ointment |
| 2 | Placebo comparator | Drug: Placebo ointment |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female patient of any ethnic group
- Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)
Key exclusion criteria (2 listed)
- Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
- Patient had a clinically significant skin infection on the affected (and to be treated) area
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: Protopic®, FK506 ointmentTopical application | Drug | 1 |
| Placebo ointmentTopical application | Drug | 2 |
Primary outcome
Number of exacerbations of atopic dermatitis requiring intervention.
Time frame: 12 months
1 secondary outcome
Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response.
Time frame: 12 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 18782319Thaci D, Reitamo S, Gonzalez Ensenat MA, Moss C, Boccaletti V, Cainelli T, van der Valk P, Buckova H, Sebastian M, Schuttelaar ML, Ruzicka T; European Tacrolimus Ointment Study Group. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol. 2008 Dec;159(6):1348-56. doi: 10.1111/j.1365-2133.2008.08813.x. Epub 2008 Sep 6.
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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.
Use Central Contact principal investigator
Universitätsklinikum Frankfurt Zentrum für Dermatologie
22 sites in 11 countries: 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 22 sites in 11 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 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 22 sites in Germany, Netherlands, Italy, Czechia, France and 6 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. Some participants in this study may receive a placebo. 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?
Number of exacerbations of atopic dermatitis requiring intervention. (time frame: 12 months). 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 NCT00480896, 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.