Moderate/Severe Atopic DermatitisPhase 4NCT01745159
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
A Phase 4 study testing tacrolimus in people with Moderate/Severe Atopic Dermatitis, run by Astellas Pharma China, Inc. at 4 sites in China.
Trial summary
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Moderate/Severe Atopic Dermatitis
- What is being tested?
- tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesChina
- Study dates
- Sep 2012to Nov 2013
- Phase
- Phase 4
- 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
- Diagnosed as AD according to Williams diagnostic criteria.
- Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
- At least approximately 10 % of body area
- Patient is able to reach the centre within 3 days in case of a disease exacerbation.
- Patient's legal representative(s) has/have 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Study site
Beijing
Study site
Chongqing
Study site
Guangzhou
Study site
Shanghai
About this study
Official title: Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
Read the detailed description
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
- Conditions
- Moderate/Severe Atopic Dermatitis
- Being tested
- tacrolimus
- Keywords
- tacrolimus, Protopic, pediatric, atopic dermatitis, China
- Medical subject headings
- Lymphoma, Follicular, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Protopic
| Study group | Role | What they receive |
|---|---|---|
| continued tacrolimus treatment | Experimental | children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period. Receives: Drug: tacrolimus |
| no additional treatment | No intervention | children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first DE (disease exacerbation)
Measured: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
Secondary outcomes (7)
Number of DEs during the DCP
Measured: 6 months of DCP (Disease Control Period)
Eczema Area and Severity Index (EASI)
Measured: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Investigator's Global Assessment (IGA)
Measured: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Duration of DE during DCP
Measured: 6 months of DCP (Disease Control Period)
The overall efficacy during OLP
Measured: After 2 to 6 weeks of OLP (Open Label Period)
Quantity of tacrolimus ointment used
Measured: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Incidence of adverse events
Measured: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate/Severe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745159
- Sponsor's protocol ID
- ACN-PRT-AD-12-1
- Status last verified
- Aug 2014
- First submitted
- 6 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
- ClinicalTrials.gov ID
- NCT01745159
- Acronym / sponsor ID
- ACN-PRT-AD-12-1
- Conditions
- Moderate/Severe Atopic Dermatitis
- Keywords
- tacrolimus, Protopic, pediatric, atopic dermatitis, China
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Dec 2012 (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.
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
Detailed description
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continued tacrolimus treatment | Experimental | Drug: tacrolimuschildren with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period. |
| no additional treatment | No intervention | –children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed as AD according to Williams diagnostic criteria.
- Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
- At least approximately 10 % of body area
- Patient is able to reach the centre within 3 days in case of a disease exacerbation.
- Patient's legal representative(s) has/have 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tacrolimusAlso: Protopic | Drug | continued tacrolimus treatment |
Primary outcome
Time to first DE (disease exacerbation)
Time frame: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
7 secondary outcomes
Number of DEs during the DCP
Time frame: 6 months of DCP (Disease Control Period)
Eczema Area and Severity Index (EASI)
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Investigator's Global Assessment (IGA)
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Duration of DE during DCP
Time frame: 6 months of DCP (Disease Control Period)
The overall efficacy during OLP
Time frame: After 2 to 6 weeks of OLP (Open Label Period)
Quantity of tacrolimus ointment used
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Incidence of adverse events
Time frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
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 5 Aug 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.
Medical Director study director
Astellas Pharma Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus in people with Moderate/Severe Atopic Dermatitis, run by Astellas Pharma China, Inc. at 4 sites in China.
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 5 inclusion and 0 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to first DE (disease exacerbation) (time frame: 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)). 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 5 Aug 2014.