Dermatitis, AtopicPhase 4NCT00673725
Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
A Phase 4 study testing Locobase® REPAIR in people with Dermatitis, Atopic, run by Astellas Pharma Europe B.V. at 3 sites in United Kingdom.
Trial summary
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD Read more about this study
- Who is it for?
- Ages 18 months to 16 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Locobase® REPAIR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Mar 2008to Sep 2008
- 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 18 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has given written informed consent (parents or guardian, child if applicable)
- Moderate to severe AD
- Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1)
- In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period
Who cannot join
- Has infected lesions
- The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
- Current use of Locobase® REPAIR
- Known allergy to Locobase® REPAIR or any of its components
- Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Study site
Liverpool
Study site
Manchester
Study site
Reading
About this study
Official title: A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
- Conditions
- Dermatitis, Atopic
- Being tested
- Locobase® REPAIR
- Keywords
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locobase® REPAIRDrug
emollient
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Locobase® REPAIR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mEASI from baseline to week 3
Measured: 3 Weeks
Secondary outcomes (1)
Physicians Global Evaluation of Clinical Response
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionSep 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673725
- Sponsor's protocol ID
- REP-EC-001
- Other IDs
- EudraCT #: 2006-006462-42
- Status last verified
- Aug 2014
- First submitted
- 6 May 2008
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV,Open Label Study of the Treatment of Children With Moderate to Severe Atopic Dermatitis (AD) Using Locobase® REPAIR as an Adjunctive to Standard Treatment
- ClinicalTrials.gov ID
- NCT00673725
- Acronym / sponsor ID
- REP-EC-001
- Conditions
- Dermatitis, Atopic
- Keywords
- Atopic Dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 7 May 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.
To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
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: Locobase® REPAIR |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Has given written informed consent (parents or guardian, child if applicable)
- Moderate to severe AD
- Continuous use of topical corticosteroid or topical calcineurin inhibitor (TCI) as active treatment of AD for more than 4 weeks prior to screening (no change in topical corticosteroid or TCI is allowed between screening and day 1)
- In the opinion of the investigator, subject is unlikely to require a significant change to his/her current treatment regimen during the study period
Key exclusion criteria (5 listed)
- Has infected lesions
- The last assessment of any clinical study within 3 months prior to the expected date of entering into the study
- Current use of Locobase® REPAIR
- Known allergy to Locobase® REPAIR or any of its components
- Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
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 |
|---|---|---|
| Locobase® REPAIRemollient | Drug | 1 |
Primary outcome
Change in mEASI from baseline to week 3
Time frame: 3 Weeks
1 secondary outcome
Physicians Global Evaluation of Clinical Response
Time frame: 6 Weeks
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 25 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.
Use Central Contact study chair
Astellas Pharma Europe B.V.
3 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 Locobase® REPAIR in people with Dermatitis, Atopic, run by Astellas Pharma Europe B.V. at 3 sites in United Kingdom.
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 4 inclusion and 5 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 25 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 3 sites in 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 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?
Change in mEASI from baseline to week 3 (time frame: 3 Weeks). 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 25 Aug 2014.