Mild to Moderate Atopic DermatitisPhase 4NCT00568412
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis
A Phase 4 study testing Zarzenda and Elidel in people with Mild to Moderate Atopic Dermatitis, run by Bayer at 1 site in Germany.
Trial summary
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- Zarzenda and Elidel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- male and female children and adolescents (aged 2 - 17)
- mild to moderate atopic dermatitis
- patients in whom a treatment with topical corticosteroids in not recommended or possible
- wash out periods to be observed
Who cannot join
- known allergy to one of the two treatments
- known immunodeficiency
- known hepatic or renal insufficiency
- acute skin infections
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik fuer Dermatologie, Universtitaetsklinikum
Bonn, 53105
About this study
Official title: A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
- Conditions
- Mild to Moderate Atopic Dermatitis
- Being tested
- Zarzenda, Elidel
- 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.
ZarzendaDevice
Topical cream, applied twice daily for three weeks
ElidelDrug
1% cream, applied topically twice daily for three weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Zarzenda applied topically twice daily for three weeks Receives: Device: Zarzenda |
| 2 | Active comparator | Elidel 1% cream, applied topically twice daily for three weeks Receives: Drug: Elidel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment
Measured: End of study compared to baseline
Secondary outcomes (4)
EASI
Measured: End of study compared to baseline
Affected body surface area
Measured: End of study compared to baseline
Patient's assessment of itch, quality of sleep, and global assessment
Measured: End of study compared to baseline
Children's Dermatological Life Quality Index
Measured: End of study compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startDec 2007
- 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 Mild to Moderate Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568412
- Sponsor's protocol ID
- 1401920
- Status last verified
- Feb 2015
- First submitted
- 3 Dec 2007
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind Clinical Study to Examine the Efficacy and Safety of Zarzenda in Comparison to Elidel in the Management of Mild to Moderate Atopic Dermatitis in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00568412
- Acronym / sponsor ID
- 1401920
- Conditions
- Mild to Moderate Atopic Dermatitis
- Keywords
- atopic dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Dec 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.
To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: ZarzendaZarzenda applied topically twice daily for three weeks |
| 2 | Active comparator | Drug: ElidelElidel 1% cream, applied topically twice daily for three weeks |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- male and female children and adolescents (aged 2 - 17)
- mild to moderate atopic dermatitis
- patients in whom a treatment with topical corticosteroids in not recommended or possible
- wash out periods to be observed
Key exclusion criteria (4 listed)
- known allergy to one of the two treatments
- known immunodeficiency
- known hepatic or renal insufficiency
- acute skin infections
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 |
|---|---|---|
| ZarzendaTopical cream, applied twice daily for three weeks | Device | 1 |
| Elidel1% cream, applied topically twice daily for three weeks | Drug | 2 |
Primary outcome
Investigator's Global Assessment
Time frame: End of study compared to baseline
4 secondary outcomes
EASI
Time frame: End of study compared to baseline
Affected body surface area
Time frame: End of study compared to baseline
Patient's assessment of itch, quality of sleep, and global assessment
Time frame: End of study compared to baseline
Children's Dermatological Life Quality Index
Time frame: End of study compared to baseline
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 Feb 2015.
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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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zarzenda and Elidel in people with Mild to Moderate Atopic Dermatitis, run by Bayer at 1 site in Germany.
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 4 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 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Investigator's Global Assessment (time frame: End of study compared to baseline). 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 18 Feb 2015.