Atopic DermatitisPhase 3NCT00351052
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis
A Phase 3 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in Germany.
Trial summary
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Pimecrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2001to Sep 2004
- 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 18 years
- All sexes
- Child, Adult
Who may be able to join
- Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
- responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase
Who cannot join
- Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus, Placebo
- Keywords
- Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel
Pimecroliums cream 1 % bid.
PlaceboDrug
Vehicle control (placebo) bid.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
| 2 | Placebo comparator | Vehicle Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticoid-sparing effect of pimecrolimus cream 1%
Secondary outcomes (3)
atopic dermatitis control
safety of pimecrolimus cream 1%
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startDec 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis AG, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351052
- Sponsor's protocol ID
- CASM981CDE10
- Status last verified
- Jan 2008
- First submitted
- 10 Jul 2006
- Last updated
- 17 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Randomized, Multicenter, Parallel-Group, Double-Blind, Vehicle-Controlled Study on Pimecrolimus Cream 1% Assessing the Steroid-Sparing Effect in the Long Term Management of Pediatric Patients With Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00351052
- Acronym / sponsor ID
- CASM981CDE10
- Conditions
- Atopic Dermatitis
- Keywords
- Pimecrolimus, Atopic Dermatitis, Eczema, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Sep 2004 (actual)
- First posted
- 12 Jul 2006 (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.
This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric 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 | Experimental | Drug: PimecrolimusPimecrolimus |
| 2 | Placebo comparator | Drug: PlaceboVehicle |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Outpatients aged 2 to < 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
- responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase
Key exclusion criteria (1 listed)
- Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to 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 |
|---|---|---|
| PimecrolimusAlso: ElidelPimecroliums cream 1 % bid. | Drug | 1 |
| PlaceboVehicle control (placebo) bid. | Drug | 2 |
Primary outcome
Corticoid-sparing effect of pimecrolimus cream 1%
3 secondary outcomes
atopic dermatitis control
safety of pimecrolimus cream 1%
quality of life
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 17 Jan 2008.
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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.
Novartis AG study chair
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis 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 2 inclusion and 1 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 17 Jan 2008. 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. 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?
Corticoid-sparing effect of pimecrolimus cream 1%. 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 17 Jan 2008.