Atopic DermatitisPhase 4NCT00925730
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
A Phase 4 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 2 sites in Germany.
Trial summary
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema. 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- Mar 2004to Jan 2006
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients 2 - 18 years of age
- Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.
Who cannot join
- Erythrodermic patients with Netherton's syndrome
- Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
- Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novartis Investigative Site
Bonn
Novartis Investigative Site
Frankfurt am Main
About this study
Official title: Non-comparative Open-label Study to Investigate the Efficacy, Safety and Systemic Exposure of Pimecrolimus in Adult and Pediatric Patients With Moderate to Severe Atopic Dermatitis Treated Topically for 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus
- Keywords
- Atopic dermatitis, AD, pimecrolimus, blood, absorption, systemic
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus cream 1% | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pimecrolimus blood concentration
Measured: Days 1, 9, 16
Secondary outcomes (1)
Efficacy as assessed by the Eczema Area and Severity Index and the Investigators Global Assessment of disease severity. Efficacy outcomes were of an exploratory nature in this study.
Measured: Days 1, 9, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startMar 2004
- Primary completionJan 2006
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925730
- Sponsor's protocol ID
- CASM981C2313
- Status last verified
- Nov 2016
- First submitted
- 17 Jun 2009
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Thaci D, Kaufmann R, Bieber T, Hanfland J, Hauffe S, Koehne-Voss S, Waldmeier F. Percutaneous absorption of pimecrolimus is not increased in patients with moderate to severe atopic dermatitis when pimecrolimus cream 1% is applied under occlusion. Dermatology. 2010;221(4):342-51. doi: 10.1159/000320125. Epub 2010 Nov 22.
PubMed 21099191
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-comparative Open-label Study to Investigate the Efficacy, Safety and Systemic Exposure of Pimecrolimus in Adult and Pediatric Patients With Moderate to Severe Atopic Dermatitis Treated Topically for 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
- ClinicalTrials.gov ID
- NCT00925730
- Acronym / sponsor ID
- CASM981C2313
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, AD, pimecrolimus, blood, absorption, systemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Jan 2006 (actual)
- First posted
- 22 Jun 2009 (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 access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e. areas treated wrapped in a plastic film) over 8 days in patients with moderate to severe atopic eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus cream 1% | Experimental | Drug: PimecrolimusPimecrolimus |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients 2 - 18 years of age
- Patients with a diagnosis of moderate to severe atopic dermatitis, assessed by a score ≥ 3 at the Investigator's Global Assessment. AD to involve at least 30% of their body surface area as determined by the rule of nine or the Lund and Browder chart.
Key exclusion criteria (4 listed)
- Erythrodermic patients with Netherton's syndrome
- Patients with known serious adverse reactions or hypersensitivity to any of the excipients of the study medication
- Patients with a history of cancer, skin malignancy or lymphoproliferative disorders or of immunocompromise, including a positive HIV (ELISA and Western blot), Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Pimecrolimus | Drug | Pimecrolimus cream 1% |
Primary outcome
Pimecrolimus blood concentration
Time frame: Days 1, 9, 16
1 secondary outcome
Efficacy as assessed by the Eczema Area and Severity Index and the Investigators Global Assessment of disease severity. Efficacy outcomes were of an exploratory nature in this study.
Time frame: Days 1, 9, 16
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 Nov 2016.
- Results publication: PubMed 21099191Thaci D, Kaufmann R, Bieber T, Hanfland J, Hauffe S, Koehne-Voss S, Waldmeier F. Percutaneous absorption of pimecrolimus is not increased in patients with moderate to severe atopic dermatitis when pimecrolimus cream 1% is applied under occlusion. Dermatology. 2010;221(4):342-51. doi: 10.1159/000320125. Epub 2010 Nov 22.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
2 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 Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 2 sites 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 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pimecrolimus blood concentration (time frame: Days 1, 9, 16). 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 NCT00925730, 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 Nov 2016.