Atopic DermatitisPhase 4NCT00130364
Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
A Phase 4 study testing Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in United States.
Trial summary
This study is not being conducted in the United States of America (USA). Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. Read more about this study
- Who is it for?
- Ages 2 to 11 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
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 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 11 years
- All sexes
- Child
Who may be able to join
- Mild to moderate facial atopic dermatitis
- Patients intolerant of, or dependent on, topical corticosteroids
Who cannot join
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
This study is not being conducted in the United States
Novartis Pharmaceuticals, New Jersey
About this study
This study is not being conducted in the United States of America (USA).
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
- Conditions
- Atopic Dermatitis
- Being tested
- Pimecrolimus, Placebo
- Keywords
- Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called Elidel
Pimecrolimus 1 % cream
PlaceboDrug
Pimecrolimus vehicle cream (placebo)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pimecrolimus Receives: Drug: Pimecrolimus |
| 2 | Placebo comparator | Pimecrolimus vehicle cream Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Secondary outcomes (4)
Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Time to clearance of facial IGA (score of 0 or 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startAug 2005
- Study completionAug 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130364
- Sponsor's protocol ID
- CASM981C2440
- Status last verified
- Jan 2008
- First submitted
- 12 Aug 2005
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT00130364
- Acronym / sponsor ID
- CASM981C2440
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, T-cell, pimecrolimus, children, facial, Facial atopic dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Aug 2005 (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 is not being conducted in the United States of America (USA).
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.
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: PlaceboPimecrolimus vehicle cream |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Mild to moderate facial atopic dermatitis
- Patients intolerant of, or dependent on, topical corticosteroids
Key exclusion criteria (3 listed)
- Concurrent skin diseases (infections)
- Immunocompromised
- Recently received phototherapy or systemic therapy
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: ElidelPimecrolimus 1 % cream | Drug | 1 |
| PlaceboPimecrolimus vehicle cream (placebo) | Drug | 2 |
Primary outcome
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
4 secondary outcomes
Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Time to clearance of facial IGA (score of 0 or 1)
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 15 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 Pharmaceuticals study chair
Novartis Pharmaceuticals
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 Pimecrolimus in people with Atopic Dermatitis, run by Novartis at 1 site in United States.
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 3 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 15 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 United States. 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 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?
The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear). 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 15 Jan 2008.