Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis
NCT ID: NCT00130364
Last Updated: 2008-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2005-08-31
2006-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Pimecrolimus
Pimecrolimus
Pimecrolimus 1 % cream
2
Pimecrolimus vehicle cream
Placebo
Pimecrolimus vehicle cream (placebo)
Interventions
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Pimecrolimus
Pimecrolimus 1 % cream
Placebo
Pimecrolimus vehicle cream (placebo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients intolerant of, or dependent on, topical corticosteroids
Exclusion Criteria
* Immunocompromised
* Recently received phototherapy or systemic therapy
2 Years
11 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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This study is not being conducted in the United States
Novartis Pharmaceuticals, New Jersey, United States
Countries
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Other Identifiers
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CASM981C2440
Identifier Type: -
Identifier Source: org_study_id
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