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To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)
This study is not enrolling patients in the United States.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus Cream 1% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Assessment (IGA) score for the whole body and for the face only. | ||
| Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation. | ||
| Safety assessed by adverse events. |
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The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Healthcare Philippines | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| This study is not being conducted in the United States | Investigative Site | Philippines |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C117268 | pimecrolimus |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |