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| Name | Class |
|---|---|
| Clinical Research Computing Unit (University of Pennsylvania) | OTHER |
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This study will examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
Registry study to examine the risk of systemic malignancies in pediatric patients with atopic dermatitis exposed to Elidel 1% cream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Single-group Open Label Registry of patients exposed to Elidel/Pimecrolimus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus | Drug | Pimecrolimus 1% cream |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of systemic malignancies in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream | 10 years of observation with 6-month reporting intervals |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence rate of lymphoma in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream | 10 years of observation with 6-month reporting intervals | |
| The incidence rate of thyroid cancer in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream |
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Inclusion Criteria:
Exclusion Criteria:
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Children (ages 2-17 years)
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| Name | Affiliation | Role |
|---|---|---|
| Varsha Bhatt | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Registry | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| 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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| 10 years of observation with 6-month reporting intervals |
| The incidence rate of cutaneous malignancy in pediatric subjects with atopic dermatitis who have been exposed to pimecrolimus 1% cream | 10 years of observation with 6-month reporting intervals |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |