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Lack of subject enrollment over the past two years.
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pimecrolimus | Experimental | Pimecrolimus 1% cream |
|
| 2 | Placebo Comparator | Placebo cream over affected study area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pimecrolimus active cream | Drug | Pimecrolimus 1% cream apply to affected study area twice daily for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis | at baseline, one week and three weeks following treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| modified IGA score | at baseline, one week and three weeks following initiation of therapy | |
| hypopigmentation scale score | baseline, one and three weeks following initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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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| placebo base cream | Other | apply to affected study area twice daily for 21 days |
|
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |