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This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftin® Cream, 2% (younger pediatric cohort) | Experimental | Subject aged 2 years to 5 years, 11 months with tinea corporis |
|
| Naftin® Cream, 2% (older pediatric cohort) | Experimental | Subject aged 6 years to 11 years, 11 months with tinea corporis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftin® Cream, 2% (younger pediatric cohort) | Drug | Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis | AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate plasma PK single and multiple dose PK variables | tmax and tmax,ss | 2 weeks |
| Evaluate trough plasma PK concentration | Ctrough, ttrough,max, Ctrough,max |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan B. Fleischer, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigative Site#001261 | College Station | Texas | 77845 | United States | ||
| Merz Investigative Site#180001 |
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| ID | Term |
|---|---|
| D014005 | Tinea |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Naftin® Cream, 2% (older pediatric cohort) | Drug | Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months. |
|
| 2 weeks |
| Evaluate urine PK single and multiple dose variables | Ae0-24, fe, CLR, AEt,ss | 2 weeks |
| Santo Domingo |
| Dominican Republic |
| Merz Investigative Site #504001 | San Pedro Sula | Honduras |
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |