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The purpose of this study is to evaluate the safety and efficacy of fluconazole for the treatment of tinea capitis in pediatric patients aged 3 to 12 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluconazole | Drug | Fluconazole oral suspension 6 mg/kg/day for 6 weeks followed by 4 weeks without treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined clinical and mycological outcome at Week 6 | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome based on signs and symptoms at Weeks 3, 6, and 10 | Weeks 3, 6, and 10 | |
| Combined clinical and mycological outcome at Weeks 3 and 10 | Weeks 3 and 10 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Montgomery | Alabama | 36116 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Mycological outcome based on culture results at Weeks 3, 6, and 10 |
| Weeks 3, 6, and 10 |
| Culture results at Weeks 3, 6, and 10 | Weeks 3, 6, and 10 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | Miami | Florida | 33156-7712 | United States |
| Pfizer Investigational Site | Miami | Florida | 33156 | United States |
| Pfizer Investigational Site | Martinez | Georgia | 30907 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60630 | United States |
| Pfizer Investigational Site | Evanston | Illinois | 60202 | United States |
| Pfizer Investigational Site | Gretna | Louisiana | 70056 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70119 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71105 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48201 | United States |
| Pfizer Investigational Site | Fridley | Minnesota | 55432 | United States |
| Pfizer Investigational Site | Bridgeton | Missouri | 63044 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11203-2098 | United States |
| Pfizer Investigational Site | Garner | North Carolina | 27529 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27609 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43205 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37927 | United States |
| Pfizer Investigational Site | Murfreesboro | Tennessee | 37130 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37215 | United States |
| Pfizer Investigational Site | Houston | Texas | 77056 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78205 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78224 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Norfolk | Virginia | 23507 | United States |
| Pfizer Investigational Site | Carolina | 00985 | Puerto Rico |
| Pfizer Investigational Site | Ponce | 00717-2115 | Puerto Rico |
| Pfizer Investigational Site | Ponce | 99717 | Puerto Rico |
| ID | Term |
|---|---|
| D014006 | Tinea Capitis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012536 | Scalp Dermatoses |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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