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The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study.
The study duration for each patient was 6 weeks: Following were the visit details.
V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftifine hydrochloride 2% | Experimental | A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
|
| Naftin® 2% (Naftifine hydrochloride 2%) | Active Comparator | A thin layer of sufficient quantity of Naftifine hydrochloride cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
|
| Placebo vehicle cream. | Placebo Comparator | A thin layer of sufficient quantity of vehicle cream need to be applied to the affected areas plus an approximate ½ inch margin of healthy surrounding skin once daily consecutively for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftifine hydrochloride 2% | Drug | Topical application for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mycological cure and clinical cure for a single target lesion for Trichyphyton rubrum | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum. Absence of growth suggests complete cure. | week 6 + 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mycological cure and clinical cure for Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum | After 6 weeks the skin scrapping will be collected for culture to find out the growth of T rubrum, T Mentagrophytes or E floccosum. Absence of growth suggests complete cure. | week 6 + 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of AEs for each treatment groups | number of adverse events reported will be collated from all the treatment arms, to evaluate the safety of the study drugs. | week 6 + 4 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaidoon Al-Zubaidy | Catawba Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moore Clinical Research Inc | Brandon | Florida | 33511 | United States | ||
| Savin Medical Group Research |
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| Placebo | Drug | Topical application for two weeks |
|
|
| Naftin® 2% (Naftifine hydrochloride 2%) | Drug | Topical application for two weeks |
|
|
| Miami |
| Florida |
| 33014 |
| United States |
| International Dermatology Research, Inc, | Miami | Florida | 33144 | United States |
| FXM Research Corp | Miami | Florida | 33175 | United States |
| FXM Research Miramar | Miramar | Florida | 33027 | United States |
| South Tampa, MOORE Clinical Research, Inc. | Tampa | Florida | 33609 | United States |
| North Tampa MOORE Clinical Research, Inc. | Tampa | Florida | 33618 | United States |
| Medi Search | Saint Joseph | Missouri | 64506 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Family Practise | Mesquite | Texas | 75149 | United States |
| Research Across America | Plano | Texas | 75093 | United States |
| Instituto Dermatológico y Cirugía de Piel | Santo Domingo | San Cristóbal | 91000 | Dominican Republic |
| Instituto Dermatológico | Barrio Maria Auxiliadora | Santo Domingo Province | 10305 | Dominican Republic |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C029178 | naftifine |
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