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This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old.
Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and tolerability of Dapaconazole cream 2% after multiple administrations.
Participants will receive either new intervention or active control during 14 consecutive days, which will be followed by 2 follow-up visits.
Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapaconazole | Experimental | Dapaconazole 2% Cream Topical |
|
| Ketoconazole | Active Comparator | Ketoconazole 2% Cream Topical |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapaconazole | Drug |
|
| |
| Ketoconazole |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure of the lesion | Assessment of presence or absence of the lesion by clinical examination | 14 days |
| Mycological cure of the lesion | Laboratory test for presence or absence of Tinea pedis | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) until clinical diagnosis of lesion cure | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of adverse events | 45 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilberto De Nucci, PhD | Galeno Desenvolvimento de Pesquisas Ltda. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Gobbato de Dermatologia | Rio Claro | São Paulo | 13501-110 | Brazil |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000593721 | 1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazole |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| 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 |