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| Name | Class |
|---|---|
| Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME | INDUSTRY |
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Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nailner 2 in 1 + Ciclopirox 8% | Experimental | Patients should apply Nailner 2 in 1 daily in the affected nail 2X a day, morning and night for 30 days. After 30 days passed to apply only 1x daily. No need to sand the nail before the application and the product should be applied on the entire nail, including the sides and the area affected by ringworm. Avoiding wett the nail after application and expose the nail. They should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. |
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| Ciclopirox 8% | Active Comparator | Patients should also apply ciclopirox 8% nail polish in the first month of treatment every other day (day in and day out). In the second month applied twice a week. In the third month applied once a week. Apply on the affected nails, previously sanded. On the application of two products, Ciclopirox should be applied between the investigational product applications, e.g., in the middle of the day and the investigational product at the beginning and end of the day in the sun. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nailner 2 in 1 | Device | Nailner 2 in 1 is a combination of assets that alter the pH of the nail and is used as an adjunct in the treatment of onychomycosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90 | The improvement rate will be by measuring the area of the nail affected in millimeters (millimeters). The measurement will be taken with a ruler in the direction of the width and length of the lesion (mm2) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination | Through clinical observation | 90 days |
| Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Carolina Prazias Massei | Contact | +55(16)3624-4056 | carolina.prazias@mipbrasilfarma.com.br |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| Ciclopirox 8% | Drug | Ciclopirox 8% is a glaze used in the treatment of onychomycosis |
|
Through the patient's subjective evaluation |
| 45 and 90 days |
| Number of adverse events reported and related to the product investigational | Through the spontaneous report of the patients of events occurred during the study | 90 days |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |