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| Name | Class |
|---|---|
| Laboratório Saúde Ltda - principal e único patrocinador | UNKNOWN |
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This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. 100% of the sample shall be subjected to clinical evaluation through comb, pre and post treatment and monitored after thirty days for evaluation of safety and possible adverse effects that may arise related to any of the components of the formula.
The efficacy study is active comparator, non-inferiority.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIOLIN® | Experimental | PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN |
|
| NEDAX | Active Comparator | FOLLOWING THE LEAFLET TREATMENT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIOLIN® | Drug | PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN |
|
| Measure | Description | Time Frame |
|---|---|---|
| EFFICACY | AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically | 17 DAYS |
| Measure | Description | Time Frame |
|---|---|---|
| SAFETY | IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams | 30 DAYS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KARLA F DEUD JOSÉ, PharmD PhD | Contact | 55 51 9279-3075 | karla@phytopharm.com.br | |
| Karla F Deud José, PharmD PhD | Contact | 55 51 3231-7876 | karladeud@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MONICA M MENDES, MD MSc | UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS | Principal Investigator |
| ACHILLES GENTILINI NETO, MD | INDEPENDENT | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ubs Fatima | Pelotas | Rio Grande do Sul | 96075-540 | Brazil |
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| Label | URL |
|---|---|
| Brazilian researchers and professors site | View source |
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| ID | Term |
|---|---|
| D010373 | Lice Infestations |
| ID | Term |
|---|---|
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| NEDAX | Drug | AS SPECIFIED AT THE LEAFLET |
|
|
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |