Efficacy and Safety Study for PIOLIN® Shampoo

Study Overview
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Brief Summary
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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.

Official Title
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Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis

Conditions
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PEDICULOSIS

Intervention / Treatment
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* Drug: PIOLIN®
* Drug: NEDAX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers healthy female and male ; Children between 2 and 17 years ; Increased from 18 years; Availability of volunteer to maintain a stable weight during the study period (ranging from less than 2 kg) ; Displays lice infestation on clinical examination ; Voluntary participation ; Signing the consent form and / or Free and Informed Consent ; Willingness to comply with study procedures ; Complying that researchers can make use of all the information nameless , including publication and comply with the use and storage of all information confidential . Exclusion Criteria: Use paint or other chemicals on the hair in the last four weeks that precede the study ; Concomitant Therapy ; Women who are pregnant or intend to become pregnant during the study ; Infants ; Volunteers not willing to sign and adhere to the Statement of Consent ; Known hypersensitivity to the product ; Participation in any other clinical study ; Any other condition that the investigator decides that might interfere with the results or involving a risk to the volunteer study

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PIOLIN®<br>PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN | Drug: PIOLIN®<br>* PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN<br>* Other names: RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT;|
| Active Comparator: NEDAX<br>FOLLOWING THE LEAFLET TREATMENT | Drug: NEDAX<br>* AS SPECIFIED AT THE LEAFLET<br>* Other names: PERMETRIN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY | AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically | 17 DAYS | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,, ARRUDA, RUTA