NCT01966965

Efficacy and Safety Study for PIOLIN® Shampoo

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Phytopharm Consulting Brazil · Network
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• PEDICULOSIS

Interventions

Type	Name	Description
DRUG	PIOLIN®	PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
DRUG	NEDAX	AS SPECIFIED AT THE LEAFLET

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-10-22
• Last updated: 2013-10-23

Locations

1 site across 1 country: Brazil