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Efficacy and Safety Study for PIOLIN® Shampoo

NCT01966965 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2013-10-23

No results posted yet for this study

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

DRUG

PIOLIN®

PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN

DRUG

NEDAX

AS SPECIFIED AT THE LEAFLET

Sponsors & Collaborators

  • Laboratório Saúde Ltda - principal e único patrocinador

    collaborator UNKNOWN

  • Phytopharm Consulting Brazil

    lead NETWORK

Principal Investigators

  • MONICA M MENDES, MD MSc · UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS

  • ACHILLES GENTILINI NETO, MD · INDEPENDENT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01966965 on ClinicalTrials.gov