Efficacy and Safety Study for PIOLIN® Shampoo (ESPX)

October 22, 2013 updated by: Karla F. Deud Jose, Phytopharm Consulting Brazil

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Karla F Deud José, PharmD PhD
  • Phone Number: 55 51 3231-7876
  • Email: karladeud@gmail.com

Study Locations

  • Brazil
    • RS
      • Pelotas, RS, Brazil, 96075-540
        • Ubs Fatima
        • Contact:
        • Principal Investigator:
          • MONICA M MENDES, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PIOLIN®
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
Drug: PIOLIN®
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
Other Names:
  • RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT
Active Comparator: NEDAX
FOLLOWING THE LEAFLET TREATMENT
Drug: NEDAX
AS SPECIFIED AT THE LEAFLET
Other Names:
  • PERMETRIN

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFETY
Time Frame: 30 DAYS
IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams
30 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phytopharm Consulting Brazil

Collaborators

Laboratório Saúde Ltda - principal e único patrocinador

Investigators

  • Principal Investigator: MONICA M MENDES, MD MSc, UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS
  • Study Chair: ACHILLES GENTILINI NETO, MD, Independent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPX2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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