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Efficacy and Safety Study for PIOLIN® Shampoo

NCT ID: NCT01966965

Last Updated: 2013-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-10-31

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.

Detailed Description

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Conditions

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PEDICULOSIS

Keywords

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PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE, ARRUDA, RUTA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PIOLIN®

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

Group Type EXPERIMENTAL

PIOLIN®

Intervention Type DRUG

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

NEDAX

FOLLOWING THE LEAFLET TREATMENT

Group Type ACTIVE_COMPARATOR

NEDAX

Intervention Type DRUG

AS SPECIFIED AT THE LEAFLET

Interventions

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PIOLIN®

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

Intervention Type DRUG

NEDAX

AS SPECIFIED AT THE LEAFLET

Intervention Type DRUG

Other Intervention Names

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RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT PERMETRIN

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratório Saúde Ltda - principal e único patrocinador

UNKNOWN

Sponsor Role collaborator

Phytopharm Consulting Brazil

NETWORK

Sponsor Role lead

Responsible Party

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Karla F. Deud Jose

CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MONICA M MENDES, MD MSc

Role: PRINCIPAL_INVESTIGATOR

UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS

ACHILLES GENTILINI NETO, MD

Role: STUDY_CHAIR

INDEPENDENT

Locations

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Ubs Fatima

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Central Contacts

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KARLA F DEUD JOSÉ, PharmD PhD

Role: CONTACT

Phone: 55 51 9279-3075

Email: [email protected]

Karla F Deud José, PharmD PhD

Role: CONTACT

Phone: 55 51 3231-7876

Email: [email protected]

Facility Contacts

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MONICA M MENDES, MD MSc

Role: primary

Related Links

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http://lattes.cnpq.br/8425815106310226

Brazilian researchers and professors site

Other Identifiers

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ESPX2013

Identifier Type: -

Identifier Source: org_study_id