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Efficacy and Safety Study for PIOLIN® Shampoo (ESPX)

Primary Purpose

PEDICULOSIS

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
PIOLIN®
NEDAX
Sponsored by
Phytopharm Consulting Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PEDICULOSIS focused on measuring PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,, ARRUDA, RUTA

Eligibility Criteria

2 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ubs Fatima

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PIOLIN®

NEDAX

Arm Description

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

FOLLOWING THE LEAFLET TREATMENT

Outcomes

Primary Outcome Measures

EFFICACY
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically

Secondary Outcome Measures

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

Full Information

First Posted
October 17, 2013
Last Updated
October 22, 2013
Sponsor
Phytopharm Consulting Brazil
Collaborators
Laboratório Saúde Ltda - principal e único patrocinador
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1. Study Identification

Unique Protocol Identification Number
NCT01966965
Brief Title
Efficacy and Safety Study for PIOLIN® Shampoo
Acronym
ESPX
Official Title
Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phytopharm Consulting Brazil
Collaborators
Laboratório Saúde Ltda - principal e único patrocinador

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PEDICULOSIS
Keywords
PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,, ARRUDA, RUTA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIOLIN®
Arm Type
Experimental
Arm Description
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
Arm Title
NEDAX
Arm Type
Active Comparator
Arm Description
FOLLOWING THE LEAFLET TREATMENT
Intervention Type
Drug
Intervention Name(s)
PIOLIN®
Other Intervention Name(s)
RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT
Intervention Description
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
Intervention Type
Drug
Intervention Name(s)
NEDAX
Other Intervention Name(s)
PERMETRIN
Intervention Description
AS SPECIFIED AT THE LEAFLET
Primary Outcome Measure Information:
Title
EFFICACY
Description
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically
Time Frame
17 DAYS
Secondary Outcome Measure Information:
Title
SAFETY
Description
IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams
Time Frame
30 DAYS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KARLA F DEUD JOSÉ, PharmD PhD
Phone
55 51 9279-3075
Email
karla@phytopharm.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Karla F Deud José, PharmD PhD
Phone
55 51 3231-7876
Email
karladeud@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MONICA M MENDES, MD MSc
Organizational Affiliation
UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ACHILLES GENTILINI NETO, MD
Organizational Affiliation
INDEPENDENT
Official's Role
Study Chair
Facility Information:
Facility Name
Ubs Fatima
City
Pelotas
State/Province
RS
ZIP/Postal Code
96075-540
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MONICA M MENDES, MD MSc
Phone
55 53 9155-2139
Email
MONIKETHI@GMAIL.COM
First Name & Middle Initial & Last Name & Degree
MONICA M MENDES, MD MSc

12. IPD Sharing Statement

Links:
URL
http://lattes.cnpq.br/8425815106310226
Description
Brazilian researchers and professors site

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Efficacy and Safety Study for PIOLIN® Shampoo

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