Efficacy and Safety Study for PIOLIN® Shampoo (ESPX)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Phytopharm Consulting Brazil
Sponsor:
Collaborator:
Laboratório Saúde Ltda - principal e único patrocinador
Information provided by (Responsible Party):
Karla F. Deud Jose, Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier:
NCT01966965
First received: October 17, 2013
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
PEDICULOSIS
Drug: PIOLIN®
Drug: NEDAX
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis

Resource links provided by NLM:


Further study details as provided by Phytopharm Consulting Brazil:

Primary Outcome Measures:
  • EFFICACY [ Time Frame: 17 DAYS ] [ Designated as safety issue: No ]
    AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically


Secondary Outcome Measures:
  • SAFETY [ Time Frame: 30 DAYS ] [ Designated as safety issue: Yes ]
    IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams


Estimated Enrollment: 212
Study Start Date: July 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT
Active Comparator: NEDAX
FOLLOWING THE LEAFLET TREATMENT
Drug: NEDAX
AS SPECIFIED AT THE LEAFLET
Other Name: PERMETRIN

  Eligibility

Ages Eligible for Study:   2 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966965

Contacts
Contact: KARLA F DEUD JOSÉ, PharmD PhD 55 51 9279-3075 karla@phytopharm.com.br
Contact: Karla F Deud José, PharmD PhD 55 51 3231-7876 karladeud@gmail.com

Locations
Brazil
Ubs Fatima Not yet recruiting
Pelotas, RS, Brazil, 96075-540
Contact: MONICA M MENDES, MD MSc    55 53 9155-2139    MONIKETHI@GMAIL.COM   
Principal Investigator: MONICA M MENDES, MD MSc         
Sponsors and Collaborators
Phytopharm Consulting Brazil
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
  More Information

Additional Information:
No publications provided

Responsible Party: Karla F. Deud Jose, CEO, Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01966965     History of Changes
Other Study ID Numbers: ESPX2013
Study First Received: October 17, 2013
Last Updated: October 22, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Phytopharm Consulting Brazil:
PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,
ARRUDA, RUTA

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014