Efficacy and Safety Study for PIOLIN® Shampoo

PEDICULOSIS Clinical Trial

— ESPX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01966965
• Other study ID #: ESPX2013
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 17, 2013
• Last updated: October 22, 2013
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2013
• Source: Phytopharm Consulting Brazil
• Contact: KARLA F DEUD JOSÉ, PharmD PhD
• Phone: 55 51 9279-3075
• Email: karla[@]phytopharm.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 212
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lice Infestations
• PEDICULOSIS

Intervention

Drug:
• PIOLIN®
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
• NEDAX
AS SPECIFIED AT THE LEAFLET

Locations

Country	Name	City	State
Brazil	Ubs Fatima	Pelotas	RS

Sponsors (2)

Lead Sponsor	Collaborator
Phytopharm Consulting Brazil	Laboratório Saúde Ltda - principal e único patrocinador

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFICACY	AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically	17 DAYS	No
Secondary	SAFETY	IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams	30 DAYS	Yes

External Links

•   Brazilian researchers and professors site