Efficacy and Safety Study for PIOLIN® Shampoo

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966965

Acronym

ESPX

Enrollment

212

Registered

2013-10-22

Start date

2014-07-31

Completion date

2014-10-31

Last updated

2013-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PEDICULOSIS

Keywords

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

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.

Interventions

DRUGPIOLIN®

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

DRUGNEDAX

AS SPECIFIED AT THE LEAFLET

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Contacts

Primary ContactKARLA F DEUD JOSÉ, PharmD PhD

karla@phytopharm.com.br55 51 9279-3075

Backup ContactKarla F Deud José, PharmD PhD

karladeud@gmail.com55 51 3231-7876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026