Efficacy and Safety Study for PIOLIN® Shampoo (ESPX)

Phytopharm Consulting Brazil

Status and phase: Unknown; Phase 3

Conditions: PEDICULOSIS

Treatments: Drug: NEDAX; Drug: PIOLIN®

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01966965

ESPX2013

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 2 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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212 participants in 2 patient groups

PIOLIN®

Experimental group

Description:

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

Treatment:

Drug: PIOLIN®

NEDAX

Active Comparator group

Description:

FOLLOWING THE LEAFLET TREATMENT

Treatment:

Drug: NEDAX