Efficacy and Safety Study for PIOLIN® Shampoo
ESPX
Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
1 other identifier
interventional
212
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 23, 2013
October 1, 2013
2 months
October 17, 2013
October 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EFFICACY
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically
17 DAYS
Secondary Outcomes (1)
SAFETY
30 DAYS
Study Arms (2)
PIOLIN®
EXPERIMENTALPIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
NEDAX
ACTIVE COMPARATORFOLLOWING THE LEAFLET TREATMENT
Interventions
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ubs Fatima
Pelotas, Rio Grande do Sul, 96075-540, Brazil
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MONICA M MENDES, MD MSc
UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS
- STUDY CHAIR
ACHILLES GENTILINI NETO, MD
INDEPENDENT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- CEO
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 22, 2013
Study Start
July 1, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
October 23, 2013
Record last verified: 2013-10