Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- EFFICACY
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 .
排除标准
- •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
研究组 & 干预措施
PIOLIN®
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
干预措施: PIOLIN® (Drug)
NEDAX
FOLLOWING THE LEAFLET TREATMENT
干预措施: NEDAX (Drug)
结局指标
主要结局
EFFICACY
时间窗: 17 DAYS
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically
次要结局
- SAFETY(30 DAYS)
研究者
Karla F. Deud Jose
CEO
Phytopharm Consulting Brazil