NCT00758823已完成不适用
Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)
Omega Pharma2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- statistical analysis will compare the number of successes and failures for each products
研究概览
简要总结
THe main goal of our randomized controlled trial with blinded observer will be to compare four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority (20% equivalence). THe randomization will be balanced every 10 families. The secondary objective will be to compare the lenticide efficacy of the products and their local tolerance and cosmetic acceptibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject-male or female, child > 3 years and adult
- •Pediculosis of scalp, confirmed by the identification of minimum 5 live lice with a fine-tooth comb
- •Negative urine pregnancy test before inclusion for women of childbearing potential
- •Use of a contraceptive method by hormonal contraceptives or IUDs or tubal ligation or condoms for women of childbearing potential
- •Subject agreeing to participate in the study with written informed consent for participation
- •Written consent of both parents for the minor patients.
排除标准
- •Children under 3 years.
- •Woman pregnant or lactating or without contraception
- •Use of a pediculicide or lenticide treatment within 2 weeks before entry into the study
- •Subject with known hypersensitivity to any component of the tested products
- •Subject who participated in a clinical study in the 3 months prior to inclusion
- •Ongoing treatment potentially interacting with the treatment under study (other pediculicide products)
- •Subject undertreatment susceptible to influence the evaluation of the trial (including trimethoprim-sulfamethoxazole).
- •Severe medical or psychiatric illness considered by the investigator as potentially dangerous to the subject or incompatible with the conduct of the study
- •Subject unable for linguistic or psychiatric reasons to understand the information and give informed consent
- •Subject refusing to give written consent
- •Subject deprived of his liberty by administrative or judicial decision, or guardianship
- •Patient hospitalized in a medical or social facility for another reason that biomedical research
结局指标
主要结局
statistical analysis will compare the number of successes and failures for each products
时间窗: Day 1, Day 7 and day 14
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
3 期
Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary BypassPrevention of Venous ThromboembolismNCT01072747Azidus Brasil104
已完成
不适用
A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic VersionPregnancyPainNCT01991743Northwestern University240
已完成
不适用
Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal DiseaseEnd Stage Renal DiseaseHemodialysisIntimal Media ThicknessNCT01049815Tel-Aviv Sourasky Medical Center175
招募中
不适用
An Online Ecoaching RCT Intervention for Carers: Enhancing Wellbeing and Resilience Through Self-Help StrategiesCaregiver BurdenSelf EfficacyQuality of LifeAnxiety DepressionResilienceNCT06604481The University of Hong Kong232
已完成
2 期
Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training ProgramMuscle StrengthNCT04814225Roquette Canada, LTD.100