NCT04878276招募中不适用
Randomised, Investigator-blinded, Controlled, Multicentre Comparative Study on the Treatment of Head Lice Infestation With 2 Dimeticone Preparations With Different Application Times and Compositions: Dimet 5® (100% Dimeticon) Versus Hedrin® Once Liquid Gel (4% Dimeticon + Nerolidol)
Infectopharm Arzneimittel GmbH26 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 26
- 主要终点
- Freedom from infestation
研究概览
简要总结
Randomized, investigator-blinded, controlled, multicenter comparative study on the treatment of acute head lice infestation in children with 2 dimeticone preparations with different application times and compositions: Dimet 5® (100% dimeticone) versus Hedrin® Once Liquid Gel (4% dimeticone + nerolidol) with treatment success assessment via freedom from infestation of live head lice at final examination at V2, i.e. day 19 after first treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute head lice infestation
- •Age ≥ 6 months
- •Adequate informed consent for study participation:
- •Age-appropriate informed consent and verbal informed consent from the patient (if capable of both).
- •Written informed consent from the legal guardian(s) (written and verbal).
排除标准
- •Adults (≥ 18 years of age)
- •Known hypersensitivity to any component of the test or comparator product.
- •Scalp lice therapy in the previous 2 weeks (with an appropriate drug or medical device).
- •Severe disease of the scalp or injuries/open wounds on the hairy head
- •Secondary infection in the area of the hairy head
- •Treatment with cotrimoxazole or trimethoprim in the last 4 weeks or new treatment to be initiated now
- •Other relevant reasons, e.g. diseases or dysfunctions, which, in the opinion of the investigator, militate against the inclusion of the patient in the study (including risk factors for severe COVID-19 disease in the case of SARS-CoV-2 infection)
- •Simultaneous participation of another household member in the trial.
- •Previous participation in this trial
- •Participation in another trial within the last 30 days
- •Inability of the legal guardian(s) to understand the study content and instructions.
- •Limited legal capacity of the legal guardian(s)
- •Apparent unreliability or unwillingness to cooperate on the part of the legal guardian(s)
- •Known alcohol, medication or drug dependency of the legal guardian(s)
- •Dependence of the patient or guardian on the sponsor or investigator.
结局指标
主要结局
Freedom from infestation
时间窗: Day 17 to 21
Freedom from infestation of live head lice at the final examination (V2)
次要结局
未报告次要终点
研究者
研究点 (26)
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