ISRCTN77673809已完成未知
A randomised, assessor-blinded clinical study to compare the efficacy and safety of Nice 'n Clear with Full Marks solution and to evaluate a novel ultrasound comb device 'ClearBrush' for removal of nits
elsons (UK)0 个研究点目标入组 134 人开始时间: 2008年2月5日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 134
研究概览
简要总结
2017 results in https://biomeddermatol.biomedcentral.com/articles/10.1186/s41702-017-0009-0 (added 30/10/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male and female participants who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found. Any lice found at these assessments will not be removed
- •2. Participants who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. An assent form will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit. The lower age limit for this study will be 2 years (Nice 'n Clear is marketed as a medical device for babies and children down to the age of 6 months and Full Marks solution for children down to 2 years)
- •3. Participants must be available for the duration of the study, i.e. 15 days
排除标准
- •1. Participants who have been treated with other head louse products within the previous 2 weeks (14 days)
- •2. Participants who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course
- •3. Participants whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks; this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable.
- •4. Participants who have taken part in another clinical study within 4 weeks prior to entry to this one
- •5. Female participants who are pregnant or breastfeeding
- •6. Participants who have already taken part in this study
- •7. Participants who have a known allergy to any of the ingredients of either of the Nice 'n Clear preparations or Full Marks solution (including allergy to Paraben preservatives)
- •8. Children under 2 years of age
研究者
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