NCT06057506招募中不适用
Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Perrigo CSCI
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Efficacy based on the cure rate after complete treatment
研究概览
简要总结
Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation.
The test items have been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimative convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The main objective of this clinical study is to confirm the efficacy on head lice treatment of two Medical Devices, already in market.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject;
- •Sex: male or female;
- •Age: 2 years and above;
- •Subject with a slight to moderate lice infestation (according to EU norms);
- •Subjects with various hair type (from 1 to 3C - hair scale) and hair length (from short to mid length hair, not exceeding shoulder);
- •Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study;
- •Written informed consent for subjects ≥18 years or legal guardian for subjects < 18 years given freely and expressly before start of the study;
- •Written assent for subjects ≥12 to <18 years;
- •Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent;
- •Females of childbearing potential must have a negative pregnancy test before the beginning of the study.
排除标准
- •Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
- •Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
- •Subject in a social or sanitary establishment;
- •Subject in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit;
- •Subject suspected to be non-compliant according to the investigator's judgment;
- •Subject with curly or frizzy hair (from 4A to 4C in the hair type scale);
- •Subject with hair length below the shoulder;
- •Subjects with more than 24 lice on the head.
- •In terms of associated pathology
- •Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
- •Subject with a cutaneous disease on the studied zone (scalp and hair);
- •Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however);
- •Subject with a known or suspected allergy to any of the components/materials of the investigational devices, anti-lice comb or post-treatment shampoo;
- •Subject who has diabetes (type 1 or 2);
- •Subject with known or suspected immune deficiency or autoimmune disease.
- •Relating to previous or ongoing treatment
- •Subject undergoing a topical treatment on the test area or a systemic treatment with:
- •anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
- •corticosteroids during the 2 previous weeks and during the study;
- •retinoids and/or immunosuppressors during the 3 previous months and during the study;
- •any medication stabilized for less than one month.
- •Subject who received an anti-lice treatment in the previous 2 months.
结局指标
主要结局
Efficacy based on the cure rate after complete treatment
时间窗: Day 7, Day 14 if applicable
The cure rate is defined as the rate of subjects having no live lice on hair 7 days after the last application of the product (Day 7 or Day 14 if second application is needed).
次要结局
- Number of participants with treatment-related adverse events, serious adverse events as assessed by investigator(Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable)
- Dead and live lice/nymphs after combing(Day 0, Day 7 if applicable)
- Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire(Day 1, Day 7 or Day 14 if applicable)
- Cure rate after one dose of investigational device application(Day 7)
- Cure rate of each individual investigational device(Day 7, Day 14)
- Live lice and nymphs after application(Day 1, Day 7, Day 8 if applicable, Day 14 if applicable)
研究者
研究点 (1)
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