NCT05379114Unknown不适用
Comparative, Monocentric Study for the Evaluation of the Non-inferiority of a New Medical Device on the Treatment of Head Lice Infestation
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Perrigo CSCI
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- 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 item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes.
The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device for lice infestation treatment compared to a comparator device, 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
- •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
- •In terms of population
- •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 to 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 (type 4a to 4c in the hair type scale above)
- •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 or comparator 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
Cure Rate after complete treatment
时间窗: day 14
The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.
次要结局
- Live lice and nymphs, after application(Day 1 and Day 8 if applicable)
- Dead and live lice/nymphs and number of eggs after combing(Day 0 and Day 7 if applicable)
- Number of participants with treatment-related adverse events as assessed by investigator(Day 0, 7, 8 and 14 if applicable)
- Cure rate after one dose of Investigational device (ID)(Day 7)
- Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data(Day 7 or Day14)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice InfestationHead Lice InfestationNCT06057506Perrigo CSCI136
已完成
不适用
Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis CapitisPediculus CapitisPruritusNCT04415034Indonesia University357
已完成
3 期
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon IslandsHead LiceScabiesNCT03236168London School of Hygiene and Tropical Medicine118
撤回
不适用
Efficacy and safety of (a) A-Lfor Plasmodium falciparum and (b) P-A for Plasmodium falciparum and Plasmodium vivax malaria in Ta-mu Township, Sagaing Regiomalaria related feverheadacheachemailaiseloss of appetitePublic Health - Other public healthInfection - Other infectious diseasesACTRN12618001476224WHO country office50
已完成
不适用
A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head LiceHead LiceNCT01803581Oystershell NV60