Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Perrigo CSCI
- 入组人数
- 180
- 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 shampoo 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
- 否
入选标准
- •Healthy participant,
- •Female or male participants,
- •Aged 2 years and above (for participants in arms 1 and 2),
- •Aged 3 years and above (for participants in arms 3) ,
- •Participants with a slight to moderate lice infestation (According to EU norms: 0, 1, 2)
- •Participants with various hair types (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair not exceeding shoulder).
- •Written informed consent for participants ≥18 years or legal guardian for participants <18 years given freely and expressly before start of the clinical investigation.
- •Participant/Participant's legal guardian is psychologically able to understand the clinical investigation related information and to give written informed consent.
- •Participant/participant's legal guardian agreeing to follow the study requirements during the whole clinical investigation period.
- •Females of childbearing potential and sexually active should use a contraceptive regimen recognized as effective at least 4 weeks before the beginning of the clinical investigation and during the entire clinical investigation.
- •Female participants of childbearing potential, presenting with negative pregnancy test at inclusion.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
- •Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
- •Participant in a social or sanitary establishment;
- •Participant being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.
- •Participant suspected to be non-compliant according to the Investigator's judgment.
- •Participant allergic to any of the ingredients and/or materials of the intended to be used products (investigation device and anti-lice comb, comparative device, post-treatment shampoo).
- •Participant with curly hair (from 4A to 4C in the hair type scale).
- •Participant with hair length exceeding shoulder.
- •Participants with more than 24 lice on the head.
- •Participant suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the clinical investigation results.
- •Participant with a cutaneous disease on the studied zone (scalp and hair).
- •Severe scratches or open wounds/skin damage on the scalp (lice bites allowed however).
- •Participant with a known or suspected allergy to one or more of the components of the investigational or comparator devices.
- •Participant who has diabetes.
- •Participant with known or suspected immune deficiency or autoimmune disease.
- •Participant 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 clinical investigation;
- •corticosteroids during the 2 previous weeks and during the clinical investigation;
- •retinoids and/or immunosuppressors during the 3 previous months and during the clinical investigation ;
- •any medication stabilized for less than one month.
- •Participant who received an anti-lice treatment in the previous month.
研究组 & 干预措施
INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES
New medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ®
干预措施: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes (Other)
INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES
New medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ®
干预措施: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes (Other)
COMPARATOR DEVICE, Pouxit ® shampoo
Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ®
干预措施: COMPARATOR DEVICE, Pouxit ® (Other)
结局指标
主要结局
Cure Rate after complete treatment
时间窗: 7 days
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.
Cure Rate after complete treatment
时间窗: 14 days
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
- Cure rate after one dose of Investigational device (ID)(Day 7)
- Number of dead and live lice/nymphs after treatment(Day 0 and Day 7 if applicable)
- Number of live lice and nymphs, after application of treatment(Day 1 and Day 8 if applicable)
- Number of participants with treatment-related adverse events as assessed by investigator(Day 0, Day 1, Day 7, Day 8 and Day 14 if applicable)
- Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data(Day 1 , Day 7 or Day 14 if applicable)