NCT05732337已完成不适用
Prospective, Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device for the Treatment of Chickenpox Symptoms
Karo Pharma AB1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年1月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox (using 5-point scale,"none (0)" to "severe (4)" ) will be evaluated after 3 days.
研究概览
简要总结
The primary endpoint is the change of the itching score after 3 days of the product use in comparison to the basal value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and/or male
- •Aged between 12 months to 11 years
- •phototype: I to IV
- •Subject or parent(s)/legal representative(s) must be registered with health social security or health social insurance.
- •Parent(s)/legal representative(s) having signed their written Informed Consent form (ICF) for their children's participation in the study
- •Subject and / or parent(s)/legal representative(s) able to understand the language used in the investigation centre and the information given
- •Subject or parent(s)/legal representative(s) able to comply with the protocol, follow protocol's constraints and specific requirements and able to follow the medical recommendation regarding the pathology and its requirements (treatment, social eviction etc)
- •Subjects presenting non severe and non complicated chicken pox
排除标准
- •Subject or parent(s)/legal representative(s) who is (are) unable to understand the information (for linguistic or psychiatric reasons) and to give his/her (their) consent to his/ her (their child) participation
- •Subject taking part or planning to participate in another clinical trial during the study in the same or another investigation centre
- •Subject or parent(s)/legal representative(s) deprived of freedom by administrative or legal decision or under guardianship
- •Subject or parent(s)/legal representative(s) admitted in a sanitary or social facility
- •Subjects planning a hospitalization during the study
- •Severe or complicated chicken pox (surinfection, profuse eruption, pneumonia, etc)
- •Having an acute, chronic, or progressive disease or dermatological condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Having personal medical history liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Being under any treatment for a severe or complicated chicken pox considered by the Investigator liable to interfere with the study data or incompatible with the study requirements (antiviral (Herviran) or antibiotics...)
- •Having taken any previous treatment considered by the Investigator liable to interfere with the study data or incompatible with the study requirements
- •Systemic antibiotics within 1 week before the inclusion or required during the study
- •Systemic immunosuppressive treatment within 6 months before the inclusion or required during the study
结局指标
主要结局
The efficacy of PoxClin® CoolMousse in relieving itching associated with chickenpox (using 5-point scale,"none (0)" to "severe (4)" ) will be evaluated after 3 days.
时间窗: 3 days
Children should be diagnosed with chickenpox.
次要结局
- The efficacy of the PoxClin® CoolMousse in relieving itch during chickenpox (using 5 point scale, "none (0)" to "severe (4)"): itching) will be evaluated after 7 days.(7 days)
研究者
研究点 (1)
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