Assessment of the Primary, Accumulated Irritability and Skin Sensitization Potential of an Elastic Collodion-based Liquid Bandage Under Controlled and Maximized Conditions (RIPT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Prove the absence of primary irritability potential of the experimental product under maximized conditions.
研究概览
简要总结
The investigational product constitutes a medical device that is freely accessible to consumers and, as such, must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market.
Therefore, this study was designed to evaluate the biocompatibility of the experimental product, as provided for in legislation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years old.
- •Fitzpatrick phototype I to IV.
- •Presence of intact skin in the test region.
- •Agreement to comply with the study procedures and requirements and attend the institute on the days and times determined for the assessments.
- •Signature of the Informed Consent Form (ICF) before carrying out any study procedure.
排除标准
- •Presence of skin marks in the test region that interfere with the assessment of possible skin reactions (for example, pigmentation disorders, vascular malformations, scars, increased hairiness, large quantities of ephelides and nevus, sunburn).
- •Presence of active dermatosis (local or disseminated) that could interfere with the study results.
- •istory of atopy (atopic dermatitis, allergic rhinitis, allergic bronchitis, allergic conjunctivitis, etc.).
- •- History of allergic reactions, irritation or intense sensations of discomfort to topical products such as, for example, cosmetics, health products or medicines.
结局指标
主要结局
Prove the absence of primary irritability potential of the experimental product under maximized conditions.
时间窗: 6 weeks
* Occurrence of primary irritation; * Occurrence of accumulated irritation; * Occurrence of sensitization; * Occurrence of AEs ; * Treatment discontinuations due to AEs . It is expected that after the study period, the product will be considered safe because it does not promote a positive irritability response and skin sensitization in the study group. No statistical inference analysis will be performed. The results will be presented in the form of tables demonstrating whether or not there was a positive response of irritability or skin sensitization in the study group. During the study, the regions of the product and control application will be evaluated and if any clinical sign is found, it will be classified according to the scale recommended by the International Contact Dermatitis Research Group - ICDRG - (FISHER, 1995).
次要结局
未报告次要终点