Clinical Evaluation of Pediatric Acceptability of a Cosmetic Product
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Pediatric dermatological acceptability assessed by pediatrician clinical evaluation
研究概览
简要总结
The goal of this clinical trial is to evaluate the dermatological safety and acceptability of a cosmetic product in healthy pediatric participants. The main questions it aims to answer are:
- Does the investigational product demonstrate pediatric acceptability under normal conditions of use?
- Does the investigational product present a low risk of skin irritation in the pediatric population?
- Are any discomfort sensations reported during product use?
Participants will:
- Apply the investigational product to the face and body twice daily for 21 days.
- Undergo clinical evaluations to assess skin tolerability and identify any signs of irritation or adverse reactions.
- Be monitored for potential discomfort sensations throughout the study period. The study will enroll 33 healthy male and female participants aged from 7 days to 14 years. This is a single-center, single-blind clinical trial designed to evaluate the safety of the investigational product through clinical assessments under normal conditions of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants aged from 7 days to 14 years.
- •Participants whose parent(s) and/or legal guardian(s) agree to comply with all study procedures and attend the study site on the scheduled dates and times for assessments.
- •Parent(s) and/or legal guardian(s) able to understand the study requirements and provide written informed consent by signing the Informed Consent Form (ICF) prior to the performance of any study-specific procedures.
- •When applicable, participants able to understand and provide assent by signing the Assent Form, according to their age, maturity, and level of understanding.
- •Inclusion of at least one newborn participant.
排除标准
- •Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
- •Skin conditions or marks in the test area that may interfere with the evaluation of potential skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
- •History of atopy or allergic reactions to cosmetic products.
- •Active skin diseases and/or lesions (localized or widespread) in the assessment area.
- •Immunosuppression due to medication use or active disease.
- •Uncontrolled endocrine disorders.
- •Known history of or suspected intolerance to products of the same category.
- •Intense sun exposure within 15 days prior to assessment.
- •Aesthetic or dermatological treatments within 4 weeks prior to assessment.
- •Any other condition that, in the investigator's opinion, may reasonably justify exclusion from the study
研究组 & 干预措施
Cosmetic Product Group
Healthy male and female pediatric participants aged from 7 days to 14 years will apply the investigational cosmetic product to the face and body twice daily for 21 days under normal conditions of use. Clinical evaluations will be performed throughout the study period to assess dermatological acceptability, skin tolerability, signs of irritation, and potential discomfort sensations.
干预措施: moisturizing cream (Other)
结局指标
主要结局
Pediatric dermatological acceptability assessed by pediatrician clinical evaluation
时间窗: Baseline and Day 21
Dermatological acceptability of the investigational product in pediatric participants under normal conditions of use, assessed by a pediatrician through clinical evaluation of skin integrity, signs of irritation, and the occurrence of adverse events at Baseline and Day 21.
Participant-reported tolerability assessed through daily use diary
时间窗: Day 21
Tolerability of the investigational product assessed through information recorded by parents or legal guardians in the daily use diary, including reports of discomfort sensations, signs of intolerance, and adverse events during the 21-day product use period.
次要结局
未报告次要终点