A Clinical Trial to Assess the Dermatological and Ophthalmological Safety, Tolerability and Efficacy of the Baby Care Products in Healthy Neonates, Babies and Young Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
研究概览
简要总结
This study evaluates the safety, tolerability, and efficacy of multiple baby care products in pediatric subjects. After obtaining informed consent from the parent or legal guardian, eligible subjects will be enrolled and randomized into study groups, with 35 subjects being randomized per groups. Each group will receive assigned investigational products in two test periods of 7 days each, separated by a 7 day washout period. Parents/guardians will apply the products as instructed and record compliance and observations in a subject diary. Safety and efficacy assessments will be conducted by the investigator, Pediatrician, Dermatologist, and Ophthalmologist. The total study duration for the clinical part shall be a maximum of 21 days per groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with all skin types (dry, normal, oily, combination, sensitive, and eczema-prone), as assessed by a dermatologist, and in good general health based on medical history and physical examination.
- •Subject wearing diaper at least for 12 hours per day.
- •Parent or legal representative (preferably the mother) provides written informed consent and agrees to attend follow-ups and comply with the study protocol.
- •Subject must not participate in any other clinical study during this study.
排除标准
- •1.Subject above 6 years of age.
- •Subject with known allergy or chronic illness that may affect cutaneous assessment or require medical attention.
- •Subjects parent/legal representative not willing to stop use of other lotions during the study period, or the subject is on any systemic medication.
- •Subject with birth defects, chromosomal/metabolic anomalies, or significant dermatological diseases/conditions (e.g., atopy, psoriasis, vitiligo, porphyria, chronic urticaria, sunburn, rashes) that may alter skin appearance or physiological response.
- •Subject judged by the investigator to be inappropriate for this trial.
研究者
Dr Rohith HR
BGS Global Institute of Medical Sciences