Safety and Tolerability Evaluation of Baby Oils in Healthy Babies and Children.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the safety, tolerability, and effectiveness of test products in improving scalp, hair, and overall skin condition in infants. Subjects aged 0-36 months who meet the eligibility criteria will be enrolled after obtaining written informed consent from their parent or legal guardian. Demographic details and medical history will be collected at baseline. Eligible subjects will be randomized into two groups, with 35 subjects randomized per group. Parents or legal guardians will apply the assigned products daily for 7 consecutive days and will be instructed not to use any other oils, lotions, moisturizers, or home remedies during the study period. Assessments will include parental and investigator evaluation of overall scalp and hair condition, overall skin condition, safety and tolerability, and the baby’s quality of life. Follow-up assessments will be conducted on Day 8, and feedback on overall product performance will be obtained at the end of the study. The total clinical study duration will be up to 8 days per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Month(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Subjects in good health as determined from a recent medical history and physical examination.
- •Subjects whose parent/legal representative, preferably the mother, is willing to provide voluntary written parental informed consent and agrees to abide by, comply with the study protocol, and attend regular follow-up visits.
- •Subjects should not participate in any other clinical study during participation in the current study.
排除标准
- •Subjects above 36 months of age.
- •Subjects with known history or current allergic conditions requiring medical attention, or chronic illnesses that may influence the cutaneous assessment.
- •Subject’s mother/legal representative not willing to stop the use of other lotions/oils during the study period.
- •Subjects on any systemic medication or with birth defects and chromosomal or metabolic anomalies.
- •Subjects participating in a similar clinical study currently or within the previous 30 days.
- •Subjects with medical history (past or present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiological response (porphyria), chronic urticaria, or sunburn, rashes.
- •Subjects judged by the investigator to be inappropriate for this trial.
研究者
Dr Namana
BGS Global Institute of Medical Sciences