A Non-Randomized, Open-Label, Single-Center Study To Evaluate The Irritation And Sensitization Potential Of Bumsuit Baby Products In Healthy Volunteer Children Using The Human Repeat Insult Patch Test (HRIPT).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measured by visual assessment and scoring (e.g., Erythema, Edema) using a standardized grading scale at various time points during the induction phase.
研究概览
简要总结
Background and Introduction
The early stages of life are recognized as critical for the healthy development of children, and proper skincare plays an essential role in promoting long-term well-being. During childhood and adolescence, the skin undergoes various changes, making it necessary for skincare products to be both effective and safe. Bumsuit Baby Products, commonly used to moisturize and protect the skin, are carefully evaluated to ensure they do not cause irritation or sensitization, particularly in children and adolescents, whose skin is more sensitive than that of adults.
The study participants, representing a wide range of skin types, helped determine whether the products are suitable for use in children and adolescents. This research provided essential data to confirm the safety profile of Bumsuit Baby Products, ensuring they meet safety standards and can be used confidently by parents, caregivers, and healthcare professionals.
Purpose of the Study
The purpose of the study was to evaluate the safety and efficacy of Bumsuit Baby Products in moisturizing and protecting the sensitive skin of children and adolescents. By including participants with diverse skin types, the study aimed to confirm that these products did not cause irritation or sensitization and met established safety standards. The findings provided critical data to support the safe and confident use of Bumsuit Baby Products by parents, caregivers, and healthcare professionals for maintaining healthy skin in young individuals.
Results
The study was conducted over a 21-day period for each participant.The study enrolled 24 healthy children aged between 5 to 18 years. All 24 participants completed the study without any discontinuations, resulting in a 100% subject completion and compliance rate. The mean (SD) age of the participants was 11.95 (4.14) years.
**Primary Outcomes:**Dermatological assessments conducted using the Draize scale showed that none of the participants exhibited any signs of erythema (redness), edema (swelling), dryness, or skin flaking at any of the evaluated time points. All four products **Bumsuit Baby Cream, Lotion, Massage Oil, and Shampoo,**were rated as non-irritating and well-tolerated.
**Secondary Outcomes:**Self-assessments by participants (or their guardians) confirmed the absence of any sensations of burning, itching, tingling, scaling, or discomfort throughout the 21-day study period. No acute or delayed hypersensitivity reactions were reported.
**Safety Profile:**No adverse events (AEs) or serious adverse events (SAEs) were observed. There were no protocol deviations or dropouts.
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
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy volunteers aged 5 to 18 years.
- •Subjects with no clinically significant dermatological conditions e.g., eczema, psoriasis.
- •Subjects whose guardians/parents have provided Informed Consent.
- •Willing to adhere to study restrictions no use of other skincare products in the test area.
排除标准
- 未提供
结局指标
主要结局
Measured by visual assessment and scoring (e.g., Erythema, Edema) using a standardized grading scale at various time points during the induction phase.
时间窗: Day 0, Day 1, Day 2, Day 3 and Day 7, Day 14 and Day 21
次要结局
- Evaluated through participant-reported outcomes regarding skin discomfort, dryness, or other adverse effects through a standardized questionnaire.(Day 0, Day 1, Day 2, Day 3 and Day 7, Day 14 and Day 21)
研究者
Dr Uday Kumar S
Currex Hospital Bangalore