CTRI/2026/03/105667尚未招募不适用
A Clinical Study to Evaluate the Safety and Tolerability of Tedibar Ceramax Head to Toe Bodywash in Paediatric Population.
Torrent Pharmaceuticals Ltd. Research Centre1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年3月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Participants will be screened according to the inclusion and exclusion criteria, and eligible participants will be enrolled after obtaining written parental consent.
The test product will be provided to parents/caregivers with instructions to use it during the child’s regular bathing routine at least once daily for 28 days.
Dermatological assessments, paediatrician’s evaluations, instrumental measurements of skin hydration, and parent/caregiver feedback will be conducted at Baseline, 30 minutes after the first application (Timm), Day 14 (Week 2), and Day 28 (Week 4).
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
- 1.00 Day(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Male and female trial participant in the age group, day 1 to 24 months of age on the day of enrolment.
- •Trial participant in general good health as determined by a paediatrician or dermatologist (as applicable) by a recent medical history.
- •Trial participant’s (parent or LAR) willing to give a voluntary written informed consent and agree to come for follow up.
- •Trial participant’s (parent or LAR) agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.
- •Trial participant’s (parent or LAR) willing to abide by and comply with the study protocol requirement for his/her child.
排除标准
- •A known history or present condition or any other concern that may require medical attention.
- •Trial participant deemed unfit to participate in the study based on the general health and hygiene
- •Trial participant having active skin diseases which will interfere with the test results.
- •Trial participant who has mild to moderate signs of local irritations like erythema, dryness, scaling/peeling, urticaria, acneiform eruptions, allergic reaction will be considered but severe signs will be avoided.
研究者
Dr Sharil P Hedge
MS Clinical Research Pvt. Ltd
研究点 (1)
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