CTRI/2025/08/093160尚未招募Post Marketing Surveillance
A Clinical Study to evaluate the 24hrs Moisturization Study of Krauter Healthcare Barrier Repair Cream and Oil free Gel Moisturizer on healthy human volunteers
Krauter Healthcare Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月25日
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in hydration, TEWL
研究概览
简要总结
Test Product:
1. Barrier Repair Cream
2. Oil free Gel Moisturizer
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hours
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
入选标准
- •Gender: Male or Female with age 18-40 2) Subjects willing to give written informed consent 3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have open sores or open lesions in the treatment area(s).
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 90 days.
- •Have a known sensitivity to any of the constituents of the test product.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e.,biologics), including corticosteroids.
- •Have not skin related issues.
结局指标
主要结局
Change in hydration, TEWL
时间窗: T0min, T+30min, T2hours, T+8hours, T+24hrs
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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