CTRI/2024/01/061774已完成Post Marketing Surveillance
A Clinical Study to evaluate the 24-hours moisturization potential of Avimee Padmini moisturizing lotion.
Avimee Herbal Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月27日最近更新:
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Moisture
研究概览
简要总结
The below product would be tested as per the guideline IS4011 for dermal safety assessme****nt.
1. Padmini Moisturising Lotion.
Test Product- Avimee Padmini Moisturizing lotion Dose: Gently massage approx. 1 drop of Moisturizing lotion over one block as assigned (forearm) Route of Administration: Topical Duration: 24 hour
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 50.00 Year(s)（—）
入选标准
- •Gender: Male or Female 18 to 50
- •Subjects willing to give written informed consent
- •Women of childbearing 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.
- •Have any condition that, in the opinion of the investigator, would confound the safety and or 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 Moisture
时间窗: T0min, T+30 mins, T+ 2 hours, T+4 hours, T+ 6 hours, T+8 hours , T+ 24 hours
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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