CTRI/2024/04/066437尚未招募不适用
A Clinical Study to evaluate the 24 hours moisturization potential of Aqualogica Barrier Repair Moisturizer.
Honasa Consumer 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5月10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
- 36
- 试验地点
- 1
- 主要终点
- To study the skin hydration
研究概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.
Subjects will be on study for 24hrs.
**Screening & Assigning:**Day 0
Test Product: Aqualogica Barrier Repair Moisturizer
Dose: Gently massage approx. 2-3 drop of serum over one block
Route of Administration: Topical
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
入选标准
- •1.Gender: Male or Female 18 to 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.
- •4.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.
- •5.Are willing to avoid prolonged exposure of the treatment area 5.To ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •3.Have open sores or open lesions in the treatment area(s).
- •4.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •5.Have participated in any interventional clinical trial in the previous 90 days.
- •6.Have a known sensitivity to any of the constituents of the test product 7.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •8.Have not skin related issues.
结局指标
主要结局
To study the skin hydration
时间窗: At T0, T+30Min, T+2hrs, T+4hrs, T+6hrs, T+8hrs, T+24hrs
次要结局
- To study the safety and tolerability(At T0 and 24 hrs)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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