CTRI/2025/03/082343尚未招募Post Marketing Surveillance
A clinical study to evaluate the 72-hours Moisturization potential of Galaxy (SA-CS-GD-1 and SA-CS-B-1) on healthy human volunteers
Galaxy Surfactants Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年3月19日最近更新:
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
研究概览
简要总结
Test Product:
1. SA-CS-GD-1 (Cream with active)
2. SA-CS-B-1 (Base Cream)
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 72 hours
研究设计
- 研究类型
- Pms
- 分配方式
- Not Applicable
- 盲法
- Open Label
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 18 to 40
- •Subjects willing to give written informed consent
- •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).
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 years, or any other confounding skin condition.
- •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.
结局指标
主要结局
Change in hydration
时间窗: T0min, T30min, T+2hrs, T+8hrs, T+24hrs, T+ 48hours, T+72hrs
次要结局
- Change in TEWL(t0min, t30min, t24hrs, t48hrs, t72hrs)
研究者
研究点 (1)
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