CTRI/2024/09/074385已完成Unknown
A Clinical Study to Evaluate the tan reduction activity of Plum SPF 35 PA 3 Plus Body Lotion
Pureplay Skin Sciences Pvt Ltd1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1. skin Hydration- Corneometer
研究概览
简要总结
A study to evaluate the tan reduction of SPF 35 PA+++ Body Lotion
Assessment Time: Day0, Day14
Following test parameter will be evaluated at the study period
-
X% tan Reduction
-
Increment in hydration
3.X% improvement in skin
4. Change in temperature
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
- •Gender: Male or Female with age 18-40 (ratio 20:80) 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
- •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 including sensitivities 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
1. skin Hydration- Corneometer
时间窗: T+0,T+30, T+14 Days
2. Measure the skin temperature
时间窗: T+0,T+30, T+14 Days
3. skin Gloss with Glossymeter
时间窗: T+0,T+30, T+14 Days
4. skin lightness- Chromameter
时间窗: T+0,T+30, T+14 Days
5. X% Tan Reduction
时间窗: T+0,T+30, T+14 Days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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