CTRI/2024/08/072512已完成Unknown
A Pilot Study to Evaluate the skin lightness activity of Silphion S-33 on Healthy Human Subjects
SILPHION RESEARCH PRIVATE LIMITED,1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月24日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in
研究概览
简要总结
Clinical study to evaluate the Skin Lightness Activity Of Silphion S-33
1. Silphion S-33
The products will be tested on 10 human volunteers.
Assessment would Notice the improvement in Melanin content, Hydration and skin Lightness with follow-up visits on Day 0, and Day 7 with Follow up measure on 8th day.
The study is done as per BIS standard 4011
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary man or women between 20 and 45 years.
- •Photo type V.
- •People with oily skin.
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
- •Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
排除标准
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Dermatological infection or pathology on the level of studied area.
- •4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) 5.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 6.Chronic illness which may influence the outcome of the study.
- •7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) 8.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
结局指标
主要结局
Change in
时间窗: Day0, Day7
1. Melanin Index
时间窗: Day0, Day7
2. Lightening index
时间窗: Day0, Day7
3. Hydration
时间窗: Day0, Day7
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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