CTRI/2018/05/013996已完成2 期
Evaluating Dermatological Safety and Malodor Control Efficacy of Test Products On Healthy Human Subjects Of Varied Skin Types
ITC Life Science and Technology Centre0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Equal distribution of gender (1:1)
- •2 Equal distribution of different skin types: Combination, Dry, Normal, Oily, Sensitive (As per modified Baumannââ?¬•s Skin Type questionnaire)
- •3 Age: 18 to 45 yrs
- •4 Volunteers in generally good health and not undergoing medical treatment
- •5 Volunteers without any cuts, marks and open wounds on both axillae
- •6 Volunteers free of any obvious infection of skin as determined by dermatologist
- •7 Volunteers with a malodor score above 2.5 on a scale of 0-5 with normal activity during the day with an odour difference of <1 between the right and left axillae as per the olfactory panel.
- •8 Volunteers willing to give a written informed consent
- •9 Volunteers willing to abide by the study requirements and visit the site for regular follow up.
排除标准
- •1 Volunteers with known allergies or sensitivities to cosmetic products or its components like fragrances, preservatives etc
- •2 Volunteers who are currently undergoing / had undergone dermatological treatments or procedures within the last 1 month
- •3 Volunteers with pre-existing or dormant dermatologic conditions (e.g. psoriasis, rosacea, rashes, eczema, many and/or severe excoriations etc.) that could interfere with the study outcome as determined by the investigator
- •4 Volunteers with an extremely high ( >4.5) or extremely low ( <2.5) malodor score as per the olfactory panel
- •5 Volunteers with wide difference in malodor scores across right and left axillae ( >1).
- •6 Volunteers with scars which could interfere with expert grading
- •7 Volunteers who are nursing or pregnant (Self declaration / Urine pregnancy test)
- •8 Volunteers unwilling to abstain from alcohol consumption and smoking for the study duration
- •9 Volunteers viewed by the investigator as not being able to complete the study
研究者
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