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临床试验/CTRI/2019/03/018090
CTRI/2019/03/018090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

发起方
ITC Life Science and Technology Centre

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