跳至主要内容
临床试验/CTRI/2024/04/066537
CTRI/2024/04/066537尚未招募Unknown

An in-Vivo Study to Determine the Sun Protection Factor of Mamaearth Vitamin C Daily Glow Sunscreen

Honasa Consumer Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Change in Individual MED (iMED) score

研究概览

简要总结

The below products would be tested as per the guidelineInternational Standard ISO 24444 and ISO 16217

Product Name Mamaearth Vitamin C Daily Glow Sunscreen

The study would be to estimate the SPF- sun protection factor

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18-70 years.
  • 2.Individual should have ITA angle in the range of 28-40, 41-55 and more than
  • 3.Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
  • 4.Individuals who have completed a preliminary medical history evaluation.
  • 5.Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
  • 6.Individuals with no known abnormal response to sunlight.

排除标准

  • 1.Individuals taking medication which in the opinion of the investigator would mask or interfere with the results.
  • 2.Individuals with chronic skin allergies.
  • 3.Individuals with suntan or sunburn.
  • 4.Individuals with abnormal reaction to the sun.
  • 5.Pregnant or lactating females.
  • 6.Subjects accustomed to using sun beds.
  • 7.Subjects who have participated in an SPF study within the last two months.

结局指标

主要结局

Change in Individual MED (iMED) score

时间窗: Day1, Day2

次要结局

  • Change in the redness of skin(Delayed Erythema Response)

研究者

发起方
Honasa Consumer Ltd.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Robin Chugh

CCFT Laboratories

研究点 (1)

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