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临床试验/CTRI/2025/02/079913
CTRI/2025/02/079913已完成Unknown

An In-Vivo Study to Determine the Sun Protection Factor of TDC 1 Percentage Hyaluronic Sunscreen Oil Free Gel

Honasa Consumer Limited1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年2月14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 Individual MED (iMED) score

研究概览

简要总结

This is the In-vivo SPF test done as per ISO 24444 to determine the Sun Protection Factor

Test Product:

TDC 1% Hyaluronic Sunscreen oil free Gel

Done on 10 human volunteers. Duration: 3Days

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Individual should have ITA angle in the range of 18 t0 40, 41 to 55, and greater than 56
  • Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the investigator.
  • Individuals who have completed a preliminary medical history evaluation.
  • Individuals who have read, understood and signed an informed consent document relating to the specific study to which they are subscribing.
  • 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 Limited
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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