跳至主要内容
临床试验/CTRI/2018/02/011691
CTRI/2018/02/011691已完成Phase 3 4

To evaluate the moisturizing efficacy and thereby the ability to confer softness of the liquid hand wash in comparison with a benchmark on the skin of healthy human subjects.

Dabur India Ltd1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年3月31日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
入组人数
33
试验地点
1
主要终点
To evaluate the moisturzing effect of liquid hand wash on skin

研究概览

简要总结

Study was designed to test the moisturziation effect of test product on skin of healthy human subjects. 33 female subjects were enrolled in the study and all 33 subjects completed the study. The study was conducted over a period of 7 days for each subjects. The product need to use left and right forearm as per instruction and evaluation was done by instrument ( corneometer) and subject self assessment on each day. The results shows improvement in skin moisture content against benchmark. All the test products were deemed to be safe and given moisturization to skin.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Female subjects in generally good health.
  • Subjects in the age group of 18-40 years.
  • Subject has not used any moisturization soap or cream in one month.
  • Subject with dry skin in 30-40 Corneometer range.
  • Subject has not participated in a similar investigation in the past four weeks.
  • Subjects willing to give a written informed consent and come for regular follow up.

排除标准

  • A Known history or present condition of Allergic response to any cosmetic product particularly soap.
  • Subjects with active dermatological conditions that can involve the skin (eg.
  • Psoriasis, eczema, ichthyosis, tinea capitis, etc) other than the condition under study.
  • Chronic medication (e.g. antihistamines, antifungals, corticosteroids, topical steroids, etc.) that might influence the outcome of the study.
  • Subjects who are pregnant or nursing (as confirmed by Urine test for the determination of Pregnancy).

结局指标

主要结局

To evaluate the moisturzing effect of liquid hand wash on skin

时间窗: Day1, Day2, Day3 ,Day4 ,Day5

次要结局

  • Overall safety of the subject throughout the study(Day1, Day2, Day3 ,Day4 ,Day5)

研究者

申办方类型
Other [fmcg]

研究点 (1)

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