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临床试验/NCT05657379
NCT05657379已完成不适用

The Effect of Product X Moisturizer on Skin Texture of Middle-Aged Women in Malaysia

Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X

研究概览

简要总结

The goal of this clinical trial is to evaluate the effect of Product X on facial skin of middle-aged women in Malaysia. The main questions it aims to answer are:

  1. The effect of Product X on skin hydration of middle-aged women in Malaysia.
  2. The effect of Product X on skin elasticity of middle-aged women in Malaysia.
  3. The effect of Product X on skin wrinkle of middle-aged women in Malaysia.
  4. To observe any adverse effect occurrence with the use of Product X.

Participants will used Product X for 8 week and the skin assessment will be carried out at baseline, week 2, 4 and week 8.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Malaysian citizen
  • Middle-aged woman (40-60 years old)

排除标准

  • Participants taking isotretinoin
  • Immunocompromised patients or participants with any skin diseases or diseases that may compromised the participants well-being and study outcome.
  • Participant who undergo any cosmetic procedures such as laser & light treatment for the past three months.
  • Participant with a history of facial surgery.

结局指标

主要结局

Change in skin elasticity from baseline and at week 2, 4 and 8 after using Product X

时间窗: Baseline, week 2, 4 and 8

Skin elasticity will be assessed using JANUS III skin analyzer

Adverse effect after using Product X

时间窗: Week 8

Based on adverse effect occurrence on participants that occur during study period (8 weeks)

Change in skin hydration from baseline and at week 2, 4 and 8 after using Product X

时间窗: Baseline, week 2, 4 and 8

Skin hydration will be assessed using JANUS III skin analyzer

Change in skin wrinkles from baseline and at week 2, 4 and 8 after using Product X

时间窗: Baseline, week 2, 4 and 8

Skin wrinkles will be assessed using JANUS III skin analyzer and Wrinkle Severity Rating Scale (WSRS). For WSRS, dermatologists will evaluate participants' wrinkles based on 5-point photonumeric rating scale that will objectively evaluate the severity of crow's feet at rest (static) and with a smiling expression (dynamic). The scale scores are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.

次要结局

未报告次要终点

研究者

发起方
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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