NCT05787743终止不适用
A Randomised Double-blinded Placebo Controlled Study on the Effect of Topical Palm Tocotrienol on Skin Biophysical Properties
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Percent change from baseline in wrinkle (SEw)
研究概览
简要总结
A single-center, double-blind, randomised, placebo-controlled parallel-group study.
Selected subjects will be randomised into active and control groups in a ratio of 1:1. Investigational products assigned will be applied on the facial skin as part of daily skin care routine. The effects will be observed during the 24-weeks of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female individuals, aged 25 - 45 years old, inclusive
- •Fitzpatrick skin type II to IV
- •In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject.
- •Willing to provide informed consent and comply with study procedures
排除标准
- •Has a history of chronic drug or alcohol abuse
- •Is current smoker
- •History of severe allergic reactions to topical products or vitamin E
- •Participant with severe and uncontrolled comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure)
- •Pregnant, breastfeeding, or planning pregnancy
- •Participant with known skin conditions (including but not limited to e.g. sensitive skin, eczema and diseased skin e.g. contact dermatitis), uncontrolled medical conditions, or any other condition that could interfere with the study evaluations or increase risk to the participant
- •Participant with compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk
- •Participation in another study within 4 weeks of screening visit
结局指标
主要结局
Percent change from baseline in wrinkle (SEw)
时间窗: 24 week
Wrinkle
次要结局
- Percent change from baseline for Lemperle Wrinkle Assessment Scale(24 week)
- Percent change from baseline in scores of survey (BeautyQoL)(24 week)
- Percent change from baseline in roughness (SEr), scaliness(SEsc), smoothness (SEsm), TEWL, Young's modulus, viscoelasticity, retraction time, collagen content, skin thickness, pigmentation index, erythema index, skin colour, pH, sebum and hydration(24 week)
研究者
Goh Choon Fu
Principal Investigator
Universiti Sains Malaysia
研究点 (2)
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