NCT05756881终止不适用
A Randomised Double-blind Placebo-controlled Study on the Effects of Topical Palm Tocotrienols on Blemish-prone Skin
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline
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 12-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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals, aged 18 years and above
- •Fitzpatrick skin type II to IV
- •Blemish-prone skin with acne of severity grade 2 or 3 based on Comprehensive Acne Severity Scale (CASS)
排除标准
- •Has a history of chronic drug or alcohol abuse
- •Is a current smoker
- •History of severe allergic reactions to topical products or vitamin E
- •Participant with severe and uncontrollable 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 (such as polycystic ovary syndrome and contact dermatitis)
- •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
- •Has severe acne or acne conglobata
- •Use of systemic treatment for acne such as isotretinoin, contraceptive pills, or spironolactone within 4 weeks of screening visit
- •Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, salicylic acid, alpha hydroxy acids (AHAs), vitamins A (retinol) or C (ascorbic acid) or their analogs or derivatives and other anti-inflammatory drugs within 2 weeks of screening visit
- •Use of scrub, alpha-hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start
- •Participant with active bacterial/fungal/viral skin infections or susceptibility to such infections within 2 weeks of Screening visit
- •Use oral antibiotics
研究组 & 干预措施
Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate
Active Comparator
Serum containing 1.5 % w/w of palm-oil derived vitamin E concentrate
干预措施: Cosmetic product (Other)
Serum (placebo)
Placebo Comparator
Serum (placebo)
干预措施: Cosmetic product (Other)
结局指标
主要结局
Proportion of participants with at least 50% reduction in numbers of acne lesion or at least 2 grade improvement according to CASS from baseline
时间窗: 18 Week
Acne lesion count
次要结局
- CASS assessment(18 Week)
- The percent change from baseline in global face total lesion count.(18 Week)
- Acne lesion counts for the total global face and total lesion counts(18 Week)
- Survey (CADI)(18 Week)
- The percent change from baseline in sebum, skin pH, hydration and erythema index(18 Week)
研究者
Goh Choon Fu
Principal Investigator
Universiti Sains Malaysia
研究点 (1)
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