Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Erythema on SkinColorCatch
研究概览
简要总结
Recent research has reported that the maple leaf extract exhibits anti-aging effects by inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering with the formation of wrinkles. Red maple leaf extract contains phenolic compounds known as glucitol-core-containing gallotannins (GCGs) which help reduce the appearance of wrinkles and may decrease skin inflammation, dark spots and pigmentation. The objective of this study is to examine the effects of topical Maplifa on the cosmetic appearance of facial lines, redness and skin tone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged 30-70
- •Individuals with Fitzpatrick skin type I-IV
排除标准
- •Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator
- •Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
- •Individuals who have participated in any other clinical studies using the same test sites (face) and hand in the past 14 days
- •Individuals who are pregnant, breast feeding or planning a pregnancy within one month. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation).
- •Female volunteers who have started a new hormonal birth control agent or had a change in their hormonal birth control agent within the past 60 days
- •Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
- •Individuals who are currently using or during the past 30 days have used a retinoid such as Retin A, or other Rx/OTC Retinyl A or currently using or during the past 14 days have used hydroquinone (skin lightening)
- •Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
- •Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
研究组 & 干预措施
vehicle only-placebo
Vehicle cream base containing no maple leaf extract to be applied twice daily to the face
干预措施: vehicle (Combination Product)
1% red maple leaf extract
lotion preparation with 1% red maple leaf extract to be applied twice daily to the face
干预措施: 1% red maple leaf extract in cream base (Combination Product)
5% red maple leaf extract
lotion preparation with 5% red maple leaf extract to be applied twice daily to the face
干预措施: 5% red maple leaf extract (Combination Product)
结局指标
主要结局
Erythema on SkinColorCatch
时间窗: At 4 weeks (end of study)
Assessment of erythema based on SkinColorCatch (arbitrary units set by technology)
Clinical grading of Erythema
时间窗: At 4 weeks (end of study)
Assessment of erythema based on clinical grading (categories 0-5) by blinded evaluator
Pigmentation on SkinColorCatch
时间窗: At 4 weeks (end of study)
Assessment of pigmentation based on melanin measurement on SkinColorCatch (arbitrary units set by technology)
Clinical grading of Hyperpigmentation
时间窗: At 4 weeks (end of study)
Assessment of hyperpigmentation based on clinical grading (categories 0-5) by blinded evaluator
次要结局
- Centrofacial redness(At 4 weeks (end of study))
- Appearance of wrinkles(At 4 weeks (end of study))