Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Acetyl Zingerone With Teterahexyldecyl Ascorbate (THDA) Versus THDA Alone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Facial fine lines and wrinkles
研究概览
简要总结
The purpose of this study is to asses the impact of topically applying a form of vitamin C known as tetrahexyldecyl Ascorbate (THDA) along with a novel anti-aging ingredient, acetyl zingerone, compared against applying THDA alone.
详细描述
In this study, we examine the effects of adding acetyl zingerone to vitamin-C derived ester THDA on its effects on the signs of photoaging (redness, uneven skin tone, and the appearance of fine lines) and compare it to the effects of applying THDA alone.
Acetyl zingerone is derived from ginger and has anti-oxidant properties
In this study, participants will be randomized to either receiving a THDA + acetyl zingerone product or a THDA only product.
This means that you will have an equal chance of receiving either product. You and the research team will not know which product you have been randomized to received because the products will be labelled with a code. The research team will only know which product contained THDA + acetyl zingerone and which product contained only THDA at the end of the study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between the ages of 30 years old and 65 years old.
排除标准
- •Individuals who are pregnant or breastfeeding.
- •Prisoners.
- •Adults unable to consent.
- •Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- •Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.
- •Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.
- •Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
结局指标
主要结局
Facial fine lines and wrinkles
时间窗: 8 weeks
Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)
Facial skin pigment evenness
时间窗: 8 weeks
Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)
次要结局
- Facial fine lines and wrinkles(4 weeks)
- Facial skin pigment evenness(4 weeks)
- Skin redness(8 weeks)
- Change in skin pigmentation in the undereye area(8 weeks)
- Self-perception of skin parameters(8 weeks)
- Tolerability of product(8 weeks)