Prospective, Double-Blinded, Randomized Placebo Controlled Study of an Oral Herbal Supplement on Photoaged Skin and Elasticity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Change in Skin Elasticity
研究概览
简要总结
The purpose of this study is to evaluate how an oral herbal supplementation influences facial skin elasticity and facial hydration as well as markers of photoaging (erythema and pigmentation).
详细描述
Skin is the largest organ of the body and skin aging represents a primary indicator of the aging process in the body. Photoaging is among the most crucial factors that cause skin aging damage. Photoaged skin is primarily induced by prolonged exposure to ultraviolet radiation leading to the appearance of increased skin pigmentation, reduced elasticity, and pronounced wrinkles. There has been an increasing recognition of the influence of nutrition on skin health with dietary elements emerging as a viable alternative approach to preventing photoaging. The aim of this study is to understand how oral supplementation impacts photoaged skin, facial hydration, and facial elasticity.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are 35 to 55 years of age
排除标准
- •Individuals who are pregnant or breastfeeding.
- •Prisoners.
- •Adults unable to consent.
- •Those who are unwilling to discontinue topical probiotics, topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
- •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 the 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.
- •Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- •Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
- •Any known allergy to any of the ingredients in the study product.
- •Those who have been on an oral antibiotic within 1 month prior enrolling
- •Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment
结局指标
主要结局
Change in Skin Elasticity
时间窗: 8 weeks
Skin elasticity measured with a handheld non-invasive device (Cutometer, Delfin Technologies Ltd.)
Change in Skin Hydration
时间窗: 8 weeks
The skin capacitance will be measured with a handheld non-invasive device (Skin MoistureMeterSC, Delfin Technologies Ltd.). The measurement is in arbitrary units per manufacturer.
次要结局
- Change in skin pigmentation intensity(8 weeks)
- Change in appearance of facial wrinkles(8 weeks)
- Change in the skin erythema(8 weeks)
- Change in skin transepidermal water loss(8 weeks)
- Self-perception of skin (changes in facial fine lines and wrinkles, firmness, etc)(8 weeks)
- Product Tolerability(8 weeks)