Prospective Randomized Vehicle-Controlled Double-Blind Assessment of the Effects of Zinc Di-(Dibutyryl Lisinate) on Skin Biophysical Properties and the Skin Microbiome in Photoaged Skin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Skin Hydration
研究概览
简要总结
This study is a double-blind randomized vehicle-controlled study assessing how Zinc Di-(dibutyryl lisinate) (Z-DBL) influences skin biophysical measures such as skin hydration, transepidermal water loss, and elasticity, as well as its effects on the skin microbiome of photoaged skin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between the ages of 40 years of age until 60 years of age
- •Participants must have facial fine lines and wrinkles
- •Subjects must minimize sun exposure
- •Subjects must avoid professional or facial spa procedures during the study
排除标准
- •Individuals who are pregnant or breastfeeding.
- •Prisoners.
- •Adults unable to consent.
- •Those who are unwilling to discontinue topical hydroquinone, retinoids, bakuchiol, vitamin C, or acetyl zingerone containing products for two weeks to meet the washout criteria prior to enrolling.
- •Those who are unwilling to discontinue topical antibiotics and benzoyl peroxide for two weeks to meet the washout criteria prior to enrolling.
- •Those who have been on an oral antibiotic within 1 month 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.
- •Those who are unwilling to discontinue all facial topical products except the product provided in the study.
- •Individuals who have changed any of their hormonal based contraception within
- •months prior to joining the study.
- •Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
结局指标
主要结局
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.
Change in image analysis based pigment intensity
时间窗: 8 weeks
Facial photographs will be analyzed for pigment intensity for the face after the photographs are obtained and analyzed utilizing the BTBP 3D Clarity Pro Facial Modeling and Analysis System (Brigh-Tex BioPhotonics, San Jose, CA, USA). The pigment intensity will be measured as a relative change from baseline and is a dimensionless and normalized measure.
次要结局
- Shifts in the skin microbiome diversity(8 weeks)
- Change in skin transepidermal water loss(8 weeks)
- Changes in skin barrier biomarkers like filaggrin(8 weeks)
- Change in image analysis based wrinkle severity(8 weeks)
- Product tolerability(8 weeks)
- Change in skin elasticity(8 weeks)