A Single Center, Randomized, Evaluator Blinded Clinical Study to Evaluate the Effect of a Topical Retinol on Epigenetic Changes and Expression of Certain Genes in the Skin Using Non-invasive Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Skin tape stripping.
研究概览
简要总结
This study is being conducted to confirm whether skin tape stripping methodology can identify changes in gene expression (i.e. whether different genes are turned on to make proteins) in aged skin after use of a retinoid.
详细描述
This is a randomized study. Participants will be randomly assigned to either the intervention cell and receive a cleanser, a sunscreen serum, and a night cream or the control cell and receive a cleanser and a sunscreen serum to use at home for 10 weeks. Participants will be randomized and receive products at Visit 1 (Screening/Baseline) conducted at Day 0 and return to the clinical site at Day 28 for Visit 2, and at Day 71 for Visit 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Has clinically determined moderate photodamage (defined as a score of 4 - 6 on a 0- 9-point scale) on the face at Visit
- •Is able to read, write, speak, and understand English.
- •Generally in good health.
- •Intends to complete the study and is willing and able to follow all study instructions.
排除标准
- •Has known allergies or negative reactions to common topical skincare products, adhesives, latex, or ingredients in the study products.
- •Has clinically active bacterial, fungi, or viral skin infection or has frequent skin infections.
- •Presents with a skin condition that may increase risk to the subject, influence study results, or interfere with study evaluations (e.g. acne, psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, active skin cancer, tattoos, scarring, scratches/broken skin, sunburn, excessive hair growth, or very uneven skin tone) as determined by the principal investigator (PI).
- •Has self-perceived sensitive skin.
- •Is a regular (occasional to daily) smoker of cigarettes or user of electronic cigarettes (vaping pens).
- •Is a regular (occasional or frequent) user of tanning beds and/or self-tanning products.
- •Has had a surgical or aesthetic procedure in the last 3 months that can affect facial wrinkles or facial pigmentation (e.g. botulinum toxin (Botox) injections, chemical peels, laser-based therapies to the face, or face lift surgery).
- •Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti- diabetic medication.
- •Is taking a medication that could mask a negative reaction or influence study results, as determined by the PI.
- •Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study.
- •Has a history of or a current health/other condition/situation which may put the individual at significant risk, influence the study results, or interfere significantly with the individual's participation in the study.
- •Is currently participating in any other clinical study or has participated in any product-use study within 30 days prior to the study visit.
- •Is an employee/contractor or immediate family member of the PI, study site, or Sponsor.
结局指标
主要结局
Skin tape stripping.
时间窗: Baseline (Day 0), Visit 3 (Day 71)
The investigator will collect skin samples from subjects through a non-invasive method - tape stripping. The tape strips will be analyzed by extracting DNA collected from the epidermal skin cells then use targeted sequencing using 4M CpG sites to further analyze if certain genes (assessment of UV damage, smoking, and biological age ) are turned on or off from retinol use. Baseline samples will be compared to Day 71 samples.
次要结局
未报告次要终点