An Innovative Proof-of-concept Approach to Identify Age-modulating Drugs Capable of Reversing Inflammation and Re-setting the Epigenetic Clock (Topical-RAPA)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in Epigenetic Markers
研究概览
简要总结
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
详细描述
Rapamycin 8% ointment will be applied topically to one of the participant's forearms and matching placebo to the opposite forearm daily for a total of 6 months. After consenting, screening and randomization of arms, the participants will be monitored at monthly visits until study completion.
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)
盲法说明
Randomization will be performed by the compounding pharmacy. Ointment dispensers will be color-coded for left and right arm for each subject.
入排标准
- 年龄范围
- 65 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65-95 years of age.
- •Good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
- •Selected subjects will be in good health (Per the World Health Organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity).
- •All diseases or infirmities will be clinically stable whether managed by medications or not.
- •CLOX score of 10 or greater
- •Women will be postmenopausal
- •Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months
- •Live within a 20 mile drive of the UTHSA campus (7703 Floyd Curl Drive, San Antonio, TX)
排除标准
- •Diabetes.
- •History of skin ulcers or poor wound healing, or keloid formers.
- •Liver disease.
- •Coumadin anti-coagulation.
- •Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc. - due to role in rapamycin metabolism).
- •Treatment with an immunosuppressant (prednisone, etc.) within 6 months.
- •History of recent (within 6 months) Myocardial Infarction or active Coronary Disease.
- •Hypersensitivity to rapamycin or petrolatum (ointment vehicle)
- •Arm tattoos or scars in application area
研究组 & 干预措施
Topical Rapamycin
Ointment is applied to a color coded area on the subject forearm daily.
干预措施: Rapamycin Topical Ointment (Drug)
Placebo
Placebo ointment is applied to a color coded area on the subject forearm daily.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Epigenetic Markers
时间窗: Baseline to 6 months
A set of DNA methylation marks that correlate with chronological age will be used to measure rejuvenation of the "epigenetic clock" due to drug treatment compared to placebo. Using Illumina EPIC arrays, CpG methylation will be assessed and then the predicted age, based on the combined methylation at the set of 391 marks (the "epigenetic clock" as defined by Dr. Steven Horvath, UCLA), will be determined.
次要结局
- Change in Inflammatory Marker IL-6(Baseline to 6 months)
- Change in Inflammatory Marker CRP(Baseline to 6 months)
研究者
Ellen Kraig
Prof & Deputy Chair of Faculty Development Cell Systems & Anatomy
The University of Texas Health Science Center at San Antonio