Finasteride and Cutibacterium
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Cutibacterium skin load
研究概览
简要总结
High levels of Testosterone causes high amounts of skin bacteria (Cutibacterium Acnes) which can go into the skin during a shoulder replacement surgery and cause a terrible infection.
The goal of this experiment is to have participants take Finasteride, a medication that blocks testosterone production, for 2 weeks and evaluate the following:
- Blood levels of testosterone
- Amount of bacteria on the skin.
Participants will:
- Be assigned to take Finasteride, or a placebo (a look-alike pill with no active medicine) once daily, for 2 weeks
- Have a small sample of their blood collected and their skin swabbed with a Q-tip to determine Testosterone levels and bacteria on the skin
- Blood draw and skin testing will take place before starting Finasteride or the placebo (day 0) and at the end of the experiment (day 14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Inclusion We will include the group most impacted by PJI
- •Adult males
- •Age between 18 and 65 Exclusion
- •History of cryptorchidism, hypospadias, or other congenital abnormality of male reproductive tract
- •Female sex
- •Age younger than 18 or older than 65
- •Current use of Finasteride or other 5-alpha reductase inhibitors
- •Current use of hormone replacement medications such as testosterone
- •Recent antibiotic use within 3 months
- •Have had a negative reaction to oral Finasteride before
- •Recent use of acne treatment within 3 months
- •Self-report very sensitive skin
- •Allergic to chlorhexidine or isopropyl alcohol
- •Have open wounds on both shoulders
排除标准
- 未提供
结局指标
主要结局
Cutibacterium skin load
时间窗: Skin load will be assessed at day 0 and at the end of the study on day 14 of treatment or placebo.
Skin load will be determined using bacterial culture of the skin and assigning a value based on the report from the microbiology lab: 0 for "no growth"; 0.1 for "growth of 1 colony only" or for "growth in broth only"; and 1, 2, 3 and 4 for 1+, 2+, 3+ and 4+ growth, respectively. Mann-Whitney U test will be used to compare the change in the semi-quantitative skin load at baseline and day 14 in the intervention and control group, along with comparison of the percentage of subjects in each group that began with a high baseline skin load (\>2) and ended with a low skin load (≤1).
Serum Dihydrotestosterone (DHT) Level
时间窗: levels will be assessed at baseline and after 14 consecutive days of treatment or placebo.
Participants blood will be collected and processed for serum DHT level by the certified and state-licensed phlebotomists and clinical laboratory technicians at our intuition, which is in the same building as the outpatient clinic.
次要结局
未报告次要终点
研究者
Corey Schiffman
Assistant Professor: School of Medicine, Orthopaedics and Sports Medicine
University of Washington