Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in Keloid Surface Area
研究概览
简要总结
- To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months)
- To test safety of product and feasibility of conduct for future clinical trial
详细描述
This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses.
Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37).
Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
- •Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
- •Cognitive functioning sufficient to provide informed consent
- •Physically able to apply ointment to keloids daily
- •Able to attend monthly clinic visits for 6 months
排除标准
- •Diagnosis of diabetes
- •Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
- •Local area steroidal treatment within the past 3 months
- •History of allergy to rapamycin of petrolatum-based products
研究组 & 干预措施
RAPA intervention
Rapamycin ointment will be applied to one keloid on the subject
干预措施: Rapamycin 8% Ointment (Drug)
Placebo
Placebo will be applied as a control on one keloid on the subject
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Keloid Surface Area
时间窗: Baseline to 6 months
Measurement of surface area of keloid
次要结局
- Change in Keloid Height(Baseline to 6 months)