A Phase I Study of Topical Myristyl Nicotinate Cream on Human Skin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Participants With Adverse Events by Treatment.
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming.
PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.
详细描述
OBJECTIVES:
- To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers.
- To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period.
OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls.
- Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks.
- Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 18 years of age or older with normal skin
- •Have used no topical medications on the skin of the upper extremities, except for emollients or sunscreens, for at least 30 days prior to study entry
- •Agree to limit sun exposure as much as possible and wear protective clothing on the forearms in place of using sunscreens or moisturizers
- •Ability to understand and willingness to sign an informed consent before initiation of therapy after the nature of the study has been explained to them
- •Females must be surgically sterile by hysterectomy or post menopausal
排除标准
- •Subjects with no signs of inflammation or irritation of the skin on the forearms
- •Subjects with prior history of actinic keratosis or skin cancer on the forearm
- •Females of child bearing potential
- •Subjects with any concurrent therapy (e.g., retinoids, fluorouracil) on the forearms that may interfere with clinical evaluations
- •Subjects taking oral supplemental niacin, by itself or in the form of a multi-vitamin that exceeds 40 mg/day
- •No known immunosuppression by virtue of medication or disease, including AIDS patients, subjects taking oral prednisone, and subjects on immunosuppressants/immunomodulators( cyclosporine, chemotherapeutic agents, or biologic therapy), determined by the examining investigator/co-investigator
- •Uncontrolled intercurrent illness including, but not limited to any of ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Subjects who have had invasive cancer within the past 5 years
- •Skin conditions felt by the study physician to contraindicate enrollment including, but not limited to, psoriasis or atopic dermatitis within a proposed treatment area
- •Less than 30 days since prior and no concurrent or planned participation in another clinical trial
研究组 & 干预措施
Myristyl (right), Placebo (Left)
Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo
干预措施: Topical Myristyl Nicotinate Cream (Drug)
Myristyl (right), Placebo (Left)
Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo
干预措施: Placebo (Drug)
Myristyl (Left), Placebo (Right)
Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
干预措施: Topical Myristyl Nicotinate Cream (Drug)
Myristyl (Left), Placebo (Right)
Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Participants With Adverse Events by Treatment.
时间窗: 30 Days
Comparison of number of participants with adverse events by treatment.
次要结局
未报告次要终点