Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Average Bruise Change
研究概览
简要总结
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-60
- •Subjects are in good health.
- •Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
排除标准
- •Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
- •Subjects who have a history of bleeding disorders.
- •Subjects who are unable to understand the protocol or to give informed consent
- •Subjects with mental illness
- •Subjects who are pregnant or nursing.
- •Subjects who have active systemic or local infection
- •Subjects with systemic or local skin disease.
- •Subjects with systemic illness.
研究组 & 干预措施
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
干预措施: Petrolatum United States Pharmacopeia (USP) (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
干预措施: Vitamin K and retinol ointment (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
干预措施: Arnica ointment (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
干预措施: Vitamin K ointment (Drug)
结局指标
主要结局
Average Bruise Change
时间窗: Baseline and 2 weeks
Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).
次要结局
未报告次要终点
研究者
Murad Alam
Associate Professor of Dermatology
Northwestern University