MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.
研究概览
简要总结
The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application. Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers of both sexes
- •Age 18-65 years
- •No shiftwork
- •No intake of caffeine or alcohol one day before investigation, and under the experiment.
- •Pittsburgh sleep quality index <5
- •Height 165-190 cm
- •Weight 53-85 kg
排除标准
- •Pregnancy
- •Active skin-disease
- •Use of hypnotic or sedative drugs.
- •Known sleeping disorder
- •Known allergy to contents of the cream.
研究组 & 干预措施
Melatonin:Melatonincreme 12,5%
Application of melatonincream 12,5% on 80% of the body-surface at start of investigation.
干预措施: Melatonin (Drug)
Placebo
Application of placebo cream on 80% of the body-surface at start of investigation.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.
时间窗: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Karolinska sleepiness scale is a valid scale for measurement of subjective sleepiness in individuals. This scale is used to detect any changes in subjective sleepiness over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body-surface area.
次要结局
- Changes in continuous reaction time over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.(1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.)
- Changes in finger tapping test over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.(1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.)
- Changes in urine melatonin concentration(0-4,4-8,8-12,12-24 and 24-36.)
- Changes in saliva melatonin concentration.(1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure)
- Changes in serum melatonin concentration(1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.)
研究者
Cecilie Scheuer
ph.d.student
Zealand University Hospital