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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003023-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin:Melatonincreme 12,5% | Experimental | Application of melatonincream 12,5% on 80% of the body-surface at start of investigation. |
|
| Placebo | Placebo Comparator | Application of placebo cream on 80% of the body-surface at start of investigation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area. | 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. | 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Continuous reaction time is a neuropsychological test designed to investigate endurance and attention by testing the persons ability to react to external stimuli over a given time period. This parameter is used to detect changes in endurance and attention over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body-surface area. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement changes in bloodpressure and puls. | Blood pressure and puls was monitored throughout the study. | 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure |
| Holter monitoring | Registration of alterations in heart rate throughout the time period of 0-36 hours will be continuously monitored using af Holter monitor. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilie Ms Scheuer, ph.d.student | Køge Sygehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Sygehus | Herlev | Herlev | 2730 | Denmark |
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|
| 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. | Finger tapping test is a simple way to investigate psychomotoric speed and control. Impaired psychomotoric speed is accepted as a predictor for cerebral dysfunction. This parameter is used to detect changes in psychomotoric speed and control over a time period of 36 hours after application of melatonincream 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 serum melatonin concentration | Blood samples are collected at the above mentioned time points. Serum melatonin is evaluated by laboratory tests. Blood samples are used to detect the changes in serum melatonin concentration 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 saliva melatonin concentration. | Saliva samples are collected at above mentioned time points. The concentration of melatonin in saliva is tested using laboratory analyses. Saliva samples are collected to detect changes in saliva melatonin concentration over a time period of 36 hours after application of melatonincream 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 | Urine is collected in the above mentioned time intervals, and the concentration of melatonin is found by measuring the concentration of the metabolite 6-sulfatoxymelatonin using RIA. The urine samples are collected and used to detect changes in 6-sulfatoxymelatonin concentration over a time period of 36 hours after application of melatonincream on 80% of the body surface area. | 0-4,4-8,8-12,12-24 and 24-36. |
| 1-36 hours |
| Measurement of changes in body-temperature | Body-temperature was monitored at 1,12,24 and 36 hours after cream application. | 1,12,24 and 36 hours post exposure |
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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