MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Melatonin:Melatonincreme 12,5% Application of melatonincream 12,5% on 80% of the body-surface at start of investigation. |
Drug: Melatonin
|
| Placebo Comparator: Placebo Application of placebo cream on 80% of the body-surface at start of investigation. |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Changes in Karolinska Sleepiness Scale 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.]
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.
Secondary Outcome Measures
- 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.]
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.
- 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.]
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.
- Changes in serum melatonin concentration [1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.]
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.
- Changes in saliva melatonin concentration. [1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure]
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.
- Changes in urine melatonin concentration [0-4,4-8,8-12,12-24 and 24-36.]
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.
Other Outcome Measures
- Measurement changes in bloodpressure and puls. [1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure]
Blood pressure and puls was monitored throughout the study.
- Holter monitoring [1-36 hours]
Registration of alterations in heart rate throughout the time period of 0-36 hours will be continuously monitored using af Holter monitor.
- Measurement of changes in body-temperature [1,12,24 and 36 hours post exposure]
Body-temperature was monitored at 1,12,24 and 36 hours after cream application.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Pregnancy
-
Active skin-disease
-
Use of hypnotic or sedative drugs.
-
Known sleeping disorder
-
Known allergy to contents of the cream.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Sygehus | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Zealand University Hospital
Investigators
- Principal Investigator: Cecilie Ms Scheuer, ph.d.student, Køge Sygehus
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013-003023-10
- 2013-003023-10