MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.

Study Overview
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Brief Summary
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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.

Official Title
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MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.

Conditions
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Solar Skin Damage

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin:Melatonincreme 12,5%<br>Application of melatonincream 12,5% on 80% of the body-surface at start of investigation. | Drug: Melatonin<br> <br> |
| Placebo Comparator: Placebo<br>Application of placebo cream on 80% of the body-surface at start of investigation. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive parameters, Melatonin, pharmacodynamic, pharmacokinetics