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Completed

NCT Number: NCT02224937

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

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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Key information

Conditions

Solar Skin Damage

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Herlev Sygehus

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

Placebo

Drug

Primary outcomes

  1. Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. Changes in serum melatonin concentration

    Time frame: 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.

  4. Changes in saliva melatonin concentration.

    Time frame: 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.

  5. Changes in urine melatonin concentration

    Time frame: 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 outcomes

  1. Measurement changes in bloodpressure and puls.

    Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure

    Blood pressure and puls was monitored throughout the study.

  2. Holter monitoring

    Time frame: 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.

  3. Measurement of changes in body-temperature

    Time frame: 1,12,24 and 36 hours post exposure

    Body-temperature was monitored at 1,12,24 and 36 hours after cream application.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Aug 25, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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