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.

Study Overview

• Status: Completed
• Conditions: Solar Skin Damage
• Intervention / Treatment: Drug: Placebo; Drug: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Cecilie Ms Scheuer, ph.d.student, Køge Sygehus

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: August 20, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (ESTIMATE): August 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Melatonin; pharmacokinetics; pharmacodynamic; Cognitive parameters
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 2013-003023-10 (EUDRACT_NUMBER)