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

Solar Skin Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224937
• Other study ID #: 2013-003023-10
• Secondary ID: 2013-003023-10
• Status: Completed
• Phase: Phase 1
• First received: August 20, 2014
• Last updated: November 13, 2014
• Start date: December 2013

Study information

• Verified date: November 2014
• Source: University Hospital Koge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: GCP, Copenhagen University
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Solar Skin Damage

Intervention

Drug:
• Melatonin

• Placebo

Locations

Country	Name	City	State
Denmark	Herlev Sygehus	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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.	No