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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. completion date
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


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
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