CompletedPhase 1

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

Denmark10 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

Trial details

NCT IDNCT02224937

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

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