Status:
COMPLETED
MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
Lead Sponsor:
Zealand University Hospital
Conditions:
Solar Skin Damage
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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, uri...
Eligibility Criteria
Inclusion
- 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
- Pregnancy
- Active skin-disease
- Use of hypnotic or sedative drugs.
- Known sleeping disorder
- Known allergy to contents of the cream.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02224937
Start Date
December 1 2013
Last Update
November 17 2014
Active Locations (1)
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1
Herlev Sygehus
Herlev, Herlev, Denmark, 2730