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

NCT ID: NCT02224937

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solar Skin Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Melatonin:Melatonincreme 12,5%

Application of melatonincream 12,5% on 80% of the body-surface at start of investigation.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Placebo

Application of placebo cream on 80% of the body-surface at start of investigation.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Melatonin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cecilie Scheuer

ph.d.student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cecilie Ms Scheuer, ph.d.student

Role: PRINCIPAL_INVESTIGATOR

Køge Sygehus

Locations

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Herlev Sygehus

Herlev, Herlev, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2013-003023-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013-003023-10

Identifier Type: -

Identifier Source: org_study_id