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

Zealand University Hospital

Status and phase: Completed; Phase 1

Conditions: Solar Skin Damage

Treatments: Drug: Placebo; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT02224937

2013-003023-10 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Melatonin:Melatonincreme 12,5%

Experimental group

Description:

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

Treatment:

Drug: Melatonin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo