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

NCT02224937 | Completed Phase 1 DMC

• 1 other identifier: 2013-003023-10
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Solar Skin Damage

Keywords

Melatonin; Cognitive parameters; pharmacodynamic; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (5)

• 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.

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

• 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.

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

• Changes in serum melatonin concentration

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

• Changes in saliva melatonin concentration.

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

• Changes in urine melatonin concentration

  0-4,4-8,8-12,12-24 and 24-36.

Other Outcomes (3)

• Measurement changes in bloodpressure and puls.

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

• Holter monitoring

  1-36 hours

• Measurement of changes in body-temperature

  1,12,24 and 36 hours post exposure

Study Arms (2)

Melatonin:Melatonincreme 12,5%

EXPERIMENTAL

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

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Melatonin DRUG

Melatonin:Melatonincreme 12,5%

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Active skin-disease
• Use of hypnotic or sedative drugs.
• Known sleeping disorder
• Known allergy to contents of the cream.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Herlev Sygehus

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Cecilie Ms Scheuer, ph.d.student

  Køge Sygehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ph.d.student

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 25, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2014
• Last Updated: November 17, 2014

Record last verified: 2014-11

Locations

DK (1)