NCT01873430

The Sun Protective Effect of Melatonin

The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the sun protective effect of melatonin, when used as a cream applied before sun exposure. Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is proven that the amount of free radicals in the skin are increased by UV exposure. Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that melatonin can be protective against the UV induced release of free radicals by acting as a radical scavenger and thereby protect against UV-induced cellular damage.

Detailed description

This study investigates the sun protective effect of melatonin when used as a creme applied before sun exposure. The study is a randomized, placebo-controlled, double-blinded study conducted on healthy volunteers. The volunteers will have 5 squares of 8 cm\*8 cm on their backs, which each will be randomized to receive one of following: melatonin cream 0,5%; melatonin cream 2,5%; melatonin cream 12,5%; placebo cream (vehicle) and no treatment. After randomization and received treatment the volunteers will be exposed to strong midday sun (UV-index of approximately 9) for 40 minutes. The outcomes parameters (degree of erythema and pain sensation) are measured at baseline and 1,4,8 and 24 hours post exposure.

Conditions

• Sunburn

Interventions

Type	Name	Description
DRUG	Melatonin

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2013-06-10
• Last updated: 2013-08-29

Locations

1 site across 1 country: Denmark