Clinical Trial: The Sun Protective Effect of Melatonin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Herlev Hospital

Current Primary Outcome: Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure. [ Time Frame: Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure ]

The alpha value measured in a "color space converted" image will represent the degree of erythema


Original Primary Outcome: Same as current

Current Secondary Outcome: Testing for primary hyperalgesia in the sun exposed area with Pin-Prick monofilaments. Testing for primary hyperalgesia in the sun-exposed area with Pin-Prick monofilaments. [ Time Frame: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure. ]

Original Secondary Outcome: Testing for primary hyperalgesia in the sun exposed area with Pin-Prick monofilaments. Testing for primary hyperalgesi in the sunexposed area with Pin-Prick monofilaments. [ Time Frame: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure. ]

Information By: Herlev Hospital

Dates:
Date Received: June 6, 2013
Date Started: May 2013
Date Completion:
Last Updated: August 28, 2013
Last Verified: August 2013