Sunburn Clinical Trial
Official title:
The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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