A Phase 1 interventional study of Melatonin in Sunburn, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-29.
Sponsored by Herlev Hospital · Phase 1, Interventional, and Prevention
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.
29 studies on the registry are indexed under Sunburn; 2 are open to participants now.
This study's enrollment of 22 is below the median of 54 across 26 interventional studies indexed under Sunburn.
Browse Sunburn studies →Herlev Hospital is the lead sponsor of 201 studies on the registry; 24 are open to participants now.
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One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied
Drug: Melatonin
One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.
Drug: Melatonin
One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.
Drug: Melatonin
One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied.
One square on the back of each volunteers will be randomized to receive no treatment.
Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.
The alpha value measured in a "color space converted" image will represent the degree of erythema
Time frame: Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure
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.
Visual inspection of erythema using Frosch-Klingman scale.
Time frame: This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure
The record gives a start of May 2013, a primary completion of May 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin