Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2013-05-31
2013-08-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
TRIPLE
Study Groups
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Melatonin: Melatonin cream 2,5%
One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied
Melatonin
Melatonin: Melatonin cream 0,5%
One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.
Melatonin
Melatonin: Melatonin cream 12,5%
One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.
Melatonin
placebo cream
One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied.
No interventions assigned to this group
No treatment
One square on the back of each volunteers will be randomized to receive no treatment.
No interventions assigned to this group
Interventions
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Melatonin
Eligibility Criteria
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Inclusion Criteria
* Skin type 1-3 according to Fitzpatrick skin type scale.
* No sun exposure on skin area tested in the study 4 weeks prior to the study.
Exclusion Criteria
* Participant that do not react to the given sun exposure with a change in a-value \>5 are excluded from the data.
* Pregnancy
* Previous malignant or pre malignant skin disease.
18 Years
90 Years
ALL
Yes
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Cecilie Scheuer
Research scholar, medical student
Principal Investigators
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Cecilie Scheuer, Research Scholar
Role: PRINCIPAL_INVESTIGATOR
Gastroenheden, Herlev Hospital
Locations
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Gastroenheden, Herlev Hospital
Herlev, Herlev, Denmark
Countries
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Other Identifiers
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2013-000629-30
Identifier Type: -
Identifier Source: org_study_id