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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin: Melatonin cream 2,5% | Active Comparator | One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied |
|
| Melatonin: Melatonin cream 0,5% | Active Comparator | One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied. |
|
| Melatonin: Melatonin cream 12,5% | Active Comparator | One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied. |
|
| placebo cream | Placebo Comparator | One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied. | |
| No treatment | No Intervention | One square on the back of each volunteers will be randomized to receive no treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual inspection of erythema using Frosch-Klingman scale. | This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilie Scheuer, Research Scholar | Gastroenheden, Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenheden, Herlev Hospital | Herlev | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D013471 | Sunburn |
| D004890 | Erythema |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002056 | Burns |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D014947 |
| Wounds and Injuries |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |