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.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers of both sexes. - 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: - Active skin disease - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Gastroenheden, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Visual inspection of erythema using Frosch-Klingman scale. | This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure | No | |
Primary | 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 | No |
Secondary | 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. | No |
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