Clinical trial NCT01873430: The Sun Protective Effect of Melatonin
Official title: The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sunburn
Keywords: Melatonin
Sunburn
Erythema
Sunlight
Ultraviolet rays
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.
timeFrame: Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure
Secondary outcomes:
measure: 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.
timeFrame: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure.
Other outcomes:
measure: Visual inspection of erythema using Frosch-Klingman scale.
timeFrame: This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure
Locations:
city: Herlev
country: Denmark
facility: Gastroenheden, Herlev Hospital
Study officials:
affiliation: Gastroenheden, Herlev Hospital
name: Cecilie Scheuer, Research Scholar
role: PRINCIPAL_INVESTIGATOR
References: