The Sun Protective Effect of Melatonin

Herlev Hospital

Status and phase: Completed; Phase 1

Conditions: Sunburn

Treatments: Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01873430

2013-000629-30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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22 participants in 5 patient groups, including a placebo group

Melatonin: Melatonin cream 2,5%

Active Comparator group

Description:

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied

Treatment:

Drug: Melatonin

Melatonin: Melatonin cream 0,5%

Active Comparator group

Description:

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.

Treatment:

Drug: Melatonin

Melatonin: Melatonin cream 12,5%

Active Comparator group

Description:

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.

Treatment:

Drug: Melatonin

placebo cream

Placebo Comparator group

Description:

One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied.

No treatment

No Intervention group

Description:

One square on the back of each volunteers will be randomized to receive no treatment.