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Completed

NCT Number: NCT01873430

The Sun Protective Effect of Melatonin

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.

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Key information

Conditions

Sunburn Burns Erythema Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Gastroenheden, Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin

Drug

Primary outcomes

  1. Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.

    Time frame: Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure

    The alpha value measured in a "color space converted" image will represent the degree of erythema

Secondary outcomes

  1. 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.

    Time frame: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure.

Other outcomes

  1. Visual inspection of erythema using Frosch-Klingman scale.

    Time frame: This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 10, 2013
Registry last updated
Aug 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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