The Sun Protective Effect of Melatonin

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.

Study Overview

• Status: Completed
• Conditions: Sunburn
• Intervention / Treatment: Drug: Melatonin

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Gastroenheden, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Melatonin: Melatonin cream 2,5%; One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied	Drug: Melatonin
Active Comparator: Melatonin: Melatonin cream 0,5%; One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.	Drug: Melatonin
Active Comparator: Melatonin: Melatonin cream 12,5%; One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.	Drug: Melatonin
Placebo Comparator: placebo cream; One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied.
No Intervention: No treatment; One square on the back of each volunteers will be randomized to receive no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Cecilie Scheuer, Research Scholar, Gastroenheden, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 10, 2013

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Melatonin; Erythema; Sunlight; Sunburn; Ultraviolet rays
• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Burns; Photosensitivity Disorders; Sunburn; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 2013-000629-30