The Sun Protective Effect of Melatonin

Sunburn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873430
• Other study ID #: 2013-000629-30
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2013
• Last updated: August 28, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sunburn

Intervention

Drug:
• Melatonin

Locations

Country	Name	City	State
Denmark	Gastroenheden, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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