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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01873430
Other study ID # 2013-000629-30
Secondary ID
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


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
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