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The Sun Protective Effect of Melatonin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01873430
First Posted: June 10, 2013
Last Update Posted: August 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cecilie Scheuer, Herlev Hospital
  Purpose

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.


Condition Intervention Phase
Sunburn Drug: Melatonin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Cecilie Scheuer, Herlev Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873430


Locations
Denmark
Gastroenheden, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Cecilie Scheuer, Research Scholar Gastroenheden, Herlev Hospital
  More Information

Responsible Party: Cecilie Scheuer, Research scholar, medical student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01873430     History of Changes
Other Study ID Numbers: 2013-000629-30
First Submitted: June 6, 2013
First Posted: June 10, 2013
Last Update Posted: August 29, 2013
Last Verified: August 2013

Keywords provided by Cecilie Scheuer, Herlev Hospital:
Melatonin
Sunburn
Erythema
Sunlight
Ultraviolet rays

Additional relevant MeSH terms:
Sunburn
Photosensitivity Disorders
Skin Diseases
Burns
Wounds and Injuries
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants