The Sun Protective Effect of Melatonin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cecilie Scheuer, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01873430
First received: June 6, 2013
Last updated: August 28, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cecilie Scheuer, Research scholar, medical student, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01873430     History of Changes
Other Study ID Numbers: 2013-000629-30
Study First Received: June 6, 2013
Last Updated: August 28, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on July 28, 2014