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The Sun Protective Effect of Melatonin

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ClinicalTrials.gov Identifier: NCT01873430
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Cecilie Scheuer, Herlev Hospital

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date August 29, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2013)
Testing for primary hyperalgesia in the sun exposed area with Pin-Prick monofilaments. Testing for primary hyperalgesi in the sunexposed area with Pin-Prick monofilaments. [ Time Frame: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure. ]
Current Other Pre-specified Outcome Measures
 (submitted: June 7, 2013)
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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Sun Protective Effect of Melatonin
Official Title  ICMJE The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Sunburn
Intervention  ICMJE Drug: Melatonin
Study Arms  ICMJE
  • 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
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2013)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873430
Other Study ID Numbers  ICMJE 2013-000629-30
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cecilie Scheuer, Herlev Hospital
Study Sponsor  ICMJE Herlev Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecilie Scheuer, Research Scholar Gastroenheden, Herlev Hospital
PRS Account Herlev Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP