The Sun Protective Effect of Melatonin

NCT01873430 | Completed Phase 1

• 1 other identifier: 2013-000629-30
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Sunburn

Keywords

Melatonin; Sunburn; Erythema; Sunlight; Ultraviolet rays

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Visual inspection of erythema using Frosch-Klingman scale.

  This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure

Study Arms (5)

Melatonin: Melatonin cream 2,5%

ACTIVE COMPARATOR

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied

Drug: Melatonin

Melatonin: Melatonin cream 0,5%

ACTIVE COMPARATOR

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.

Drug: Melatonin

Melatonin: Melatonin cream 12,5%

ACTIVE COMPARATOR

One square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied.

Drug: Melatonin

placebo cream

PLACEBO COMPARATOR

One square on the back of each volunteers will be randomized to have placebo cream (vehicle) applied.

No treatment

NO INTERVENTION

One square on the back of each volunteers will be randomized to receive no treatment.

Interventions

Melatonin DRUG

Melatonin: Melatonin cream 0,5%; Melatonin: Melatonin cream 12,5%; Melatonin: Melatonin cream 2,5%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Gastroenheden, Herlev Hospital

Herlev, Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Sunburn; Erythema

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Cecilie Scheuer, Research Scholar

  Gastroenheden, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research scholar, medical student

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

DK (1)