SunburnPhase 1NCT01873430
The Sun Protective Effect of Melatonin
A Phase 1 study testing Melatonin in people with Sunburn, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunburn
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SunburnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilie Scheuer, Herlev Hospital
- Investigators
- Cecilie Scheuer, Research Scholar, Principal investigator, Gastroenheden, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873430
- Sponsor's protocol ID
- 2013-000629-30
- Status last verified
- Aug 2013
- First submitted
- 6 Jun 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01873430
- Acronym / sponsor ID
- 2013-000629-30
- Conditions
- Sunburn
- Keywords
- Melatonin, Sunburn, Erythema, Sunlight, Ultraviolet rays
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Melatonin: Melatonin cream 2,5% | Active comparator | Drug: MelatoninOne square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied |
| Melatonin: Melatonin cream 0,5% | Active comparator | Drug: MelatoninOne square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied. |
| Melatonin: Melatonin cream 12,5% | Active comparator | Drug: MelatoninOne square on the back of each volunteers will be randomized to have the above mentioned dose of melatonin cream applied. |
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin | Drug | Melatonin: Melatonin cream 0,5%, Melatonin: Melatonin cream 12,5%, Melatonin: Melatonin cream 2,5% |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
Related trials for Sunburn
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Randomized Trial of a Sun Safety Intervention for Young Adults
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Undergraduate Skin Cancer Prevention Trial
Skin Cancer
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Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilie Scheuer, Research Scholar principal investigator
Gastroenheden, Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin in people with Sunburn, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013; AzTrials last refreshed its copy on 30 Oct 2026.