Solar Skin DamagePhase 1NCT02224937
MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
A Phase 1 study testing Melatonin in people with Solar Skin Damage, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Solar Skin Damage
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2013to Feb 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers of both sexes
- Age 18-65 years
- No shiftwork
- No intake of caffeine or alcohol one day before investigation, and under the experiment.
- Pittsburgh sleep quality index <5
- Height 165-190 cm
- Weight 53-85 kg
Who cannot join
- Pregnancy
- Active skin-disease
- Use of hypnotic or sedative drugs.
- Known sleeping disorder
- Known allergy to contents of the cream.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application. Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time points.
- Conditions
- Solar Skin Damage
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Cognitive parameters, pharmacodynamic, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Melatonin:Melatonincreme 12,5% | Experimental | Application of melatonincream 12,5% on 80% of the body-surface at start of investigation. Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Application of placebo cream on 80% of the body-surface at start of investigation. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.
Karolinska sleepiness scale is a valid scale for measurement of subjective sleepiness in individuals.
This scale is used to detect any changes in subjective sleepiness over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body-surface area.
Measured: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Secondary outcomes (5)
Changes in continuous reaction time over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.
Continuous reaction time is a neuropsychological test designed to investigate endurance and attention by testing the persons ability to react to external stimuli over a given time period.
This parameter is used to detect changes in endurance and attention over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body-surface area.
Measured: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in finger tapping test over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.
Finger tapping test is a simple way to investigate psychomotoric speed and control. Impaired psychomotoric speed is accepted as a predictor for cerebral dysfunction.
This parameter is used to detect changes in psychomotoric speed and control over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body surface area.
Measured: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in serum melatonin concentration
Blood samples are collected at the above mentioned time points. Serum melatonin is evaluated by laboratory tests.
Blood samples are used to detect the changes in serum melatonin concentration after application of melatonin cream 12,5% on 80% of the body surface area.
Measured: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in saliva melatonin concentration.
Saliva samples are collected at above mentioned time points. The concentration of melatonin in saliva is tested using laboratory analyses.
Saliva samples are collected to detect changes in saliva melatonin concentration over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body surface area.
Measured: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure
Changes in urine melatonin concentration
Urine is collected in the above mentioned time intervals, and the concentration of melatonin is found by measuring the concentration of the metabolite 6-sulfatoxymelatonin using RIA.
The urine samples are collected and used to detect changes in 6-sulfatoxymelatonin concentration over a time period of 36 hours after application of melatonincream on 80% of the body surface area.
Measured: 0-4,4-8,8-12,12-24 and 24-36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar Skin DamageStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilie Scheuer, Zealand University Hospital
- Investigators
- Cecilie Ms Scheuer, ph.d.student, Principal investigator, Køge Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224937
- Sponsor's protocol ID
- 2013-003023-10
- Other IDs
- 2013-003023-10
- Status last verified
- Nov 2014
- First submitted
- 20 Aug 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02224937
- Acronym / sponsor ID
- 2013-003023-10
- Conditions
- Solar Skin Damage
- Keywords
- Melatonin, Cognitive parameters, pharmacodynamic, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2014 (actual)
- First posted
- 25 Aug 2014 (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 purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application. Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin:Melatonincreme 12,5% | Experimental | Drug: MelatoninApplication of melatonincream 12,5% on 80% of the body-surface at start of investigation. |
| Placebo | Placebo comparator | Drug: PlaceboApplication of placebo cream on 80% of the body-surface at start of investigation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy volunteers of both sexes
- Age 18-65 years
- No shiftwork
- No intake of caffeine or alcohol one day before investigation, and under the experiment.
- Pittsburgh sleep quality index <5
Key exclusion criteria (5 listed)
- Pregnancy
- Active skin-disease
- Use of hypnotic or sedative drugs.
- Known sleeping disorder
- Known allergy to contents of the cream.
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:Melatonincreme 12,5% |
| Placebo | Drug | Placebo |
Primary outcome
Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.
Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Karolinska sleepiness scale is a valid scale for measurement of subjective sleepiness in individuals. This scale is used to detect any changes in subjective sleepiness over a time period of 36 hours after application of melatonincream 12,5% on 80% of the body-surface area.
5 secondary outcomes
Changes in continuous reaction time over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.
Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in finger tapping test over a time period of 36 hours after application of melatonin cream 12,5% on 80% of the body surface area.
Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in serum melatonin concentration
Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
Changes in saliva melatonin concentration.
Time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure
Changes in urine melatonin concentration
Time frame: 0-4,4-8,8-12,12-24 and 24-36.
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 17 Nov 2014.
Related trials for Solar Skin Damage
RecruitingObservational study
Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria
Skin Melanoma, Cutaneous Melanoma
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 Ms Scheuer, ph.d.student principal investigator
Køge Sygehus
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 Solar Skin Damage, run by Zealand University 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 7 inclusion and 5 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 17 Nov 2014. 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?
Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area. (time frame: 1,2,3,4,5,6,7,8,12,24 and 36 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 17 Nov 2014.