<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02224937</url>
  </required_header>
  <id_info>
    <org_study_id>2013-003023-10</org_study_id>
    <secondary_id>2013-003023-10</secondary_id>
    <nct_id>NCT02224937</nct_id>
  </id_info>
  <brief_title>MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.</brief_title>
  <official_title>MELATOX: Evaluation of Percutaneous Dissolvement of Melatonin When Used as Sunscreen; a Randomized, Placebo Controlled, Double-blind Crossover Study on Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the percutaneous transportation and pharmacokinetics&#xD;
      of melatonincream 12,5% when used on 80% of the body area. A test battery consisting of&#xD;
      blood, saliva, urine samples at 1,2,3,4,5,6,7,8,12,24 and 36 hours after cream application.&#xD;
      Cognitive parameters are investigated using KSS, FTT and CRT tests at above mentioned time&#xD;
      points.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Karolinska Sleepiness Scale after application of melatonincream 12,5% on 80% of the body-surface area.</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.</time_frame>
    <description>Karolinska sleepiness scale is a valid scale for measurement of subjective sleepiness in individuals.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.</time_frame>
    <description>Finger tapping test is a simple way to investigate psychomotoric speed and control. Impaired psychomotoric speed is accepted as a predictor for cerebral dysfunction.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in serum melatonin concentration</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.</time_frame>
    <description>Blood samples are collected at the above mentioned time points. Serum melatonin is evaluated by laboratory tests.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in saliva melatonin concentration.</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure</time_frame>
    <description>Saliva samples are collected at above mentioned time points. The concentration of melatonin in saliva is tested using laboratory analyses.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in urine melatonin concentration</measure>
    <time_frame>0-4,4-8,8-12,12-24 and 24-36.</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measurement changes in bloodpressure and puls.</measure>
    <time_frame>1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure</time_frame>
    <description>Blood pressure and puls was monitored throughout the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Holter monitoring</measure>
    <time_frame>1-36 hours</time_frame>
    <description>Registration of alterations in heart rate throughout the time period of 0-36 hours will be continuously monitored using af Holter monitor.</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of changes in body-temperature</measure>
    <time_frame>1,12,24 and 36 hours post exposure</time_frame>
    <description>Body-temperature was monitored at 1,12,24 and 36 hours after cream application.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Solar Skin Damage</condition>
  <arm_group>
    <arm_group_label>Melatonin:Melatonincreme 12,5%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of melatonincream 12,5% on 80% of the body-surface at start of investigation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of placebo cream on 80% of the body-surface at start of investigation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melatonin</intervention_name>
    <arm_group_label>Melatonin:Melatonincreme 12,5%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers of both sexes&#xD;
&#xD;
          -  Age 18-65 years&#xD;
&#xD;
          -  No shiftwork&#xD;
&#xD;
          -  No intake of caffeine or alcohol one day before investigation, and under the&#xD;
             experiment.&#xD;
&#xD;
          -  Pittsburgh sleep quality index &lt;5&#xD;
&#xD;
          -  Height 165-190 cm&#xD;
&#xD;
          -  Weight 53-85 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active skin-disease&#xD;
&#xD;
          -  Use of hypnotic or sedative drugs.&#xD;
&#xD;
          -  Known sleeping disorder&#xD;
&#xD;
          -  Known allergy to contents of the cream.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecilie Ms Scheuer, ph.d.student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Køge Sygehus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herlev Sygehus</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>November 13, 2014</last_update_submitted>
  <last_update_submitted_qc>November 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Cecilie Scheuer</investigator_full_name>
    <investigator_title>ph.d.student</investigator_title>
  </responsible_party>
  <keyword>Melatonin</keyword>
  <keyword>Cognitive parameters</keyword>
  <keyword>pharmacodynamic</keyword>
  <keyword>pharmacokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224937
org study id: 2013-003023-10
secondary id: 2013-003023-10
nct id: NCT02224937
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: Changes in serum melatonin concentration
time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure.
description: 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.
measure: Changes in saliva melatonin concentration.
time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure
description: 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.
measure: Changes in urine melatonin concentration
time frame: 0-4,4-8,8-12,12-24 and 24-36.
description: 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.
measure: Measurement changes in bloodpressure and puls.
time frame: 1,2,3,4,5,6,7,8,12,24 and 36 hours post exposure
description: Blood pressure and puls was monitored throughout the study.
measure: Holter monitoring
time frame: 1-36 hours
description: Registration of alterations in heart rate throughout the time period of 0-36 hours will be continuously monitored using af Holter monitor.
measure: Measurement of changes in body-temperature
time frame: 1,12,24 and 36 hours post exposure
description: Body-temperature was monitored at 1,12,24 and 36 hours after cream application.
arm group label: Melatonin:Melatonincreme 12,5%
arm group type: Experimental
description: Application of melatonincream 12,5% on 80% of the body-surface at start of investigation.
arm group label: Placebo
arm group type: Placebo Comparator
description: Application of placebo cream on 80% of the body-surface at start of investigation.
intervention type: Drug
intervention name: Melatonin
arm group label: Melatonin:Melatonincreme 12,5%
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cecilie Ms Scheuer, ph.d.student
role: Principal Investigator
affiliation: Køge Sygehus
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Cecilie Scheuer
investigator title: ph.d.student
mesh term: Melatonin