Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-003023-10
    Sponsor's Protocol Code Number:03072013
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2013-003023-10
    A.3Full title of the trial
    MELATOX: Pharmacodynamic evaluation of topical use of melatonin as sun protection: a randomized, double blinded, placebo controlled crossover study on healthy volunteers.
    MELATOX: Evaluering af melatonins optagelse gennem huden ved anvendelse som solbeskyttelse.; et randomiseret, placebokontrolleret, dobbeltblindet overkrydsningsstudie med raske forsøgspersoner
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MELATOX: Pharmacodynamic evaluation of topical use of melatonin as sun protection: a study on healthy volunteers.
    MELATOX: Evaluering af melatonins optagelse gennem huden ved topikal anvendelse som solbeskyttelse: et studie på raske forsøgspersoner.
    A.4.1Sponsor's protocol code number03072013
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDepartment of Surgery, Herlev Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Copenhagen / CPO
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Surgery, Herlev Hospital
    B.5.2Functional name of contact pointIsmail Gögenur
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538689501
    B.5.6E-mailismail.gogenur@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMelatonin
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adverse effects of topical use of melatonin as sun protection.
    Bivirkninger ved topikal anvendelse af melatonin som solbeskyttelse.
    E.1.1.1Medical condition in easily understood language
    Adverse effects when using melatonin containing cream as a sun protectant.
    Bivirkninger ved brug af en melatonin holdig creme som solbeskyttelse.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10060933
    E.1.2Term Adverse event
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of subjective sleepiness after topikal treatment with cream containing melatonin 12,5% or placebo assessed by scoring with Karolinska Sleepiness Scale.
    Evaluering af subjektiv træthed undersøgt med Karolinska Sleepiness Scale efter topikal behandling med melatonin creme 12,5% eller placebo.
    E.2.2Secondary objectives of the trial
    - Evaluation of cognitive dysfunction assessed by Finger tapping test and Continous reaction time test.
    - Transdermal administration of melatonin assessed by analyzing bloodsamples.
    - Evaluation of melatonin distribution in urine and saliva after topical use of melatonin cream 12,5%.
    - Evaluation of influence on heart rate, bloodpressure, plus and temperature after topikal administration of melatonin cream 12,5%
    - Evaluering af kognitiv dysfunktion efter topikal anvendelse af melatonin creme 12,5% med Finger tapping test og Continous reaction time målinger.
    - Transdermal optagelse af melatonin i blodet undersøgt med analysering af blodprøver.
    - Undersøgelse af melatonins distribution i urin og spyt efter topikal behandling med melatonin creme 12,5%.
    - Evaluering af indflydelse på hjerterytme, blodtryk, puls og temperatur ved topikal brug af melatonin creme 12,5%
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Healthy volunteers of both sexes.
    - No shiftwork
    - No ingestion of caffeine containing food or beverages 24 hours before and under the study session.
    - Pittsburgh sleep quality index score <5
    - Hight 165-190 cm.
    - Weight 53-85 kg.
    - Raske forsøgspersoner af begge køn
    - Ingen skifteholdsarbejde
    - Ingen indtagelse af koffein holdige drikke eller spise 24 timer inden samt under selve forsøgs sessionen.
    - Pittsburgh sleep quality index score <5
    - Højde 165-190 cm.
    - Vægt 53-85 kg.
    E.4Principal exclusion criteria
    - Pregnancy
    - Active skin disease
    - Use of hypnotica or sedativa.
    - Known sleeping disorder.
    - Known allergy to substances in the cream
    - Graviditet
    - Aktiv hudsygdom
    - Medicinsk behandling for anden sygdom
    - Brug af hypnotika eller sedativa.
    - Kendt søvnlidelse.
    - Kendt allergi overfor indholdsstof i cremen
    E.5 End points
    E.5.1Primary end point(s)
    Subjective sleepiness assessed by Karolinska Sleepiness Scale
    Subjektiv træthed undersøgt med Karolinska Sleepiness Scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before treatment+1,2,3,4,5,6,7,8,9,12, 24 and 36 hours after treatment.
    Inden behandling+1,2,3,4,5,6,7,8,12, 24 og 36 timer efter behandling.
    E.5.2Secondary end point(s)
    - Cognitive dysfunction evaluated by Finger tapping test and Continous reaction time test after treatment with melatonin cream 12,5%.
    - Distribution of transdermal melatonin in blood after treatment with melatonin cream 12,5%.
    - Distributioin of transdermal melatonin in urine and saliva after treatment with melatonin cream 12,5%.
    - Influence of vital heart rate, blood pressure, plus and temperature by topikal treatment with melatonin cream 12,5%.
    - Kognitiv dysfunktion efter topikal behandling med melatonin creme 12,5% undersøgt med Finger tapping test og Continous reaction time test.
    - Koncentration af melatonin i blodet ved topikal anvendelse af melatonin creme 12,5%.
    - Koncentration af melatonin i urin og spyt efter topikal anvendelse af melatonin creme 12,5%.
    - Påvirkning af hjerterytme, blodtryk, puls og temperatur ved topikal brug af melatonin creme 12,5%.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before treatment+1,2,3,4,5,6,7,8,12, 24 and 36 hours after treatment.
    Inden behandling+1,2,3,4,5,6,7,8,12, 24 og 36 timer efter behandling.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-01
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 04:55:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA